NCT07316504 Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions
| NCT ID | NCT07316504 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Clermont-Ferrand |
| Condition | Coronary Angioplasty |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-10-22 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-10-22 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Géraud Souteyrand, MD, PhD
PRINCIPAL INVESTIGATOR
University Hospital, Clermont-Ferrand
Frequently Asked Questions
Who can join the NCT07316504 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Angioplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07316504 currently recruiting?
Yes, NCT07316504 is actively recruiting participants. Contact the research team at promo_interne_drci@chu-clermontferrand.Fr for enrollment information.
Where is the NCT07316504 trial being conducted?
This trial is being conducted at Clermont-Ferrand, France, Clermont-Ferrand, France.
Who is sponsoring the NCT07316504 clinical trial?
NCT07316504 is sponsored by University Hospital, Clermont-Ferrand. The principal investigator is Géraud Souteyrand, MD, PhD at University Hospital, Clermont-Ferrand. The trial plans to enroll 80 participants.