ClinicAL outComes of IntraVascular Lithotripsy Combined With Conventional Lesion Preparation in P… (NCT07340294) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
ClinicAL outComes of IntraVascular Lithotripsy Combined With Conventional Lesion Preparation in Patients With Moderate to Severe Coronary Artery Calcification
China1,096 participantsStarted 2025-10-24
Plain-language summary
The goal of this clinical trial is to investigate whether the clinical outcomes of combined application of intravascular lithotripsy (IVL) following routine preconditioning are superior to those of routine preconditioning alone in patients with moderate-to-severe coronary artery calcification (CAC). Its core research questions are as follows:
A. To evaluate whether routine or combined application of shockwave intravascular lithotripsy can effectively reduce the target vessel failure rate in moderate-to-severe coronary artery calcification lesions.
B. To evaluate the long-term prognosis of patients with coronary artery calcification.
The researchers will compare the experimental group (routine preconditioning plus IVL) and the control group (routine preconditioning alone) to determine whether the combined use of intravascular lithotripsy following routine preconditioning can improve patient prognosis.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients ≥ 18 years old
* Acute or chronic coronary syndrome requiring PCI
* De novo coronary lesions (excluding bypass grafts and prior stented lesions) with a target vessel reference diameter of ≥ 2.5 mm and ≤ 4.0 mm
* Moderate to severe calcification, meeting one of the following criteria: • Intravascular imaging criteria: IVUS calcium score ≥ 2 points (IVUS scoring standards: a. Calcification \> 270 degrees and length \> 5 mm; b. Circumferential calcification (360 degrees); c. Calcific nodules; d. Vessel diameter \< 3.5 mm) OCT calcium score ≥ 3 points (OCT scoring standards: a. Calcification ≤ 180 degrees: 0 points; \> 180 degrees: 2 points; b. Thickness ≤ 0.5 mm: 0 points; \> 0.5 mm: 1 point; c. Length ≤ 5 mm: 0 points; \> 5 mm: 1 point) • Contrast-based classification criteria apply when intravascular imaging devices cannot pass: Coronary angiography shows clear high-density calcific shadows visible during cardiac pulsation, or clear high-density calcific shadows visible both during and without cardiac pulsation, with the length of calcific shadows on both sides of the target lesion \> 5 mm.
* Willing and able to provide written informed consent
Exclusion Criteria:
* Patients under 18 years of age
* Patients unable to provide informed consent
* Pregnant or lactating female patients (pregnancy test must be performed within 7 days before surgery for women of childbearing age)
* Thrombus detected by angiography or intravascular imaging
* Patients …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
target vessel failure rate
Timeframe: 1month; 12 months; 24 months
Trial details
NCT IDNCT07340294
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University