Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions (NCT07316504) | Clinical Trial Compass
RecruitingNot Applicable
Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions
France80 participantsStarted 2025-10-22
Plain-language summary
Percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) accounts for 5-10% of PCI. ISR may be linked to mechanical complications mainly under-expansion (UE), neointimal hyperplasia and/or neoatherosclerosis. International guidelines recommends non-compliant and very-high-pressure balloons, which lead to sub-optimal angiographic and clinical results. Recently, observational studies have suggested the feasibility and safety of intravascular lithotripsy (IVL) in UE treatment. There are no prospective randomised controlled studies comparing intravascular lithotripsy with balloons in ISR with UE.
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 :
* Patient who have undergone coronary angiography with ISR, defined as ≥50% reduction of the diameter of the intrastent lumen occurring ≥ 6 months after stent implantation
* And with a suspicion of stent under-expansion on angiography, possibly assisted by a stent enhancement technique
* The reference diameter of the target vessel must be ≥2.5 mm and ≤5.0 mm.
* Coronary flow must be TIMI 3
* Ability to cross the lesion with the OCT catheter (possibly after predilatation with a balloon up to 2 mm)
* Patient affiliated to the French National Health Insurance
Exclusion criteria :
* Heart failure with NYHA III or IV (or cardiogenic shock)
* LVEF \<20%
* Chronic renal failure with clearance \<30mL/mn according to CKD
* Pregnant or breast-feeding women
* Patient with a condition/comorbidity that could reduce compliance with the protocol, including pre-specified study follow-up
* Patient participating in another ongoing medical study evaluating a pharmacological or biological agent or medical device, unless authorized by the concomitant protocol.
* Patient unable to tolerate double antiaggregation (i.e., aspirin and clopidogrel or prasugrel or ticagrelor) for at least 6 months.
* Possible or defined thrombus (by angiography or endovascular imaging) in the target vessel.
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.