Calcified AtheromaNCT05732025
Evaluation of Safety and Effectiveness of the SONICO-CX Intracoronary Electrohydraulic Shockwave Balloon Catheter
A study testing Electrohydraulic shock wave lithotripsy and Rotary atherectomy in people with Calcified Atheroma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
Calcified coronary lesions often run through various complex lesions, which increases the difficulty of coronary intervention, is one of the main challenges faced by interventional cardiovascular physicians. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calcified Atheroma
- What is being tested?
- Electrohydraulic shock wave lithotripsy and Rotary atherectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- May 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Criteria:
- Age ≥ 18 years old
- Evidence of asymptomatic ischemia, stable or unstable angina
- Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent, and are willing to accept angiography, OCT examination and clinical follow-up.
- Angiographic Criteria:
- The target lesion is primary and in situ coronary artery lesion
Show all 12Show fewer
- The length of the target lesion is ≤60mm, and the diameter of the target lesion is 2.5-4.0mm (visually)
- The stenosis rate of the target lesion diameter is ≥70%, and the doctor judges that it is necessary to implant a stent (visual inspection method) to meet one of the following:
- Diameter stenosis ≥ 70%, < 100%
- ≥50%, <70% with evidence of ischemia
- The lesion allows a 0.014 guidewire to pass
- Under multi-angle imaging conditions, calcified shadow lesions can be seen on both sides of the lesion vessel wall (the target lesion meets the definition of severe calcification)
Who cannot join
- Clinical Criteria:
- Acute myocardial infarction occurred within 30 days before operation
- Use special balloons (chocolate balloons, scored balloons, spinous balloons, etc.) to treat lesions at the same time
- Troponin is greater than 5 times the upper limit of laboratory normal value within one week before operation
- Severe cardiac dysfunction (grade III or IV)
- Left ventricular ejection fraction <25%
Show all 33Show fewer
- The patient refuses emergency CABG surgery or does not have indications for emergency CABG surgery
- Severe uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg)
- Severe renal failure (serum creatinine > 221 μmol/L)
- Preoperative hemoglobin <100g/L
- Obvious coagulation dysfunction (platelet count<100×109/L or INR>1.7, INR is only required for patients who have taken warfarin orally within 2 weeks before enrollment)
- Blood hypercoagulability diseases (such as polycythemia vera, platelet count >750×109/L, etc.)
- History of stroke or TIA within 3 months
- History of active peptic ulcer or upper gastrointestinal bleeding within 6 months
- The life expectancy of the patient is less than 12 months
- The patient has an active systemic infection
- The patient has a connective tissue disorder (such as Marfan syndrome)
- Patient is allergic to contrast material
- Patients undergoing heart transplantation
- Patients with implanted cardiac pacemakers
- The patient is pregnant or breastfeeding
- Those who have participated in clinical trials of other drugs or medical devices within one month before enrollment;
- Other circumstances that the investigator considers inappropriate to participate in the trial
- Angiographic Criteria:
- Unprotected left main lesion (left main visual stenosis >50%)
- Baseline TIMI blood flow is less than grade 3 (evaluation after pre-dilation is allowed)
- A stent has been implanted within 10mm of the proximal or distal end of the target lesion
- The target lesion is located distal to the saphenous vein or LIMA/RIMA bypass graft
- Aneurysm in the target vessel
- Angiography confirmed the presence of thrombus in the target vessel
- Chronic total occlusive disease
- Angiography confirmed the presence of severe dissection of the target lesion before hydroelectric shock wave lithotripsy (D-F type dissection (NHLBI classification)
- The investigator judged that the target lesion is not suitable for patients with vasodilation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Safety and Effectiveness of the SONICO-CX Intracoronary Electrohydraulic Shockwave Balloon Catheter/Hydraulic Shock Wave Lithotripsy, A Prospective, Single-center, Randomized Controlled Exploratory Clinical Study
Calcified coronary lesions often run through various complex lesions, which increases the difficulty of coronary intervention, is one of the main challenges faced by interventional cardiovascular physicians. Severely calcified lesions, or severely calcified lesions with twisted, angulated, diffused, significantly increase rates of immediate complications and early and late major adverse cardiovascular events. Correctly identifying and evaluating calcified lesions, and selecting the most appropriate treatment strategy according to the degree of coronary artery calcification are very important for improving the success rate of intervention, reducing complications, and improving the short-term and long-term prognosis of patients.
Read the detailed description
Calcified coronary lesions often run through various complex lesions, which increases the difficulty of coronary intervention, is one of the main challenges faced by interventional cardiovascular physicians. Severely calcified lesions, or severely calcified lesions with twisted, angulated, diffused, significantly increase rates of immediate complications and early and late major adverse cardiovascular events. Correctly identifying and evaluating calcified lesions, and selecting the most appropriate treatment strategy according to the degree of coronary artery calcification are very important for improving the success rate of intervention, reducing complications, and improving the short-term and long-term prognosis of patients.The current regular interventional treatment methods for coronary calcification lesions include plain balloons, non-compliant balloons, cutting balloons, etc., but the incidence of complications is high and the rate of long-term restenosis is high, and the effect is not satisfactory. Rotary atherectomy is currently the main pretreatment method for severe calcified lesions. Rotary atherectomy combined with drug-eluting stent implantation has become an important mean for the treatment of severe calcified lesions, even complex lesions, in the DES era, and has good safety and effectiveness. However, this technique is more complicated, and in order to ensure its advantages, it needs correct and meticulous operation by an experienced interventional team. Studies have shown that the use rate of rotational atherectomy in high-capacity centers is only 3% to 5%. The reasons may be related to the expensive equipment, difficult operation and unfamiliarity with new technologies. The intra-coronary electrohydraulic shock wave balloon catheter is a device that combines electrohydraulic shock wave lithotripsy with percutaneous transluminal angioplasty. After the catheter is connected to the device and energized, the micro-transmitter installed in the balloon can generate pulsed sound pressure waves to shatter the calcified plaque inside the target lesion, enabling subsequent expansion of the lesion at low pressure. SONICO-CX intracoronary electrohydraulic shock wave balloon catheter is a new type of plaque remodeling device, which can not only change the compliance of the artery, but also reduce the damage of the vessel wall. It provides a new option for doctors to better solve the problem of severe calcified lesions, and also brings more benefits to patients. This randomized trial was conducted to assess the efficacy/safety of intracoronary electrohydraulic shock wave lithotripsy versus rotational atherectomy based on optical coherence tomography (OCT) measurements.
- Conditions
- Calcified Atheroma
- Being tested
- Electrohydraulic shock wave lithotripsy, Rotary atherectomy
- Keywords
- Calcified coronary lesions, Rotary atherectomy, Electrohydraulic shock wave lithotripsy, Optical coherence tomography (OCT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrohydraulic shock wave lithotripsyDevice
Pre-treatment of severe calcified coronary lesions with electrohydraulic shock wave lithotripsy
Rotary atherectomyDevice
Pre-treatment of severe calcified coronary lesions with rotary atherectomy
| Study group | Role | What they receive |
|---|---|---|
| Electrohydraulic shock wave lithotripsy | Experimental | Pre-treatment of severe calcified coronary lesions with electrohydraulic shock wave lithotripsy Receives: Device: Electrohydraulic shock wave lithotripsy |
| Rotary atherectomy | Active comparator | Pre-treatment of severe calcified coronary lesions with Rotary atherectomy Receives: Device: Rotary atherectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent expansion rate using OCT
Stent expansion rate=Minimum lumen area in the stent/(distal reference vessel area + proximal reference vessel area)*1/2
Measured: Immediately after surgery
Secondary outcomes (8)
Angiography success rate
Measured: Immediately after surgery
Minimum stent area (MSA) immediately after surgery
Measured: Immediately after surgery
Minimum lumen diameter MLD immediately after operation
Measured: Immediately after surgery
The diameter of the lumen immediately after operation
Measured: Immediately after surgery
Obtained lumen area immediately after operation
Measured: Immediately after surgery
Lumen acquisition rate immediately after operation
Measured: Immediately after surgery
Incomplete apposition rate of stent
Measured: Immediately after surgery
Symmetry of the expansion of stent
Measured: Immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study startMay 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcified AtheromaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian-an Wang, MD,PhD, Principal investigator, Second Affiliated Hospital of Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732025
- Sponsor's protocol ID
- SAHZJU CT020
- Status last verified
- Jul 2022
- First submitted
- 7 Feb 2023
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Effectiveness of the SONICO-CX Intracoronary Electrohydraulic Shockwave Balloon Catheter/Hydraulic Shock Wave Lithotripsy, A Prospective, Single-center, Randomized Controlled Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT05732025
- Acronym / sponsor ID
- SAHZJU CT020
- Conditions
- Calcified Atheroma
- Keywords
- Calcified coronary lesions, Rotary atherectomy, Electrohydraulic shock wave lithotripsy, Optical coherence tomography (OCT)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 16 Feb 2023 (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.
Calcified coronary lesions often run through various complex lesions, which increases the difficulty of coronary intervention, is one of the main challenges faced by interventional cardiovascular physicians. Severely calcified lesions, or severely calcified lesions with twisted, angulated, diffused, significantly increase rates of immediate complications and early and late major adverse cardiovascular events. Correctly identifying and evaluating calcified lesions, and selecting the most appropriate treatment strategy according to the degree of coronary artery calcification are very important for improving the success rate of intervention, reducing complications, and improving the short-term and long-term prognosis of patients.
Detailed description
Calcified coronary lesions often run through various complex lesions, which increases the difficulty of coronary intervention, is one of the main challenges faced by interventional cardiovascular physicians. Severely calcified lesions, or severely calcified lesions with twisted, angulated, diffused, significantly increase rates of immediate complications and early and late major adverse cardiovascular events. Correctly identifying and evaluating calcified lesions, and selecting the most appropriate treatment strategy according to the degree of coronary artery calcification are very important for improving the success rate of intervention, reducing complications, and improving the short-term and long-term prognosis of patients.The current regular interventional treatment methods for coronary calcification lesions include plain balloons, non-compliant balloons, cutting balloons, etc., but the incidence of complications is high and the rate of long-term restenosis is high, and the effect is not satisfactory. Rotary atherectomy is currently the main pretreatment method for severe calcified lesions. Rotary atherectomy combined with drug-eluting stent implantation has become an important mean for the treatment of severe calcified lesions, even complex lesions, in the DES era, and has good safety and effectiveness. However, this technique is more complicated, and in order to ensure its advantages, it needs correct and meticulous operation by an experienced interventional team. Studies have shown that the use rate of rotational atherectomy in high-capacity centers is only 3% to 5%. The reasons may be related to the expensive equipment, difficult operation and unfamiliarity with new technologies. The intra-coronary electrohydraulic shock wave balloon catheter is a device that combines electrohydraulic shock wave lithotripsy with percutaneous transluminal angioplasty. After the catheter is connected to the device and energized, the micro-transmitter installed in the balloon can generate pulsed sound pressure waves to shatter the calcified plaque inside the target lesion, enabling subsequent expansion of the lesion at low pressure. SONICO-CX intracoronary electrohydraulic shock wave balloon catheter is a new type of plaque remodeling device, which can not only change the compliance of the artery, but also reduce the damage of the vessel wall. It provides a new option for doctors to better solve the problem of severe calcified lesions, and also brings more benefits to patients. This randomized trial was conducted to assess the efficacy/safety of intracoronary electrohydraulic shock wave lithotripsy versus rotational atherectomy based on optical coherence tomography (OCT) measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrohydraulic shock wave lithotripsy | Experimental | Device: Electrohydraulic shock wave lithotripsyPre-treatment of severe calcified coronary lesions with electrohydraulic shock wave lithotripsy |
| Rotary atherectomy | Active comparator | Device: Rotary atherectomyPre-treatment of severe calcified coronary lesions with Rotary atherectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Clinical Criteria:
- Angiographic Criteria:
Key exclusion criteria (33 listed)
- Clinical Criteria:
- Angiographic 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 |
|---|---|---|
| Electrohydraulic shock wave lithotripsyPre-treatment of severe calcified coronary lesions with electrohydraulic shock wave lithotripsy | Device | Electrohydraulic shock wave lithotripsy |
| Rotary atherectomyPre-treatment of severe calcified coronary lesions with rotary atherectomy | Device | Rotary atherectomy |
Primary outcome
Stent expansion rate using OCT
Time frame: Immediately after surgery
Stent expansion rate=Minimum lumen area in the stent/(distal reference vessel area + proximal reference vessel area)*1/2
8 secondary outcomes
Angiography success rate
Time frame: Immediately after surgery
Minimum stent area (MSA) immediately after surgery
Time frame: Immediately after surgery
Minimum lumen diameter MLD immediately after operation
Time frame: Immediately after surgery
The diameter of the lumen immediately after operation
Time frame: Immediately after surgery
Obtained lumen area immediately after operation
Time frame: Immediately after surgery
Lumen acquisition rate immediately after operation
Time frame: Immediately after surgery
Incomplete apposition rate of stent
Time frame: Immediately after surgery
Symmetry of the expansion of stent
Time frame: Immediately after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jian-an Wang, MD,PhD principal investigator
Second Affiliated Hospital of Zhejiang University, School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Electrohydraulic shock wave lithotripsy and Rotary atherectomy in people with Calcified Atheroma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 12 inclusion and 33 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: status not confirmed, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Jiang, MD,PhD (+86-13588706891, Jiang_jun@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent expansion rate using OCT (time frame: Immediately after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2023.