Best way to fix under‑expanded coronary stents in resistant blockages
Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions
This compares intravascular lithotripsy (IVL) with high‑pressure or specialty balloons to see if IVL opens under‑expanded coronary stents better in people with in‑stent restenosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 2 sites (Clermont-Ferrand, Auvergne and 1 other locations) |
| Trial ID | NCT07316504 on ClinicalTrials.gov |
What this trial studies
OSCAR is a randomized, controlled, multicenter trial comparing intravascular lithotripsy (IVL) versus conventional balloon techniques for treatment of stent under‑expansion in patients with in‑stent restenosis. Eligible patients have ≥50% intrastent lumen loss at least 6 months after stent placement with angiographic suspicion of under‑expansion; intracoronary imaging (OCT) is used when feasible to guide treatment. The trial randomizes participants to IVL or standard balloon strategies (including non‑compliant or very‑high‑pressure balloons) and measures angiographic and clinical outcomes including need for repeat revascularization. The goal is to determine whether IVL provides better stent expansion and clinical results than current balloon‑based approaches.
Who should consider this trial
Good fit: Adults with in‑stent restenosis (≥50% diameter loss) occurring ≥6 months after stent implantation with angiographic suspicion of stent under‑expansion, a target vessel 2.5–5.0 mm, TIMI 3 flow, ability to be crossed by an OCT catheter if required, and coverage by French National Health Insurance.
Not a fit: Patients with advanced heart failure (NYHA III–IV), very low LVEF (<20%), severe renal failure (creatinine clearance <30 mL/min), pregnant or breastfeeding women, those unable to comply with follow‑up, or those without evidence of stent under‑expansion are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, IVL could produce better stent expansion and reduce repeat procedures, recurrent angina, and acute coronary events for patients with under‑expanded stents.
How similar studies have performed: Observational series and registry reports have shown IVL to be feasible and safe for under‑expanded, calcified stents, but no prior prospective randomized trials directly comparing IVL with balloon strategies have been completed.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Clermont-Ferrand, Auvergne and 1 other locations
- Clermont Ferrand Hospital — Clermont-Ferrand, Auvergne, France (Recruiting)
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Géraud Souteyrand, MD, PhD — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre, Pharm.D
- Email: promo_interne_drci@chu-clermontferrand.Fr
- Phone: +33473754963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.