Best way to fix under‑expanded coronary stents in resistant blockages

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.