Coronary Artery DiseaseLOCATIONNCT07388030
Lithotripsy Versus Balloon Angioplasty for Optimal Treatment of CAlcified Lesions With and Without Optical Coherence Tomography evaluatION
A study testing IVL Pretreatment + OCT-Guided Stent Implantation, IVL Pretreatment + Angiography-Guided Stent Implantation and Balloon Angioplasty (BA) Pretreatment + OCT-Guided Stent Implantation in people with Coronary Artery Disease and Severe Coronary Artery Disease, run by Shanghai Bluesail Boyuan Medical Technology Co., Ltd. at 1 site in China.
Trial summary
Severely calcified coronary artery disease means that calcium has built up in the blood vessels that supply the heart. This makes coronary procedures more difficult and increases the risk of complications during and after treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Severe Coronary Artery Disease, Coronary Artery Calcification
- What is being tested?
- IVL Pretreatment + OCT-Guided Stent Implantation, IVL Pretreatment + Angiography-Guided Stent Implantation and Balloon Angioplasty (BA) Pretreatment + OCT-Guided Stent Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,060 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2026to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Inclusion criteria:
- Age ≥18 years;
- Subject presents with:
- stable ischemic heart disease or
- acute coronary syndrome (non-ST-segment elevation myocardial infarction [NSTEMI] or unstable angina), or
- stabilized recent ST-segment elevation myocardial infarction (STEMI) (>48 hours prior to enrollment);
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- Subject has been fully informed and signed the Institutional Review Board (IRB) approved LOCATION trial Informed Consent Form (ICF) prior to any trial related procedures.
- Angiographic inclusion criteria：
- The reference diameter of each target vessel is ≥2.25 mm and ≤4.0 mm at the lesion site (visual estimation);
- The target lesion(s) have:
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- A stenosis ≥70% and <100% (visual estimation), or
- A stenosis of the target lesion ≥50% and <70% (visual estimation) with evidence of ischemia via:
- Positive stress testing (such as single-photon emission computed tomography, echocardiography, treadmill exercise test, etc.), or computed tomography-fractional flow reserve (CT-FFR) value ≤0.80, or;
- 24-hour Holter electrocardiogram: ST-segment elevation or depression of ≥1 mm in horizontal or down-sloping pattern lasting for at least 1 minute, with an interval of more than 1 minute between two episodes; combined with the patient presenting typical angina symptoms with Canadian Cardiovascular Society grading of angina pectoris II - IV;
- Pressure wire FFR or angioFFR value ≤0.80 or instantaneous wave-free ratio (iFR) value ≤0.89.
- 3.The target lesion has fluoroscopic evidence of severe calcium at the lesion site, defined via angiogram as fluoroscopic radiopacities noted without cardiac motion before contrast injection involving both sides of the arterial wall in at least 1 location and total length of calcium of at least 15 mm; All lesions in the non-target vessel, if any, that require treatment are successfully treated without complications prior to randomization, defined as final diameter stenosis ≤20% with final TIMI-3 flow, with no residual dissection grade ≥type B, and no transient or sustained angiographic complications (e.g. distal embolization, side branch closure), no chest pain lasting >5 minutes, and no ST-segment elevation or depression lasting >5 minutes.
Who cannot join
- Clinical exclusion criteria：
- Subject has undergone PCI in the target vessel or its branches within 12 months prior to randomization or prior CABG any time;
- Subject has undergone a PCI procedure in a non-target vessel that is unsuccessful or with complications within 30 days prior to randomization, including during the randomization procedure. Successful and uncomplicated PCI is defined as final diameter stenosis ≤20% with final TIMI-3 flow, no residual dissection grade≥ type B, no transient or sustained angiographic complications (e.g., distal embolization, side branch closure), no chest pain lasting >5 minutes, and no ST-segment elevation or depression lasting >5 minutes);
- PCI is planned within 12 months post randomization aside from a potential planned staged PCI as part of the randomized treatment strategy;
- Planned use in the randomized lesion(s) of a bare metal stent (BMS), bioresorbable scaffold (BRS), or non-stent treatment only;
- The investigator believes that based on the angiographic appearance that 1) it is unlikely that an OCT catheter can be delivered; 2) if randomized to no IVL, it is unlikely that the lesion(s) can be crossed and pre-dilated by balloon angioplasty alone; 3) if randomized to IVL, it is unlikely that the IVL catheter can be delivered to the lesion (note: pre-dilatation is allowed if necessary for IVL delivery);
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- Subject has undergone a prior transcatheter or surgical intervention for a non-coronary cardiac condition (e.g. a TAVR or left atrial appendage occlusion) within the prior 6 months, or is anticipated to need such a procedure within 1 year;
- Subject has severe stenosis or regurgitation of any heart valve, or moderate aortic stenosis or regurgitation;
- Subject has evidence of heart failure by at least one of the following:
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- Left ventricular ejection fraction (LVEF) ≤30% within 1 month prior to enrollment, or
- Current heart failure defined as dyspnea with minimal exertion or at rest (NYHA class III or IV within 1 month of the procedure), or
- Killip class ≥2 for post STEMI patients; 9.Subject is hemodynamically unstable as evidenced by a SBP of >160 mmHg or <90 mmHg or a heart rate of <50 bpm or >100 bpm (>110 bpm if in atrial fibrillation) 10.Subjects with known allergy to heparin unless bivalirudin will be used as the procedural anticoagulant; 11.Subjects with known allergy to contrast media that cannot be effectively pre-medicated or any prior anaphylaxis to contrast; 12.Subjects with known allergy to aspirin or both clopidogrel and ticagrelor; 13.History of a stroke within 6 months prior to enrollment, excluding transient ischemic attack (TIA) or any prior intracranial bleed; 14.History of active peptic ulcer or upper gastrointestinal bleeding within 6 months prior to enrollment; 15.Inability to tolerate dual antiplatelet therapy for at least 6 months; 16.Known malignancy or any condition with a life expectancy of ≤12 months; 17.Chronic kidney disease (CKD) with an estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m² or on dialysis; 18.Subject has a history of any cognitive or mental health condition that may interfere with the trial participation including all follow-up visits; 19.Subject is a female who is pregnant (women of child-bearing potential must have a negative pregnancy test within 15 days before the procedure); 20.Subject is participating in or has plans to participate in any other investigational drug or device trial that has not reached its primary endpoint.
- Angiographic Exclusion Criteria:
- There are no lesions in any target vessel (main epicardial coronary artery including its side branches) that requires treatment that do not meet all angiographic inclusion criteria;
- A target lesion is an unprotected LM lesion or an ostial lesion (RCA within 3 mm of the aorta proximal LAD or LCX within 3 mm of the LM);
- A target lesion is a true bifurcation with a severely calcified side branch that requires treatment but cannot be treated with IVL because of its size, angulation or other condition. A severely calcified side branch is defined via angiogram as fluoroscopic radiopacities noted without cardiac motion before contrast injection involving both sides of the arterial wall) Note: If a true bifurcation target lesion is included, the main branch must be severely calcified; the side branch may or may not be severely calcified. However, if the side branch is severely calcified, it must be eligible for IVL treatment. Otherwise, the final treatment for the side branch may be balloon angioplasty, a DCB or a DES as per the judgement of the operator. The main branch must be treated with a DES.
- A target lesion is totally occluded (100% diameter stenosis with TIMI flow ≤1);
- A target lesion contains giant thrombus (defined as angiographic length >2x the reference vessel diameter);
- Presence of an aneurysm within 10 mm of the target lesion;
- Angiographic evidence of severe dissection (type D - F defined by NHLBI classification) in the target lesion prior to device treatment;
- A target vessel has severe or excessive tortuosity or is deemed unsuitable for angioplasty by investigator judgement; Any intent to perform intravascular imaging during the randomization procedure (unless randomized to OCT).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110011
Yaling Han, MD, Doctor, +8624-28856114, yanjiao.zhang@jwmsgrp.com
Haiwei Liu
About this study
Severely calcified coronary artery disease means that calcium has built up in the blood vessels that supply the heart. This makes coronary procedures more difficult and increases the risk of complications during and after treatment.
The LOCATION Study is a large clinical study designed to compare different commonly used treatment strategies for patients with severely calcified coronary arteries who need a coronary stent. The study aims to find safer and more effective ways to prepare the artery and place the stent in order to improve long-term outcomes.
Read more
In this study, participants will be randomly assigned (like flipping a coin) to one of four treatment groups during their coronary procedure. The treatments differ in two ways: (1) how the calcified artery is prepared before placing the stent, and (2) how imaging is used to guide stent placement.
One method uses a shockwave-based device to help break calcium in the artery, while the other uses standard balloon treatment. For imaging guidance, one approach uses a high-resolution imaging catheter inside the artery, and the other relies on standard X-ray imaging. All participants will receive a standard, approved drug-eluting stent as part of routine care.
The main goal of the study is to determine which treatment approach best reduces serious heart-related problems over three years. These problems include heart-related death, heart attack in the treated vessel, or the need for another procedure on the same vessel.
Adults aged 18 years or older with significant coronary artery narrowing and severe calcium buildup may be eligible to participate. All participants must provide written informed consent before joining the study.
Participants will be followed during their hospital stay and through regular follow-up visits or phone calls for up to three years after the procedure. Information collected during the study will help doctors better understand how to treat patients with severely calcified coronary arteries in the future.
Participation in this study is voluntary, and patients may withdraw at any time without affecting their medical care. All study devices used in this trial are approved for clinical use, and patient privacy will be protected according to applicable regulations.
Read the detailed description
LOCATION Study is a prospective, multicenter, 2x2 factorial randomized controlled trial.
Number of Sites: Approximately 50 sites in China.
Trial Objectives:
Objective 1: To evaluate the efficacy and safety of coronary intravascular lithotripsy (IVL) compared with balloon angioplasty (BA) for pretreatment of severely coronary calcified lesions prior to implantation of stents.
Objective 2: To evaluate the efficacy of optical coherence tomography (OCT)-guided compared with angiography-guided stent implantation in severely coronary calcified lesions.
Trial Hypotheses:
Hypotheses 1: IVL pretreatment of severely calcified coronary artery lesions will reduce the 3-year risk of target vessel failure (TVF, a composite of cardiac death, target vessel myocardial infarction [TVMI], or clinically-driven target vessel revascularization [TVR]) compared with BA pretreatment.
Hypotheses 2: OCT-guided percutaneous coronary intervention (PCI) will reduce 3-year risk of TVF compared with angiography-guided PCI in severely coronary calcified lesions.
Trial Population:Patients with one or more angiographically severely calcified coronary lesions
Trial Devices:
IVL device: SoniCrackerTM Coronary IVL Therapy System (Shanghai Bluesail Boyuan Medical Technology co., Ltd) BA Devices: standard commercially approved balloon angioplasty devices including high-pressure balloons, scoring balloons, and cutting balloons, without brand restriction OCT device: Intravascular Imaging System (Nanjing Forssmann Medical Technology Co., Ltd)
Follow-up Visits:
Follow-up will range between 1-year minimum and 3-year maximum. Follow-up will be conducted at discharge, at 30 (±7) days, 180 (±7) days, at 1 year (±30 days), 2 years (±30 days), at 3 (±30 days) years with clinic visit or phone calls. When the last patient reaches 1 year follow-up, an additional "sweep visit" will be performed in all patients who have not had follow-up within 30 days. Additional visits will not be performed after this sweep visit.
Duration:The period of this trial is expected to be approximately 4 years.
Sample size Calculation:
This trial is expected to enroll 3,060 patients, and the sample size calculation is based on the cumulative incidence of TVF as the primary endpoint.
For Hypothesis 1: We expect that the rate of TVF in the BA group will be 7.0%, 12.5%, 16.0% at 1-year, 2-year, and 3-year follow-up, respectively. Assuming a 25% risk reduction, (i.e. the hazard ratio (HR) between the IVL group and the BA group is 0.75), it is estimated that the rate of TVF in the IVL group will be 5.3%, 9.4%, and 12.0% at 1-year, 2-year, and 3-year follow-up, respectively. The subject enrollment period is expected to be 3 years, with annual enrollment rates of 30%, 40%, and 30% respectively. Accounting for a 5% dropout rate in both groups, 3,060 total randomized patients provide 80% power to reject the null hypothesis at a two-sided α level of 0.05.
For Hypothesis 2: We expected that the rate of TVF in the angiography-guided group will be 7.7%, 13.8%, 17.6% at 1-year, 2-year, and 3-year follow-up, respectively. Assuming a 27% risk reduction (i.e. the HR between the OCT-guided group and the angiography-guided group is 0.73), the rate of TVF in the OCT-guided group will be 5.6%, 10.1%, and 12.9% at 1-year, 2-year, and 3-year follow-up, respectively. The subject enrollment period is expected to be 3 years, with annual enrollment rates of 30%, 40%, and 30% respectively. Accounting for a 5% dropout rate in both groups, 2,326 total randomized patients provide 80% power to reject the null hypothesis at a two-sided α level of 0.05. With 3,060 total subjects, 89.6% power is present to reject the null hypothesis.
No interaction between hypotheses 1 and 2 are expected; that is, the benefit of OCT guidance is expected to accrue to a similar degree after both IVL and BA pre-treatment of severely calcified lesions; as such, adjustment for multiplicity is not required. Thus, a total enrollment of 3,060 subjects is planned, with 1530 subjects in each group (IVL vs. BA vessel preparation, and OCT vs. angiography guidance).
Background:
Coronary artery disease (CAD) is a major cardiovascular disorder that imposes a substantial burden on global health. Percutaneous coronary intervention (PCI), as an effective therapeutic strategy for CAD, has been increasingly utilized in clinical practice. With the aging of the population, the proportion and severity of coronary artery calcified lesions have shown a progressive increase. Severely calcified lesions represent one of the most prevalent complex lesion subtypes in CAD that significantly increases the technical difficulty of coronary intervention and thus poses a major challenge to cardiovascular interventional physicians. Notably, patients with calcified lesions have a significantly higher incidence of perioperative complications and long-term major adverse cardiovascular events (MACE). [1] For the pretreatment of calcified lesions, specialized balloons are typically employed, including high-pressure non-compliant balloons, cutting balloons and scoring balloons, as well as coronary atherectomy. However, these approaches have certain limitations. For instance, coronary atherectomy modifies lesion compliance and enlarges the lumen through the ablation of calcified plaques; yet, it may increase the risk of distal embolization, which can result in slow flow or no-reflow. Additionally, its complexity impedes its widespread adoption. Meanwhile, cutting balloons and scoring balloons have not been proven to enhance clinical outcomes in severe calcification.
Coronary intravascular lithotripsy (IVL) is derived from urological lithotripsy techniques. The IVL system consists of miniaturized, arrayed lithotripsy emitters enclosed within a balloon that generate a localized field effect at calcified sites, thereby optimizing energy delivery for the treatment of coronary calcification. This process modifies vascular compliance while preserving the integrity of the native fibroelastic components of the vessel wall, thus reducing vascular injury. The DISRUPT CAD I trial (NCT02650128) [2], the first study investigating IVL, enrolled 60 patients and demonstrated a 98% device success rate for IVL. Following IVL, all patients underwent successful drug-eluting stent (DES) implantation. Subsequently, a series of prospective, multicenter studies have been conducted, including DISRUPT CAD II (NCT03328949) [3], DISRUPT CAD III (NCT03595176) [4-5], and Disrupt CAD IV (NCT04151628) [6-7]. These studies have demonstrated the efficacy and safety of IVL in the management of severe coronary calcified lesions.
The SoniCrackerTM Coronary Intravascular Lithotripsy Therapy System is an IVL product developed by Shanghai Bluesail Boyuan Medical Technology co., Ltd. The device has completed a prospective, multicenter, single-arm pre-market clinical study, enrolling a total of 184 patients with severe coronary artery calcification in China, which showed a procedural success rate of 96.7% (defined as a residual in-stent stenosis ≤30% following stent implantation and without in-hospital major adverse cardiac events). Angiographic success (defined as residual in-stent stenosis ≤30% following stent implantation and without serious angiographic complications) and device success (defined as the IVL catheter successfully crossing the target lesion and delivering lithotripsy without serious angiographic complications) rates were both 100%, with no cases of post-stent residual stenosis >30% or severe angiographic complications. No intraoperative MACE occurred, and the postoperative 6-month MACE rate was 4.9%. The target lesion failure (TLF) rates at 1 month and 6 months post-procedure were 3.3% and 4.4%, respectively. Optical coherence tomography (OCT) subgroup analysis showed immediate post-procedure minimum stent area of 5.30±1.74 mm², minimum stent lumen diameter of 2.56±0.42 mm, immediate lumen gain diameter of 0.98±0.57 mm, and immediate lumen gain area of 3.29±1.45 mm² (data not published). The trial confirmed the device's favorable safety and efficacy. However, there is currently a lack of randomized controlled clinical trial data comparing IVL technology with other calcified lesion management strategies to further validate the superiority of IVL.
Current guidelines recommend the use of intravascular imaging guidance during PCI for complex coronary lesions (especially left main, true bifurcation, and long lesions). However, there remains a lack of intravascular imaging-guided studies with sufficient statistical power to confirm its efficacy in severely calcified lesions. Common clinical intravascular imaging modalities primarily include intravascular ultrasound (IVUS) and OCT. Compared to IVUS, OCT offers distinct advantages in evaluating calcified lesions: it can precisely assess calcification thickness and more accurately quantify the volume of calcified lesions, which is of great significance for determining optimal treatment strategies. Therefore, this trial is designed to evaluate the clinical benefits of OCT-guided stent implantation specifically in severe coronary calcified lesions.
The present clinical trial will employ the SoniCracker™ Coronary Intravascular Lithotripsy Therapy System and Intravascular Imaging System (Nanjing Forssmann Medical Technology Co., Ltd) to further evaluate two key aspects: first, the efficacy and safety of IVL using the SoniCracker™ system versus balloon angioplasty as pretreatment for severely coronary calcified lesions prior to stent implantation; second, the efficacy and safety of OCT-guided versus angiography-guided stent implantation in severely coronary calcified lesions.
Analysis of Potential Benefits
The devices used in the trial have demonstrated safety and efficacy in pre-market clinical trials and has obtained marketing approval from the China National Medical Products Administration (NMPA). Potential benefits include: achieving immediate procedural success, adequate stent expansion, reducing intraoperative complications, improving long-term vascular patency, and clinical outcomes, etc. Participation in this trial is purely voluntary, and enrolled subjects will not receive direct additional benefits. However, information collected from this trial may help deepen the understanding of clinical outcomes in percutaneous coronary intervention (PCI). Ultimately, this knowledge may provide physicians with more information to help improve the treatment of future patients.
Data Management System
The data collection/management system for this trial is an EDC (Electronic Data Capture) system. This is a validated electronic data capture system with audit trial management and user permission management capabilities.
Source data verification is performed to ensure the accuracy and completeness of key study variables. Protocol deviations, adverse events, and serious adverse events are documented and reported according to the study protocol and applicable regulatory and local regulatory requirements.
General Principles
Continuous variables will be summarized as the number of observations, number of missing values, mean, standard deviation, median, quartiles, and range. Categorical variables will be summarized as the number of observations, number of missing values, frequencies, and percentages. Baseline clinical, demographic, laboratory and procedural characteristics will be summarized by randomized treatment group.
All statistical analyses will be performed using SAS software, Version 9.4 or greater. For comparison between the two groups, all hypothesis tests are conducted by two-sided test, α=0.05. The efficacy analysis will be conducted according to the intention-to-treat (ITT) principle. Kaplan-Meier curves and log-rank test will be used to analyze and compare the timing of the first event in each group. P <0.05 is statistically significant. The reliability of all 2-sided confidence intervals (CI) is 95%, and Cox proportional risk regression model is used to determine the hazard ratio (HR).
Ethical Considerations
The study is conducted in compliance with the Declaration of Helsinki, applicable regulatory requirements, and approvals from institutional review boards or ethics committees at each participating site. All participants provide written informed consent prior to enrollment. Participant confidentiality is maintained throughout the study.
The Clinical Events Committee (CEC) will be established for this study.The Crossover Device Evaluation Committee will be established to provide impartial assessment of crossover subjects.The imaging core lab(s) will provide central reading/analysis for angiographic and OCT images generated pre-procedure,during the procedure, and post-procedure at enrolling sites.
Data Safety Monitoring Board (DSMB)
A Data Safety Monitoring Board will be established for this clinical trial to assess, at intervals during the trial, the data and to recommend to the Steering Committee whether to continue, suspend, modify, or terminate the trial early. The DSMB will consist of a minimum of three (3) members, one of which will be a statistician. The DSMB will not be affiliated with the Sponsor or its members will not be actively participating in the trial. Details of the DSMB's composition, specific review processes, and operating procedures are outlined in its charter.
- Being tested
- IVL Pretreatment + OCT-Guided Stent Implantation, IVL Pretreatment + Angiography-Guided Stent Implantation, Balloon Angioplasty (BA) Pretreatment + OCT-Guided Stent Implantation, Balloon Angioplasty (BA) Pretreatment + Angiography-Guided Stent Implantation
- Keywords
- severe coronary calcified lesions, intravascular lithotripsy (IVL), balloon angioplasty (BA), optical coherence tomography (OCT)-guided, angiography-guided, target vessel failure (TVF), percutaneous coronary intervention (PCI)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVL Pretreatment + OCT-Guided Stent ImplantationDevice
Subjects who have signed ICF and have met all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 to IVL vessel preparation strategy or balloon angioplasty vessel preparation strategy. Concurrently, subjects will randomly be assigned in a 1:1 ratio to receive OCT-guidance or angiographic-guidance of the PCI procedure.
Subject randomization in each of the 4 groups will be stratified by site and diabetes in varying block sizes of 2, 4 or 6. Randomization will be conducted with the use of an interactive web response system (IWRS).
IVL Pretreatment + Angiography-Guided Stent ImplantationDevice
Subjects who have signed ICF and have met all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 to IVL vessel preparation strategy or balloon angioplasty vessel preparation strategy. Concurrently, subjects will randomly be assigned in a 1:1 ratio to receive OCT-guidance or angiographic-guidance of the PCI procedure.
Subject randomization in each of the 4 groups will be stratified by site and diabetes in varying block sizes of 2, 4 or 6. Randomization will be conducted with the use of an interactive web response system (IWRS).
Balloon Angioplasty (BA) Pretreatment + OCT-Guided Stent ImplantationDevice
Subjects who have signed ICF and have met all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 to IVL vessel preparation strategy or balloon angioplasty vessel preparation strategy. Concurrently, subjects will randomly be assigned in a 1:1 ratio to receive OCT-guidance or angiographic-guidance of the PCI procedure.
Subject randomization in each of the 4 groups will be stratified by site and diabetes in varying block sizes of 2, 4 or 6. Randomization will be conducted with the use of an interactive web response system (IWRS).
Balloon Angioplasty (BA) Pretreatment + Angiography-Guided Stent ImplantationDevice
Subjects who have signed ICF and have met all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 to IVL vessel preparation strategy or balloon angioplasty vessel preparation strategy. Concurrently, subjects will randomly be assigned in a 1:1 ratio to receive OCT-guidance or angiographic-guidance of the PCI procedure.
Subject randomization in each of the 4 groups will be stratified by site and diabetes in varying block sizes of 2, 4 or 6. Randomization will be conducted with the use of an interactive web response system (IWRS).
| Study group | Role | What they receive |
|---|---|---|
| IVL pre-treatment plus OCT-guided group | Experimental | (1st OCT) perform OCT after the small balloon pre-dilatation but before the IVL; then IVL is performed* followed by the 1:1 high-pressure balloon pre-dilatation followed by the 2nd OCT; then implant the DES and perform post-dilatation with a high-pressure balloon at ≥18 atm (mandatory); then perform the final OCT (3rd OCT). Assess the stent to determine if further PCI is required to optimize stent implantation - either maximize stent expansion or treat malapposition, tissue protrusion, a major edge dissection or untreated reference segment disease. If further stent optimization is required, do so, after which a final OCT run must be performed again (4th OCT). Note: If IVL is unable to cross or dilate the lesion, rotational atherectomy, orbital atherectomy, or excimer laser should be performed followed by IVL. OCT must still be performed prior to stenting. Investigators should use IVL in accordance with the device's instructions for use. Receives: Device: IVL Pretreatment + OCT-Guided Stent Implantation |
| IVL pre-treatment plus angiography-guided group | Active comparator | An attempt should be made to cross the target lesion with the IVL catheter after the 1.5 mm or 2.0 mm balloon dilation. If the IVL will not cross the lesion, a larger balloon or atherectomy may be used - then IVL must be performed*. Following successful IVL, pre-dilatation must be performed and be successful (complete balloon expansion) with a high-pressure balloon sized 1:1 to the distal reference segment prior to stenting (mandatory); then one or more stents are implanted (DES only); then post-dilatation must be performed with a high-pressure balloon at ≥18 atm (mandatory). A final OCT run blinded to the operator is then performed as the last procedure. NOTE: Investigators should use IVL in accordance with the device's instructions for use. Receives: Device: IVL Pretreatment + Angiography-Guided Stent Implantation |
| balloon angioplasty pre-treatment plus OCT-guided group | Active comparator | (1st OCT) perform baseline OCT after the 1.5 or 2.0 mm balloon; then perform balloon pre-dilatation with a high-pressure balloon sized 1:1 to the distal RVD*; then perform OCT again (2nd OCT); then implant the DES and perform post-dilatation with a high-pressure balloon at ≥18 atm (mandatory); then perform the final OCT (3rd OCT). Assess the stent to determine if further PCI is required to optimize stent implantation - either maximize stent expansion or treat malapposition, tissue protrusion, a major edge dissection or untreated reference segment disease. If further stent optimization is required, do so, after which a final OCT run must be performed again (4th OCT). Receives: Device: Balloon Angioplasty (BA) Pretreatment + OCT-Guided Stent Implantation |
| balloon angioplasty pre-treatment plus angiography-guided group | Active comparator | pre-dilatation must be successful (complete balloon expansion) with a high-pressure balloon (or scoring balloon, cutting balloon, etc.) sized 1:1 to the distal reference segment (mandatory)*; then one or more stents are implanted (DES only); then post-dilatation must be performed with a high-pressure balloon at ≥18 atm (mandatory). *Note: if the 1:1 pre-dilatation balloon is unable to be fully expanded, rotational atherectomy, orbital atherectomy, or excimer laser may be performed. Crossover to IVL is not allowed. After atherectomy or excimer laser, the lesion must again be successfully pre-dilated (complete balloon expansion) with a high-pressure balloon sized 1:1 to the distal reference segment (mandatory) prior to stenting. A final OCT run blinded to the operator is then performed as the last procedure; Receives: Device: Balloon Angioplasty (BA) Pretreatment + Angiography-Guided Stent Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Vessel Failure (TVF) at 3 years
Composite time-to-first event rate of cardiac death, target vessel myocardial infarction (TV-MI), or ischemia-driven target vessel revascularization (iTVR) at 3 years, assessed when the last enrolled patient reaches 1-year follow-up
Measured: 3 years
Secondary outcomes (27)
TVF （Target Vessel Failure ）(at 1 and 2 years)
Measured: 1 and 2 years
Target Lesion Failure (TLF)
defined as composite of cardiac death, TVMI, or ischemia-driven target lesion revascularization (iTLR); 3.Major Adverse Cardiovascular Events (MACE), defined as cardiac death, all MI, or TVR;
Measured: 30 days, 6 months ,1 year, 2 years, and 3 years
Major Adverse Cardiovascular Events (MACE)
defined as cardiac death, all MI, or TVR;
Measured: 30 days, 6 months,1 year, 2 years, and 3 years
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
including all-cause death, MI, stroke, or any revascularization;
Measured: 30 days, 6 months,1 year, 2 years, and 3 years
Cardiac death
Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all cardiac procedure related deaths including those related to concomitant treatment.
Measured: 30 days, 6 months,1 year, 2 years, and 3 years
Incidence of stent thrombosis
definite or probable stent thrombosis according to the Academic Research Consortium (ARC) criteria.
Measured: 30 days, 6 months,1 year, 2 years, and 3 years
Severe angiographic complications
including type D-F dissection (NHLBI classification), vascular perforation, acute vessel occlusion, persistent slow flow or persistent no-reflow during the procedure;
Measured: Immediate post-procedure
Procedural strategy success
defined as successful passage of the randomized study device through the target lesion, successful study device balloon expansion, successful stent placement with residual stenosis ≤20%, and no occurrence of MACE during hospitalization; Note: Small balloons for pre-dilatation are permitted in the IVL arm. Crossovers to any device (rotational atherectomy, orbital atherectomy, excimer laser, high-pressure, or cutting/scoring balloons) in the IVL arm are defined as a failure. Crossovers to IVL in the BA arm are not permitted but if used (protocol violation), this is a procedural failure. If rotational atherectomy, orbital atherectomy, or excimer laser are required for study device delivery in BA arm, this is also defined as a procedural failure.
Measured: Immediate post-procedure
Post-procedural minimum stent area (MSA) at the site of maximum calcification and across the entire target lesion;
Measured: Immediate post-procedure
Post-procedural mean stent area
Measured: Immediate post-procedure
Post-procedural minimum lumen diameter (MLD)
MLD refers to the minimum lumen diameter within the stent post-procedure.
Measured: Immediate post-procedure
Minimum stent expansion
Minimum stent expansion is the minimum lumen area within the stent divided by the average of proximal and distal reference lumen areas x 100
Measured: Immediate post-procedure
Stent malposition
defined as distance from stent struts to the vessel wall ≥0.4 mm and the length of stent malposition ≥1 mm;
Measured: Immediate post-procedure
Number of calcification fractures
Measured: Immediate post-procedure
Major and minor edge dissection
Edge dissection is classified as major if it involves ≥60 degrees of the vessel circumference at the dissection site and measures ≥3 mm in length or as minor if there is any visible edge dissection involving <60 degrees of the vessel circumference or <3 mm in length;
Measured: Immediate post-procedure
Major and minor tissue protrusion
Tissue protrusion is classified as major if the protrusion area/stent area at the site of tissue protrusion is ≥10% and the minimal intrastent flow area is <90% of the proximal or distal reference area. Note, the minimum in-stent flow area is the minimum value compared with the difference between the stent area and the prolapse area. Tissue protrusion is classified as minor if the protrusion area/stent area at the site of tissue protrusion is <10%, or is ≥10% but the minimal intraluminal flow area is ≥90% of proximal or distal reference area;
Measured: Immediate post-procedure
Incidence of Untreated reference segment disease
Untreated reference segment disease is defined as focal disease with an untreated minimal lumen area (MLA) <4.5 mm2 within 5 mm from the proximal and/or distal stent edges.
Measured: Immediate post-procedure
Target vessel myocardial infarction (TV-MI)
consists of periprocedural MI and spontaneous MI that arise from the target vessel., spontaneous MI using the 4th UDMI, peri-procedural MI using SCAI
Measured: 30 days, 6 months,1 year, 2 years, and 3 years
ischemia-driven target vessel revascularization (iTVR)
repeat revascularization of the target vessel with ischemic symptoms and angiographic evidence
Measured: 30 days, 6 months,1 year, 2 years, and 3 years
MI （Myocardial Infarction）
consists of periprocedural MI and spontaneous MI, spontaneous MI using the 4th UDMI, peri-procedural MI using SCAI target vessel revascularization, Repeat revascularization of the target vessel
Measured: 30 days, 6 months,1 year, 2 years, and 3 years
all-cause death
Measured: 30 days, 6 months,1 year, 2 years, and 3 years
Stoke
Measured: 30 days, 6 months,1 year, 2 years, and 3 years
any revascularization
Measured: 30 days, 6 months,1 year, 2 years, and 3 years
Post-procedural mean lumen diameter(LD)
LD refers to the average value of lumen diameter measurements calculated by averaging data from all cross-sections throughout the stent
Measured: Immediate post-procedure
Mean stent expansion
Mean stent expansion is the mean stent area (stent volume/analysed stent length) divided by the average of proximal and distal reference lumen areas x 100
Measured: Immediate post-procedure
Thickness (full-layer or partial) of calcification （mm)
Measured: Immediate post-procedure
Depth of calcification fractures(mm）
Measured: Immediate post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start20 Mar 2026 (estimated)
- Primary completion20 Jan 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The LOCATION study adopts a \*\*prospective, multicenter, 2×2 factorial randomized controlled model\*\* for severe coronary calcified lesions. Key details: 1. \*\*Randomization\*\*: 3,060 patients are 1:1 randomized to IVL/BA pretreatment and 1:1 to OCT/angiography guidance (4 parallel groups), stratified by site and diabetes with block sizes 2/4/6 via IWRS. 2. \*\*Interventions\*\*: IVL (SoniCracker™) vs standard BA for lesion prep; OCT (Nanjing Forssmann) vs angiography for stent guidance. 3. \*\*Crossover Rules\*\*: BA→IVL prohibited; IVL→other devices allowed only for specific criteria (recorded as failure). 4. \*\*Blinding\*\*: Open-label for investigators/subjects; core lab and CEC adjudicate outcomes blindly. 5. \*\*Follow-up\*\*: 30 days, 6 months, 1/2/3 years + sweep visit; primary endpoint is 3-year TVF. 6. \*\*Analysis Sets\*\*: ITT (efficacy), PP (sensitivity), SS (safety).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,060 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yaling Han, Principal investigator, The General Hospital of Northern Theater CommandGregg W. Stone, Study chair, Icahn School of Medicine at Mount Sinai, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388030
- Sponsor's protocol ID
- LFBY-202504
- Acronym
- LOCATION
- Status last verified
- Dec 2025
- First submitted
- 15 Jan 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study has no plan to share de-identified individual participant data (IPD) with researchers outside the primary study team. The reasons for this decision are as follows: Informed Consent \& Ethical Commitment: The informed consent documents for this study do not include provisions for IPD sharing, as participants only consented to data use for the original analysis of this study. This approach has been reviewed and approved by the Institutional Review Board/Ethics Committee (IRB/IEC) to uphold ethical commitments and avoid using data beyond the scope of participant understanding.
Publications
[16] Han Y, Jing Q, Liu H, et al. A novel coronary intravascular Lithotripsy device in patients with severely calcified lesions: LEAD-FIM study. Presented at EuroPCR 2024.
Kirtane AJ, Genereux P, Lewis B, Shlofmitz RA, Dohad S, Choudary J, Dahle T, Pineda AM, Shunk K, Maehara A, Popma A, Redfors B, Ali ZA, Krucoff M, Armstrong E, Kandzari DE, O'Neill W, Kraemer C, Stiefel KM, Jones DE, Chambers J, Stone GW; ECLIPSE Investigators. Orbital atherectomy versus balloon angioplasty before drug-eluting stent implantation in severely calcified lesions eligible for both treatment strategies (ECLIPSE): a multicentre, open-label, randomised trial. Lancet. 2025 Apr 12;405(10486):1240-1251. doi: 10.1016/S0140-6736(25)00450-7. Epub 2025 Mar 30.
PubMed 40174596Moussa ID, Klein LW, Shah B, Mehran R, Mack MJ, Brilakis ES, Reilly JP, Zoghbi G, Holper E, Stone GW. Consideration of a new definition of clinically relevant myocardial infarction after coronary revascularization: an expert consensus document from the Society for Cardiovascular Angiography and Interventions (SCAI). J Am Coll Cardiol. 2013 Oct 22;62(17):1563-70. doi: 10.1016/j.jacc.2013.08.720.
PubMed 24135581Blachutzik F, Meier S, Weissner M, Schlattner S, Gori T, Ullrich-Daub H, Gaede L, Achenbach S, Mollmann H, Chitic B, Aksoy A, Nickenig G, Weferling M, Dorr O, Boeder N, Bayer M, Elsasser A, Hamm C, Nef H; ROTA.Shock Investigators. Comparison of Coronary Intravascular Lithotripsy and Rotational Atherectomy in the Modification of Severely Calcified Stenoses. Am J Cardiol. 2023 Jun 15;197:93-100. doi: 10.1016/j.amjcard.2023.02.028. Epub 2023 Apr 2.
PubMed 37012181Mousa MAA, Bingen BO, Al Amri I, Mertens BJA, Taha S, Tohamy A, Youssef A, Jukema JW, Montero-Cabezas JM. Efficacy and Safety of Intravascular Lithotripsy Versus Rotational Atherectomy in Balloon-Crossable Heavily Calcified Coronary Lesions. Cardiovasc Revasc Med. 2023 Mar;48:1-6. doi: 10.1016/j.carrev.2022.10.011. Epub 2022 Oct 29. No abstract available.
PubMed 36336588Cubero-Gallego H, Calvo-Fernandez A, Tizon-Marcos H, Aparisi A, Gomez-Lara J, Amat-Santos I, Fuertes M, Santos-Martinez S, Salvatella N, Garcia-Guimaraes M, Negrete A, Mohandes M, Gomez-Hospital JA, Moris C, Vaquerizo B. Real-World Multicenter Coronary Lithotripsy Registry: Long-Term Clinical Follow-Up. J Invasive Cardiol. 2022 Oct;34(10):E701-E708. doi: 10.25270/jic/22.00058. Epub 2022 Aug 30.
PubMed 36075883Wong B, El-Jack S, Newcombe R, Glenie T, Armstrong G, Khan A. Shockwave Intravascular Lithotripsy for Calcified Coronary Lesions: First Real-World Experience. J Invasive Cardiol. 2019 Mar;31(3):46-48. doi: 10.25270/jic/19.00048. Epub 2019 Feb 15.
PubMed 30765621Rodriguez-Leor O, Cid-Alvarez AB, Lopez-Benito M, Gonzalo N, Vilalta V, Diarte de Miguel JA, Lopez LF, Jurado-Roman A, Diego A, Oteo JF, Cuellas C, Trillo R, Travieso A, Alfonso F, Carrillo X, Vegas-Valle JM, Cortes-Villar C, Pascual I, Munoz Camacho JF, Flores X, Vera-Vera S, Moreu J, Barreira de Sousa G, Marti D, Jimenez-Mazuecos J, Fuertes M, Ocaranza R, de la Torre Hernandez JM, Lozano F, Solana Martinez SG, Gomez-Lara J, Perez de Prado A; REPLICA-EPIC18 Investigators. A Prospective, Multicenter, Real-World Registry of Coronary Lithotripsy in Calcified Coronary Arteries: The REPLICA-EPIC18 Study. JACC Cardiovasc Interv. 2024 Mar 25;17(6):756-767. doi: 10.1016/j.jcin.2023.12.018. Epub 2024 Feb 21.
PubMed 38385926Tian F, Zhou SS, Liu JH, Chen H, Sun ZJ, Chen L, Wang Q, Jing J, Chen YD. Treatment of severely calcified coronary artery disease by intravascular lithotripsy primary outcomes and 180-day follow-up from the Chinese SOLSTICE Trial. J Geriatr Cardiol. 2023 Jan 28;20(1):32-39. doi: 10.26599/1671-5411.2023.01.005.
PubMed 36875163Hill JM, Kereiakes DJ, Shlofmitz RA, Klein AJ, Riley RF, Price MJ, Herrmann HC, Bachinsky W, Waksman R, Stone GW; Disrupt CAD III Investigators. Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease. J Am Coll Cardiol. 2020 Dec 1;76(22):2635-2646. doi: 10.1016/j.jacc.2020.09.603. Epub 2020 Oct 15.
PubMed 33069849Saito S, Yamazaki S, Takahashi A, Namiki A, Kawasaki T, Otsuji S, Nakamura S, Shibata Y; Disrupt CAD IV Investigators. Intravascular Lithotripsy for Vessel Preparation in Severely Calcified Coronary Arteries Prior to Stent Placement - Primary Outcomes From the Japanese Disrupt CAD IV Study. Circ J. 2021 May 25;85(6):826-833. doi: 10.1253/circj.CJ-20-1174. Epub 2021 Feb 5.
PubMed 33551398Kereiakes DJ, Hill JM, Ben-Yehuda O, Maehara A, Alexander B, Stone GW. Evaluation of safety and efficacy of coronary intravascular lithotripsy for treatment of severely calcified coronary stenoses: Design and rationale for the Disrupt CAD III trial. Am Heart J. 2020 Jul;225:10-18. doi: 10.1016/j.ahj.2020.04.005. Epub 2020 Apr 18.
PubMed 32470635Ali ZA, Nef H, Escaned J, Werner N, Banning AP, Hill JM, De Bruyne B, Montorfano M, Lefevre T, Stone GW, Crowley A, Matsumura M, Maehara A, Lansky AJ, Fajadet J, Di Mario C. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: The Disrupt CAD II Study. Circ Cardiovasc Interv. 2019 Oct;12(10):e008434. doi: 10.1161/CIRCINTERVENTIONS.119.008434. Epub 2019 Sep 25.
PubMed 31553205Brinton TJ, Ali ZA, Hill JM, Meredith IT, Maehara A, Illindala U, Lansky A, Gotberg M, Van Mieghem NM, Whitbourn R, Fajadet J, Di Mario C. Feasibility of Shockwave Coronary Intravascular Lithotripsy for the Treatment of Calcified Coronary Stenoses. Circulation. 2019 Feb 5;139(6):834-836. doi: 10.1161/CIRCULATIONAHA.118.036531. No abstract available.
PubMed 30715944Chinese Society of Cardiology, Chinese Medical Association; Editorial Board of Chinese Journal of Cardiology. [Guidelines for percutaneous coronary intervention (2025)]. Zhonghua Xin Xue Guan Bing Za Zhi. 2025 Jul 24;53(7):717-745. doi: 10.3760/cma.j.cn112148-20250422-00302. Chinese.
PubMed 40506224
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lithotripsy Versus Balloon Angioplasty for Optimal Treatment of CAlcified Lesions With and Without Optical Coherence Tomography evaluatION
- ClinicalTrials.gov ID
- NCT07388030
- Acronym / sponsor ID
- LOCATION / LFBY-202504
- Keywords
- severe coronary calcified lesions, intravascular lithotripsy (IVL), balloon angioplasty (BA), optical coherence tomography (OCT)-guided, angiography-guided, target vessel failure (TVF), percutaneous coronary intervention (PCI)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,060 participants (estimated)
- Lead sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- 20 Jan 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Severely calcified coronary artery disease means that calcium has built up in the blood vessels that supply the heart. This makes coronary procedures more difficult and increases the risk of complications during and after treatment.
The LOCATION Study is a large clinical study designed to compare different commonly used treatment strategies for patients with severely calcified coronary arteries who need a coronary stent. The study aims to find safer and more effective ways to prepare the artery and place the stent in order to improve long-term outcomes.
In this study, participants will be randomly assigned (like flipping a coin) to one of four treatment groups during their coronary procedure. The treatments differ in two ways: (1) how the calcified artery is prepared before placing the stent, and (2) how imaging is used to guide stent placement.
One method uses a shockwave-based device to help break calcium in the artery, while the other uses standard balloon treatment. For imaging guidance, one approach uses a high-resolution imaging catheter inside the artery, and the other relies on standard X-ray imaging. All participants will receive a standard, approved drug-eluting stent as part of routine care.
The main goal of the study is to determine which treatment approach best reduces serious heart-related problems over three years. These problems include heart-related death, heart attack in the treated vessel, or the need for another procedure on the same vessel.
Adults aged 18 years or older with significant coronary artery narrowing and severe calcium buildup may be eligible to participate. All participants must provide written informed consent before joining the study.
Participants will be followed during their hospital stay and through regular follow-up visits or phone calls for up to three years after the procedure. Information collected during the study will help doctors better understand how to treat patients with severely calcified coronary arteries in the future.
Participation in this study is voluntary, and patients may withdraw at any time without affecting their medical care. All study devices used in this trial are approved for clinical use, and patient privacy will be protected according to applicable regulations.
Detailed description
LOCATION Study is a prospective, multicenter, 2x2 factorial randomized controlled trial.
Number of Sites: Approximately 50 sites in China.
Trial Objectives:
Objective 1: To evaluate the efficacy and safety of coronary intravascular lithotripsy (IVL) compared with balloon angioplasty (BA) for pretreatment of severely coronary calcified lesions prior to implantation of stents.
Objective 2: To evaluate the efficacy of optical coherence tomography (OCT)-guided compared with angiography-guided stent implantation in severely coronary calcified lesions.
Trial Hypotheses:
Hypotheses 1: IVL pretreatment of severely calcified coronary artery lesions will reduce the 3-year risk of target vessel failure (TVF, a composite of cardiac death, target vessel myocardial infarction [TVMI], or clinically-driven target vessel revascularization [TVR]) compared with BA pretreatment.
Hypotheses 2: OCT-guided percutaneous coronary intervention (PCI) will reduce 3-year risk of TVF compared with angiography-guided PCI in severely coronary calcified lesions.
Trial Population:Patients with one or more angiographically severely calcified coronary lesions
Trial Devices:
IVL device: SoniCrackerTM Coronary IVL Therapy System (Shanghai Bluesail Boyuan Medical Technology co., Ltd) BA Devices: standard commercially approved balloon angioplasty devices including high-pressure balloons, scoring balloons, and cutting balloons, without brand restriction OCT device: Intravascular Imaging System (Nanjing Forssmann Medical Technology Co., Ltd)
Follow-up Visits:
Follow-up will range between 1-year minimum and 3-year maximum. Follow-up will be conducted at discharge, at 30 (±7) days, 180 (±7) days, at 1 year (±30 days), 2 years (±30 days), at 3 (±30 days) years with clinic visit or phone calls. When the last patient reaches 1 year follow-up, an additional "sweep visit" will be performed in all patients who have not had follow-up within 30 days. Additional visits will not be performed after this sweep visit.
Duration:The period of this trial is expected to be approximately 4 years.
Sample size Calculation:
This trial is expected to enroll 3,060 patients, and the sample size calculation is based on the cumulative incidence of TVF as the primary endpoint.
For Hypothesis 1: We expect that the rate of TVF in the BA group will be 7.0%, 12.5%, 16.0% at 1-year, 2-year, and 3-year follow-up, respectively. Assuming a 25% risk reduction, (i.e. the hazard ratio (HR) between the IVL group and the BA group is 0.75), it is estimated that the rate of TVF in the IVL group will be 5.3%, 9.4%, and 12.0% at 1-year, 2-year, and 3-year follow-up, respectively. The subject enrollment period is expected to be 3 years, with annual enrollment rates of 30%, 40%, and 30% respectively. Accounting for a 5% dropout rate in both groups, 3,060 total randomized patients provide 80% power to reject the null hypothesis at a two-sided α level of 0.05.
For Hypothesis 2: We expected that the rate of TVF in the angiography-guided group will be 7.7%, 13.8%, 17.6% at 1-year, 2-year, and 3-year follow-up, respectively. Assuming a 27% risk reduction (i.e. the HR between the OCT-guided group and the angiography-guided group is 0.73), the rate of TVF in the OCT-guided group will be 5.6%, 10.1%, and 12.9% at 1-year, 2-year, and 3-year follow-up, respectively. The subject enrollment period is expected to be 3 years, with annual enrollment rates of 30%, 40%, and 30% respectively. Accounting for a 5% dropout rate in both groups, 2,326 total randomized patients provide 80% power to reject the null hypothesis at a two-sided α level of 0.05. With 3,060 total subjects, 89.6% power is present to reject the null hypothesis.
No interaction between hypotheses 1 and 2 are expected; that is, the benefit of OCT guidance is expected to accrue to a similar degree after both IVL and BA pre-treatment of severely calcified lesions; as such, adjustment for multiplicity is not required. Thus, a total enrollment of 3,060 subjects is planned, with 1530 subjects in each group (IVL vs. BA vessel preparation, and OCT vs. angiography guidance).
Background:
Coronary artery disease (CAD) is a major cardiovascular disorder that imposes a substantial burden on global health. Percutaneous coronary intervention (PCI), as an effective therapeutic strategy for CAD, has been increasingly utilized in clinical practice. With the aging of the population, the proportion and severity of coronary artery calcified lesions have shown a progressive increase. Severely calcified lesions represent one of the most prevalent complex lesion subtypes in CAD that significantly increases the technical difficulty of coronary intervention and thus poses a major challenge to cardiovascular interventional physicians. Notably, patients with calcified lesions have a significantly higher incidence of perioperative complications and long-term major adverse cardiovascular events (MACE). [1] For the pretreatment of calcified lesions, specialized balloons are typically employed, including high-pressure non-compliant balloons, cutting balloons and scoring balloons, as well as coronary atherectomy. However, these approaches have certain limitations. For instance, coronary atherectomy modifies lesion compliance and enlarges the lumen through the ablation of calcified plaques; yet, it may increase the risk of distal embolization, which can result in slow flow or no-reflow. Additionally, its complexity impedes its widespread adoption. Meanwhile, cutting balloons and scoring balloons have not been proven to enhance clinical outcomes in severe calcification.
Coronary intravascular lithotripsy (IVL) is derived from urological lithotripsy techniques. The IVL system consists of miniaturized, arrayed lithotripsy emitters enclosed within a balloon that generate a localized field effect at calcified sites, thereby optimizing energy delivery for the treatment of coronary calcification. This process modifies vascular compliance while preserving the integrity of the native fibroelastic components of the vessel wall, thus reducing vascular injury. The DISRUPT CAD I trial (NCT02650128) [2], the first study investigating IVL, enrolled 60 patients and demonstrated a 98% device success rate for IVL. Following IVL, all patients underwent successful drug-eluting stent (DES) implantation. Subsequently, a series of prospective, multicenter studies have been conducted, including DISRUPT CAD II (NCT03328949) [3], DISRUPT CAD III (NCT03595176) [4-5], and Disrupt CAD IV (NCT04151628) [6-7]. These studies have demonstrated the efficacy and safety of IVL in the management of severe coronary calcified lesions.
The SoniCrackerTM Coronary Intravascular Lithotripsy Therapy System is an IVL product developed by Shanghai Bluesail Boyuan Medical Technology co., Ltd. The device has completed a prospective, multicenter, single-arm pre-market clinical study, enrolling a total of 184 patients with severe coronary artery calcification in China, which showed a procedural success rate of 96.7% (defined as a residual in-stent stenosis ≤30% following stent implantation and without in-hospital major adverse cardiac events). Angiographic success (defined as residual in-stent stenosis ≤30% following stent implantation and without serious angiographic complications) and device success (defined as the IVL catheter successfully crossing the target lesion and delivering lithotripsy without serious angiographic complications) rates were both 100%, with no cases of post-stent residual stenosis >30% or severe angiographic complications. No intraoperative MACE occurred, and the postoperative 6-month MACE rate was 4.9%. The target lesion failure (TLF) rates at 1 month and 6 months post-procedure were 3.3% and 4.4%, respectively. Optical coherence tomography (OCT) subgroup analysis showed immediate post-procedure minimum stent area of 5.30±1.74 mm², minimum stent lumen diameter of 2.56±0.42 mm, immediate lumen gain diameter of 0.98±0.57 mm, and immediate lumen gain area of 3.29±1.45 mm² (data not published). The trial confirmed the device's favorable safety and efficacy. However, there is currently a lack of randomized controlled clinical trial data comparing IVL technology with other calcified lesion management strategies to further validate the superiority of IVL.
Current guidelines recommend the use of intravascular imaging guidance during PCI for complex coronary lesions (especially left main, true bifurcation, and long lesions). However, there remains a lack of intravascular imaging-guided studies with sufficient statistical power to confirm its efficacy in severely calcified lesions. Common clinical intravascular imaging modalities primarily include intravascular ultrasound (IVUS) and OCT. Compared to IVUS, OCT offers distinct advantages in evaluating calcified lesions: it can precisely assess calcification thickness and more accurately quantify the volume of calcified lesions, which is of great significance for determining optimal treatment strategies. Therefore, this trial is designed to evaluate the clinical benefits of OCT-guided stent implantation specifically in severe coronary calcified lesions.
The present clinical trial will employ the SoniCracker™ Coronary Intravascular Lithotripsy Therapy System and Intravascular Imaging System (Nanjing Forssmann Medical Technology Co., Ltd) to further evaluate two key aspects: first, the efficacy and safety of IVL using the SoniCracker™ system versus balloon angioplasty as pretreatment for severely coronary calcified lesions prior to stent implantation; second, the efficacy and safety of OCT-guided versus angiography-guided stent implantation in severely coronary calcified lesions.
Analysis of Potential Benefits
The devices used in the trial have demonstrated safety and efficacy in pre-market clinical trials and has obtained marketing approval from the China National Medical Products Administration (NMPA). Potential benefits include: achieving immediate procedural success, adequate stent expansion, reducing intraoperative complications, improving long-term vascular patency, and clinical outcomes, etc. Participation in this trial is purely voluntary, and enrolled subjects will not receive direct additional benefits. However, information collected from this trial may help deepen the understanding of clinical outcomes in percutaneous coronary intervention (PCI). Ultimately, this knowledge may provide physicians with more information to help improve the treatment of future patients.
Data Management System
The data collection/management system for this trial is an EDC (Electronic Data Capture) system. This is a validated electronic data capture system with audit trial management and user permission management capabilities.
Source data verification is performed to ensure the accuracy and completeness of key study variables. Protocol deviations, adverse events, and serious adverse events are documented and reported according to the study protocol and applicable regulatory and local regulatory requirements.
General Principles
Continuous variables will be summarized as the number of observations, number of missing values, mean, standard deviation, median, quartiles, and range. Categorical variables will be summarized as the number of observations, number of missing values, frequencies, and percentages. Baseline clinical, demographic, laboratory and procedural characteristics will be summarized by randomized treatment group.
All statistical analyses will be performed using SAS software, Version 9.4 or greater. For comparison between the two groups, all hypothesis tests are conducted by two-sided test, α=0.05. The efficacy analysis will be conducted according to the intention-to-treat (ITT) principle. Kaplan-Meier curves and log-rank test will be used to analyze and compare the timing of the first event in each group. P <0.05 is statistically significant. The reliability of all 2-sided confidence intervals (CI) is 95%, and Cox proportional risk regression model is used to determine the hazard ratio (HR).
Ethical Considerations
The study is conducted in compliance with the Declaration of Helsinki, applicable regulatory requirements, and approvals from institutional review boards or ethics committees at each participating site. All participants provide written informed consent prior to enrollment. Participant confidentiality is maintained throughout the study.
The Clinical Events Committee (CEC) will be established for this study.The Crossover Device Evaluation Committee will be established to provide impartial assessment of crossover subjects.The imaging core lab(s) will provide central reading/analysis for angiographic and OCT images generated pre-procedure,during the procedure, and post-procedure at enrolling sites.
Data Safety Monitoring Board (DSMB)
A Data Safety Monitoring Board will be established for this clinical trial to assess, at intervals during the trial, the data and to recommend to the Steering Committee whether to continue, suspend, modify, or terminate the trial early. The DSMB will consist of a minimum of three (3) members, one of which will be a statistician. The DSMB will not be affiliated with the Sponsor or its members will not be actively participating in the trial. Details of the DSMB's composition, specific review processes, and operating procedures are outlined in its charter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- The LOCATION study adopts a prospective, multicenter, 2×2 factorial randomized controlled model for severe coronary calcified lesions. Key details: 1. Randomization: 3,060 patients are 1:1 randomized to IVL/BA pretreatment and 1:1 to OCT/angiography guidance (4 parallel groups), stratified by site and diabetes with block sizes 2/4/6 via IWRS. 2. Interventions: IVL (SoniCracker™) vs standard BA for lesion prep; OCT (Nanjing Forssmann) vs angiography for stent guidance. 3. Crossover Rules: BA→IVL prohibited; IVL→other devices allowed only for specific criteria (recorded as failure). 4. Blinding: Open-label for investigators/subjects; core lab and CEC adjudicate outcomes blindly. 5. Follow-up: 30 days, 6 months, 1/2/3 years + sweep visit; primary endpoint is 3-year TVF. 6. Analysis Sets: ITT (efficacy), PP (sensitivity), SS (safety).
| Arm | Type | Receives |
|---|---|---|
| IVL pre-treatment plus OCT-guided group | Experimental | Device: IVL Pretreatment + OCT-Guided Stent Implantation(1st OCT) perform OCT after the small balloon pre-dilatation but before the IVL; then IVL is performed* followed by the 1:1 high-pressure balloon pre-dilatation followed by the 2nd OCT; then implant the DES and perform post-dilatation with a high-pressure balloon at ≥18 atm (mandatory); then perform the final OCT (3rd OCT). Assess the stent to determine if further PCI is required to optimize stent implantation - either maximize stent expansion or treat malapposition, tissue protrusion, a major edge dissection or untreated reference segment disease. If further stent optimization is required, do so, after which a final OCT run must be performed again (4th OCT). Note: If IVL is unable to cross or dilate the lesion, rotational atherectomy, orbital atherectomy, or excimer laser should be performed followed by IVL. OCT must still be performed prior to stenting. Investigators should use IVL in accordance with the device's instructions for use. |
| IVL pre-treatment plus angiography-guided group | Active comparator | Device: IVL Pretreatment + Angiography-Guided Stent ImplantationAn attempt should be made to cross the target lesion with the IVL catheter after the 1.5 mm or 2.0 mm balloon dilation. If the IVL will not cross the lesion, a larger balloon or atherectomy may be used - then IVL must be performed*. Following successful IVL, pre-dilatation must be performed and be successful (complete balloon expansion) with a high-pressure balloon sized 1:1 to the distal reference segment prior to stenting (mandatory); then one or more stents are implanted (DES only); then post-dilatation must be performed with a high-pressure balloon at ≥18 atm (mandatory). A final OCT run blinded to the operator is then performed as the last procedure. NOTE: Investigators should use IVL in accordance with the device's instructions for use. |
| balloon angioplasty pre-treatment plus OCT-guided group | Active comparator | Device: Balloon Angioplasty (BA) Pretreatment + OCT-Guided Stent Implantation(1st OCT) perform baseline OCT after the 1.5 or 2.0 mm balloon; then perform balloon pre-dilatation with a high-pressure balloon sized 1:1 to the distal RVD*; then perform OCT again (2nd OCT); then implant the DES and perform post-dilatation with a high-pressure balloon at ≥18 atm (mandatory); then perform the final OCT (3rd OCT). Assess the stent to determine if further PCI is required to optimize stent implantation - either maximize stent expansion or treat malapposition, tissue protrusion, a major edge dissection or untreated reference segment disease. If further stent optimization is required, do so, after which a final OCT run must be performed again (4th OCT). |
| balloon angioplasty pre-treatment plus angiography-guided group | Active comparator | Device: Balloon Angioplasty (BA) Pretreatment + Angiography-Guided Stent Implantationpre-dilatation must be successful (complete balloon expansion) with a high-pressure balloon (or scoring balloon, cutting balloon, etc.) sized 1:1 to the distal reference segment (mandatory)*; then one or more stents are implanted (DES only); then post-dilatation must be performed with a high-pressure balloon at ≥18 atm (mandatory). *Note: if the 1:1 pre-dilatation balloon is unable to be fully expanded, rotational atherectomy, orbital atherectomy, or excimer laser may be performed. Crossover to IVL is not allowed. After atherectomy or excimer laser, the lesion must again be successfully pre-dilated (complete balloon expansion) with a high-pressure balloon sized 1:1 to the distal reference segment (mandatory) prior to stenting. A final OCT run blinded to the operator is then performed as the last procedure; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Clinical Inclusion criteria:
- Angiographic inclusion criteria：
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- 3.The target lesion has fluoroscopic evidence of severe calcium at the lesion site, defined via angiogram as fluoroscopic radiopacities noted without cardiac motion before contrast injection involving both sides of the arterial wall in at least 1 location and total length of calcium of at least 15 mm; All lesions in the non-target vessel, if any, that require treatment are successfully treated without complications prior to randomization, defined as final diameter stenosis ≤20% with final TIMI-3 flow, with no residual dissection grade ≥type B, and no transient or sustained angiographic complications (e.g. distal embolization, side branch closure), no chest pain lasting >5 minutes, and no ST-segment elevation or depression lasting >5 minutes.
Key exclusion criteria (22 listed)
- Clinical exclusion criteria：
- <!-- -->
- Angiographic Exclusion Criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVL Pretreatment + OCT-Guided Stent ImplantationSubjects who have signed ICF and have met all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 to IVL vessel preparation strategy or balloon angioplasty vessel preparation strategy. Concurrently, subjects will randomly be assigned in a 1:1 ratio to receive OCT-guidance or angiographic-guidance of the PCI procedure. Subject randomization in each of the 4 groups will be stratified by site and diabetes in varying block sizes of 2, 4 or 6. Randomization will be conducted with the use of an interactive web response system (IWRS). | Device | IVL pre-treatment plus OCT-guided group |
| IVL Pretreatment + Angiography-Guided Stent ImplantationSubjects who have signed ICF and have met all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 to IVL vessel preparation strategy or balloon angioplasty vessel preparation strategy. Concurrently, subjects will randomly be assigned in a 1:1 ratio to receive OCT-guidance or angiographic-guidance of the PCI procedure. Subject randomization in each of the 4 groups will be stratified by site and diabetes in varying block sizes of 2, 4 or 6. Randomization will be conducted with the use of an interactive web response system (IWRS). | Device | IVL pre-treatment plus angiography-guided group |
| Balloon Angioplasty (BA) Pretreatment + OCT-Guided Stent ImplantationSubjects who have signed ICF and have met all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 to IVL vessel preparation strategy or balloon angioplasty vessel preparation strategy. Concurrently, subjects will randomly be assigned in a 1:1 ratio to receive OCT-guidance or angiographic-guidance of the PCI procedure. Subject randomization in each of the 4 groups will be stratified by site and diabetes in varying block sizes of 2, 4 or 6. Randomization will be conducted with the use of an interactive web response system (IWRS). | Device | balloon angioplasty pre-treatment plus OCT-guided group |
| Balloon Angioplasty (BA) Pretreatment + Angiography-Guided Stent ImplantationSubjects who have signed ICF and have met all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 to IVL vessel preparation strategy or balloon angioplasty vessel preparation strategy. Concurrently, subjects will randomly be assigned in a 1:1 ratio to receive OCT-guidance or angiographic-guidance of the PCI procedure. Subject randomization in each of the 4 groups will be stratified by site and diabetes in varying block sizes of 2, 4 or 6. Randomization will be conducted with the use of an interactive web response system (IWRS). | Device | balloon angioplasty pre-treatment plus angiography-guided group |
Primary outcome
Target Vessel Failure (TVF) at 3 years
Time frame: 3 years
Composite time-to-first event rate of cardiac death, target vessel myocardial infarction (TV-MI), or ischemia-driven target vessel revascularization (iTVR) at 3 years, assessed when the last enrolled patient reaches 1-year follow-up
27 secondary outcomes
TVF （Target Vessel Failure ）(at 1 and 2 years)
Time frame: 1 and 2 years
Target Lesion Failure (TLF)
Time frame: 30 days, 6 months ,1 year, 2 years, and 3 years
Major Adverse Cardiovascular Events (MACE)
Time frame: 30 days, 6 months,1 year, 2 years, and 3 years
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time frame: 30 days, 6 months,1 year, 2 years, and 3 years
Cardiac death
Time frame: 30 days, 6 months,1 year, 2 years, and 3 years
Incidence of stent thrombosis
Time frame: 30 days, 6 months,1 year, 2 years, and 3 years
Severe angiographic complications
Time frame: Immediate post-procedure
Procedural strategy success
Time frame: Immediate post-procedure
Post-procedural minimum stent area (MSA) at the site of maximum calcification and across the entire target lesion;
Time frame: Immediate post-procedure
Post-procedural mean stent area
Time frame: Immediate post-procedure
Post-procedural minimum lumen diameter (MLD)
Time frame: Immediate post-procedure
Minimum stent expansion
Time frame: Immediate post-procedure
Stent malposition
Time frame: Immediate post-procedure
Number of calcification fractures
Time frame: Immediate post-procedure
Major and minor edge dissection
Time frame: Immediate post-procedure
Major and minor tissue protrusion
Time frame: Immediate post-procedure
Incidence of Untreated reference segment disease
Time frame: Immediate post-procedure
Target vessel myocardial infarction (TV-MI)
Time frame: 30 days, 6 months,1 year, 2 years, and 3 years
ischemia-driven target vessel revascularization (iTVR)
Time frame: 30 days, 6 months,1 year, 2 years, and 3 years
MI （Myocardial Infarction）
Time frame: 30 days, 6 months,1 year, 2 years, and 3 years
all-cause death
Time frame: 30 days, 6 months,1 year, 2 years, and 3 years
Stoke
Time frame: 30 days, 6 months,1 year, 2 years, and 3 years
any revascularization
Time frame: 30 days, 6 months,1 year, 2 years, and 3 years
Post-procedural mean lumen diameter(LD)
Time frame: Immediate post-procedure
Mean stent expansion
Time frame: Immediate post-procedure
Thickness (full-layer or partial) of calcification （mm)
Time frame: Immediate post-procedure
Depth of calcification fractures(mm）
Time frame: Immediate post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Results publication[16] Han Y, Jing Q, Liu H, et al. A novel coronary intravascular Lithotripsy device in patients with severely calcified lesions: LEAD-FIM study. Presented at EuroPCR 2024.
- Results publication: PubMed 40174596Kirtane AJ, Genereux P, Lewis B, Shlofmitz RA, Dohad S, Choudary J, Dahle T, Pineda AM, Shunk K, Maehara A, Popma A, Redfors B, Ali ZA, Krucoff M, Armstrong E, Kandzari DE, O'Neill W, Kraemer C, Stiefel KM, Jones DE, Chambers J, Stone GW; ECLIPSE Investigators. Orbital atherectomy versus balloon angioplasty before drug-eluting stent implantation in severely calcified lesions eligible for both treatment strategies (ECLIPSE): a multicentre, open-label, randomised trial. Lancet. 2025 Apr 12;405(10486):1240-1251. doi: 10.1016/S0140-6736(25)00450-7. Epub 2025 Mar 30.
- Results publication: PubMed 24135581Moussa ID, Klein LW, Shah B, Mehran R, Mack MJ, Brilakis ES, Reilly JP, Zoghbi G, Holper E, Stone GW. Consideration of a new definition of clinically relevant myocardial infarction after coronary revascularization: an expert consensus document from the Society for Cardiovascular Angiography and Interventions (SCAI). J Am Coll Cardiol. 2013 Oct 22;62(17):1563-70. doi: 10.1016/j.jacc.2013.08.720.
- Results publication: PubMed 37012181Blachutzik F, Meier S, Weissner M, Schlattner S, Gori T, Ullrich-Daub H, Gaede L, Achenbach S, Mollmann H, Chitic B, Aksoy A, Nickenig G, Weferling M, Dorr O, Boeder N, Bayer M, Elsasser A, Hamm C, Nef H; ROTA.Shock Investigators. Comparison of Coronary Intravascular Lithotripsy and Rotational Atherectomy in the Modification of Severely Calcified Stenoses. Am J Cardiol. 2023 Jun 15;197:93-100. doi: 10.1016/j.amjcard.2023.02.028. Epub 2023 Apr 2.
- Results publication: PubMed 36336588Mousa MAA, Bingen BO, Al Amri I, Mertens BJA, Taha S, Tohamy A, Youssef A, Jukema JW, Montero-Cabezas JM. Efficacy and Safety of Intravascular Lithotripsy Versus Rotational Atherectomy in Balloon-Crossable Heavily Calcified Coronary Lesions. Cardiovasc Revasc Med. 2023 Mar;48:1-6. doi: 10.1016/j.carrev.2022.10.011. Epub 2022 Oct 29. No abstract available.
- Results publication: PubMed 36075883Cubero-Gallego H, Calvo-Fernandez A, Tizon-Marcos H, Aparisi A, Gomez-Lara J, Amat-Santos I, Fuertes M, Santos-Martinez S, Salvatella N, Garcia-Guimaraes M, Negrete A, Mohandes M, Gomez-Hospital JA, Moris C, Vaquerizo B. Real-World Multicenter Coronary Lithotripsy Registry: Long-Term Clinical Follow-Up. J Invasive Cardiol. 2022 Oct;34(10):E701-E708. doi: 10.25270/jic/22.00058. Epub 2022 Aug 30.
- Results publication: PubMed 30765621Wong B, El-Jack S, Newcombe R, Glenie T, Armstrong G, Khan A. Shockwave Intravascular Lithotripsy for Calcified Coronary Lesions: First Real-World Experience. J Invasive Cardiol. 2019 Mar;31(3):46-48. doi: 10.25270/jic/19.00048. Epub 2019 Feb 15.
- Results publication: PubMed 38385926Rodriguez-Leor O, Cid-Alvarez AB, Lopez-Benito M, Gonzalo N, Vilalta V, Diarte de Miguel JA, Lopez LF, Jurado-Roman A, Diego A, Oteo JF, Cuellas C, Trillo R, Travieso A, Alfonso F, Carrillo X, Vegas-Valle JM, Cortes-Villar C, Pascual I, Munoz Camacho JF, Flores X, Vera-Vera S, Moreu J, Barreira de Sousa G, Marti D, Jimenez-Mazuecos J, Fuertes M, Ocaranza R, de la Torre Hernandez JM, Lozano F, Solana Martinez SG, Gomez-Lara J, Perez de Prado A; REPLICA-EPIC18 Investigators. A Prospective, Multicenter, Real-World Registry of Coronary Lithotripsy in Calcified Coronary Arteries: The REPLICA-EPIC18 Study. JACC Cardiovasc Interv. 2024 Mar 25;17(6):756-767. doi: 10.1016/j.jcin.2023.12.018. Epub 2024 Feb 21.
- Results publication: PubMed 36875163Tian F, Zhou SS, Liu JH, Chen H, Sun ZJ, Chen L, Wang Q, Jing J, Chen YD. Treatment of severely calcified coronary artery disease by intravascular lithotripsy primary outcomes and 180-day follow-up from the Chinese SOLSTICE Trial. J Geriatr Cardiol. 2023 Jan 28;20(1):32-39. doi: 10.26599/1671-5411.2023.01.005.
- Results publication: PubMed 33069849Hill JM, Kereiakes DJ, Shlofmitz RA, Klein AJ, Riley RF, Price MJ, Herrmann HC, Bachinsky W, Waksman R, Stone GW; Disrupt CAD III Investigators. Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease. J Am Coll Cardiol. 2020 Dec 1;76(22):2635-2646. doi: 10.1016/j.jacc.2020.09.603. Epub 2020 Oct 15.
- Results publication: PubMed 33551398Saito S, Yamazaki S, Takahashi A, Namiki A, Kawasaki T, Otsuji S, Nakamura S, Shibata Y; Disrupt CAD IV Investigators. Intravascular Lithotripsy for Vessel Preparation in Severely Calcified Coronary Arteries Prior to Stent Placement - Primary Outcomes From the Japanese Disrupt CAD IV Study. Circ J. 2021 May 25;85(6):826-833. doi: 10.1253/circj.CJ-20-1174. Epub 2021 Feb 5.
- Results publication: PubMed 32470635Kereiakes DJ, Hill JM, Ben-Yehuda O, Maehara A, Alexander B, Stone GW. Evaluation of safety and efficacy of coronary intravascular lithotripsy for treatment of severely calcified coronary stenoses: Design and rationale for the Disrupt CAD III trial. Am Heart J. 2020 Jul;225:10-18. doi: 10.1016/j.ahj.2020.04.005. Epub 2020 Apr 18.
- Individual participant dataSharing planned: No. This study has no plan to share de-identified individual participant data (IPD) with researchers outside the primary study team. The reasons for this decision are as follows: Informed Consent \& Ethical Commitment: The informed consent documents for this study do not include provisions for IPD sharing, as participants only consented to data use for the original analysis of this study. This approach has been reviewed and approved by the Institutional Review Board/Ethics Committee (IRB/IEC) to uphold ethical commitments and avoid using data beyond the scope of participant understanding.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yaling Han principal investigator
The General Hospital of Northern Theater Command
Gregg W. Stone study chair
Icahn School of Medicine at Mount Sinai, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVL Pretreatment + OCT-Guided Stent Implantation, IVL Pretreatment + Angiography-Guided Stent Implantation and Balloon Angioplasty (BA) Pretreatment + OCT-Guided Stent Implantation in people with Coronary Artery Disease and Severe Coronary Artery Disease, run by Shanghai Bluesail Boyuan Medical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuanchun Sun (+8613683382436, yuc.sun@jwmsgrp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Vessel Failure (TVF) at 3 years (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07388030, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.