Intravascular LithotripsyNCT06521905
Clinical Trial on the Treatment of Stent Underexpansion Caused by Calcification Using Intravascular Lithotripsy
A study testing intravascular lithotripsy and high-pressure ballon in people with Intravascular Lithotripsy, run by China National Center for Cardiovascular Diseases.
Trial summary
Our aim is to investigate the efficacy and safety of intravascular lithotripsy(IVL) in the treatment of stent underexpansion caused by calcification through a prospective, multicenter, randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intravascular Lithotripsy
- What is being tested?
- intravascular lithotripsy and high-pressure ballon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Oct 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range: 18-80 years old, male or non pregnant female
- The patient or guardian can voluntarily sign and understand the informed consent form, and can accept follow-up
- Asymptomatic ischemic, stable or unstable angina or myocardial infarction (MI) (including ST segment elevation and non ST segment elevation MI) with chest pain onset to hospital admission time>24 hours, as well as old myocardial infarction patients
- Visually assess the target lesion with a reference vessel diameter of 2.5-4.0mm, diameter stenosis degree ≥ 70% or ≥ 50%, and evidence of ischemia
- The target lesion is the only lesion that requires treatment this time
- Patients suitable for percutaneous coronary stent implantation
- Confirmed by coronary angiography or IVUS testing that the target lesion is calcified, with any degree of calcification
- After surgical treatment for calcified lesions, IVUS testing confirmed that it meets the criteria for incomplete stent expansion
Who cannot join
- Individuals with abnormal coagulation function tests
- Patients with severe hemodynamic disorders
- Clinical manifestations of heart failure with LVEF<30%
- I have experienced an acute myocardial infarction in the past week
- Patients allergic to heparin, contrast agents, antiplatelet drugs, anticoagulants, anesthetics, etc
- Patients with severe myocardial bridge/negative remodeling or target vessel thrombosis
Show all 20Show fewer
- Pregnant or lactating women
- Patients with malignant tumors or comorbidities with a life expectancy of less than 12 months
- History of active peptic ulcer or gastrointestinal bleeding within 6 months prior to enrollment
- Stroke occurred within 6 months prior to enrollment, excluding transient ischemic attack (TIA) and cerebral infarction
- Severe liver and kidney function impairment, transaminase levels exceeding the upper limit of normal by more than three times, creatinine levels greater than 2.5mg/dL (221 μ moI/L), or chronic renal failure requiring long-term dialysis
- Anti thrombotic therapy intolerance
- Severe anemia, thrombocytopenia, or leukopenia
- History of severe bleeding (intracranial, gastrointestinal)
- Also participating in other patients who have not completed clinical trials at the same time
- Patients with poor compliance and inability to complete the study on time
- Other situations deemed unsuitable by researchers to participate in this clinical study
- Thrombotic lesion
- Bridge vascular disease
- Angiography shows tortuous vascular pathways, making it difficult for experimental instruments to reach the target position or retrieve them
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective, Multicenter, Randomized Controlled Study on the Treatment of Stent Underexpansion Caused by Calcification Using Intravascular Lithotripsy
Our aim is to investigate the efficacy and safety of intravascular lithotripsy(IVL) in the treatment of stent underexpansion caused by calcification through a prospective, multicenter, randomized controlled trial. Patients with inadequate stent expansion due to calcification detected by intravascular ultrasound(IVUS) were randomly divided into two groups. The experimental group received IVL in addition to high-pressure balloon post-dilation, while the control group only received high-pressure balloon post-dilation. Follow up for 1 year is conducted to determine the safety and efficacy of IVL application based on the primary efficacy endpoint, key secondary efficacy endpoint, other secondary efficacy endpoint, and safety endpoint.
Read the detailed description
In order to investigate the effectiveness and safety of intravascular lithotripsy(IVL) in patients with calcium induced stent insufficiency, we designed a prospective, randomized, controlled, single blind, multicenter, and superior efficacy clinical trial. We include a real-world population of patients who had stent underexpansion due to calcification detected by intravascular ultrasound(IVUS) in the target vessel after percutaneous coronary intervention(PCI) and met the inclusion and exclusion criteria. In addition to routine clinical treatment, IVUS testing was performed on patients after PCI. Patients who met the criteria for stent underexpansion detected by IVUS are randomly divided into two groups. The experimental group received IVL intervention on the basis of high-pressure balloon post-dilation, while the control group received more aggressive high-pressure balloon post-dilation treatment. The satisfaction rate of stent dilation detected by IVUS in both groups after IVL or high-pressure balloon post-dilation was taken as the main efficacy endpoint. MACE events (composed of cardiovascular death, target vessel myocardial infarction and target vascular revascularization) from PCI to one-year follow-up are evaluated. And the acquisition of lumen after treatment is used as other secondary efficacy endpoints. We use postoperative complications such as coronary artery spasm, dissection, acute occlusion, and persistent ventricular arrhythmia as safety endpoints.
- Conditions
- Intravascular Lithotripsy
- Being tested
- intravascular lithotripsy, high-pressure ballon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravascular lithotripsyDevice
The intravascular lithotripsy can intermittently release acoustic pressure waves at the site of vascular calcification lesions, thereby achieving the goal of rupturing calcified plaques; After the rupture of calcified plaques, the vascular calcification lesions can be fully dilated with the help of lower balloon inflation pressure.
high-pressure ballonDevice
High pressure balloon dilation, as the main method for traditional treatment of insufficient stent expansion caused by calcification, has a good therapeutic effect on insufficient stent expansion caused by calcification
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | intravascular lithotripsy is used on the basis of high-pressure balloon dilation Receives: Device: intravascular lithotripsy |
| control group | Active comparator | only use more positive high-pressure ballon dilation Receives: Device: high-pressure ballon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction Rate of Stent Expansion[Effcacy]
Satisfied stent expansion is defined as meeting the standard of good expansion after stent implantation through IVUS after PCI
Measured: immediately after percutaneous coronary intervention(PCI)
Secondary outcomes (3)
Major Cardiovascular Events[Effcacy]
a composite endpoint of cardiovascular death, target vessel myocardial infarction and target vessel revascularization
Measured: 1 year after after percutaneous coronary intervention(PCI)
Lumen Obtainment after PCI[Effcacy]
changes in lumen area after treatment
Measured: immediately after percutaneous coronary intervention(PCI)
Incidence of Treatment-Emergent Complications[Safety]
Postoperative complications such as coronary spasm, dissection, acute occlusion, persistent ventricular arrhythmia, etc
Measured: immediately after percutaneous coronary intervention(PCI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravascular LithotripsyStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kefei Dou, MD, China National Center for Cardiovascular Diseases
- Investigators
- Kefei Dou, Doctor, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521905
- Sponsor's protocol ID
- intravascular lithotripsy
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Except for privacy data, all other data can be made public
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized Controlled Study on the Treatment of Stent Underexpansion Caused by Calcification Using Intravascular Lithotripsy
- ClinicalTrials.gov ID
- NCT06521905
- Acronym / sponsor ID
- intravascular lithotripsy
- Conditions
- Intravascular Lithotripsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 26 Jul 2024 (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.
Our aim is to investigate the efficacy and safety of intravascular lithotripsy(IVL) in the treatment of stent underexpansion caused by calcification through a prospective, multicenter, randomized controlled trial. Patients with inadequate stent expansion due to calcification detected by intravascular ultrasound(IVUS) were randomly divided into two groups. The experimental group received IVL in addition to high-pressure balloon post-dilation, while the control group only received high-pressure balloon post-dilation. Follow up for 1 year is conducted to determine the safety and efficacy of IVL application based on the primary efficacy endpoint, key secondary efficacy endpoint, other secondary efficacy endpoint, and safety endpoint.
Detailed description
In order to investigate the effectiveness and safety of intravascular lithotripsy(IVL) in patients with calcium induced stent insufficiency, we designed a prospective, randomized, controlled, single blind, multicenter, and superior efficacy clinical trial. We include a real-world population of patients who had stent underexpansion due to calcification detected by intravascular ultrasound(IVUS) in the target vessel after percutaneous coronary intervention(PCI) and met the inclusion and exclusion criteria. In addition to routine clinical treatment, IVUS testing was performed on patients after PCI. Patients who met the criteria for stent underexpansion detected by IVUS are randomly divided into two groups. The experimental group received IVL intervention on the basis of high-pressure balloon post-dilation, while the control group received more aggressive high-pressure balloon post-dilation treatment. The satisfaction rate of stent dilation detected by IVUS in both groups after IVL or high-pressure balloon post-dilation was taken as the main efficacy endpoint. MACE events (composed of cardiovascular death, target vessel myocardial infarction and target vascular revascularization) from PCI to one-year follow-up are evaluated. And the acquisition of lumen after treatment is used as other secondary efficacy endpoints. We use postoperative complications such as coronary artery spasm, dissection, acute occlusion, and persistent ventricular arrhythmia as safety endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: intravascular lithotripsyintravascular lithotripsy is used on the basis of high-pressure balloon dilation |
| control group | Active comparator | Device: high-pressure ballononly use more positive high-pressure ballon dilation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age range: 18-80 years old, male or non pregnant female
- The patient or guardian can voluntarily sign and understand the informed consent form, and can accept follow-up
- Asymptomatic ischemic, stable or unstable angina or myocardial infarction (MI) (including ST segment elevation and non ST segment elevation MI) with chest pain onset to hospital admission time>24 hours, as well as old myocardial infarction patients
- Visually assess the target lesion with a reference vessel diameter of 2.5-4.0mm, diameter stenosis degree ≥ 70% or ≥ 50%, and evidence of ischemia
- The target lesion is the only lesion that requires treatment this time
Key exclusion criteria (20 listed)
- Individuals with abnormal coagulation function tests
- Patients with severe hemodynamic disorders
- Clinical manifestations of heart failure with LVEF<30%
- I have experienced an acute myocardial infarction in the past week
- Patients allergic to heparin, contrast agents, antiplatelet drugs, anticoagulants, anesthetics, etc
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 |
|---|---|---|
| intravascular lithotripsyThe intravascular lithotripsy can intermittently release acoustic pressure waves at the site of vascular calcification lesions, thereby achieving the goal of rupturing calcified plaques; After the rupture of calcified plaques, the vascular calcification lesions can be fully dilated with the help of lower balloon inflation pressure. | Device | experimental group |
| high-pressure ballonHigh pressure balloon dilation, as the main method for traditional treatment of insufficient stent expansion caused by calcification, has a good therapeutic effect on insufficient stent expansion caused by calcification | Device | control group |
Primary outcome
Satisfaction Rate of Stent Expansion[Effcacy]
Time frame: immediately after percutaneous coronary intervention(PCI)
Satisfied stent expansion is defined as meeting the standard of good expansion after stent implantation through IVUS after PCI
3 secondary outcomes
Major Cardiovascular Events[Effcacy]
Time frame: 1 year after after percutaneous coronary intervention(PCI)
Lumen Obtainment after PCI[Effcacy]
Time frame: immediately after percutaneous coronary intervention(PCI)
Incidence of Treatment-Emergent Complications[Safety]
Time frame: immediately after percutaneous coronary intervention(PCI)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: No. Except for privacy data, all other data can be made public
Related trials for Intravascular Lithotripsy
Active, not recruiting
Intravascular Lithotripsy in Comparison to Rotational Atherectomy: An Evaluation by OFDI
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Not yet recruiting
Intravascular Lithotripsy Versus Rotational Atherectomy for Severe Coronary Artery Calcification: A Prospective, Multicenter, Non-inferiority Randomized Controlled Trial
Coronary Artery Calcifications, Intravascular Lithotripsy
Active, not recruitingObservational study
Prognostic Impact of Coronary Microvascular Dysfunction After IVL Versus RA in Patients With Severe Coronary Calcification Undergoing PCI
Coronary Artery Calcification, Intravascular Lithotripsy
Not yet recruitingObservational study
Overviewing Real-World Outcomes to Boost Interventional Management of CAlcified Coronary Lesions: the OROBICA Registry.
Coronary Artery Disease (CAD), Calcific Coronary Arteriosclerosis
Recruiting
Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules (ORBIT-SHOCK).
Coronary Arterial Disease (CAD), Coronary Calcification
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.
Kefei Dou, Doctor principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
Questions about this trial
What is this clinical trial studying?
A study testing intravascular lithotripsy and high-pressure ballon in people with Intravascular Lithotripsy, run by China National Center for Cardiovascular Diseases.
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 8 inclusion and 20 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 29 Jul 2024. 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 Kefei Dou, Doctor (13801032912, drdoukefei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction Rate of Stent Expansion[Effcacy] (time frame: immediately after percutaneous coronary intervention(PCI)). 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 29 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.