NCT07316504

Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In-stent restenosis (ISR) angioplasties account for between 5 and 10% of Percutaneous coronary intervention (PCI). Several mechanisms are causing RIS, including neointimal hyperplasia, neoatherosclerosis, and/or mechanical complications, mainly stent under-expansion. In addition, the calcified lesions associated with stent under-expansion are under-diagnosed in angiography as shown by intra-coronary imaging studies. The stent under-expansion is defined as a ratio between the minimum intrastent surface area and the average vessel lumen of \<80%. Currently, the management of these lesions is not codified and consists empirically of the use of non-compliant balloons, cutting balloons, and/or very high-pressure balloons. These treatments result in suboptimal angiographic results, with clinical consequences in terms of revascularization recurrence (angina, unstable angina, and in 25% of cases, acute coronary syndrome). A growing interest in intravascular lithotripsy (IVL) use to treat these calcified lesions with stent underexpansion appears as an appealing option for a safe procedure but without robust data on efficacy. Furthermore, guidelines published in 2020 by the expert consensus of the EAPCI (European Association of Percutaneous Coronary Interventions) classified IVL among the therapeutic strategy indicated in stent under-expansion with calcified lesions. The OSCAR study is a randomized, controlled, multicenter trial investigating the use of IVL compared to other standard strategies in the treatment of in-stent restenosis with under-expansion.

Conditions

• Coronary Angioplasty
• Restenosis
• Lithotripsy
• Restenosis of Coronary Artery Stent
• Angioplasty, Transluminal, Percutaneous Coronary
• Percutaneous Coronary Intervention (PCI)
• OCT Angiography
• Optical Coherence Tomography (OCT)
• Intravascular Lithotripsy; Rotational Atherectomy; OFDI
• Intravascular Lithotripsy
• Coronary Artery Disease
• Coronary Artery Disease (CAD)
• Coronary Stent Restenosis

Interventions

Type	Name	Description
PROCEDURE	Intravascular lithotripsy	ISR with UE will be treated by intravascular lithotripsy
PROCEDURE	Balloon	ISR with UE will be treated with non compliant balloons, very high-pressure balloons, cutting balloons

Timeline

• Start date: 2025-10-22
• Primary completion: 2028-09-01
• Completion: 2031-09-01
• First posted: 2026-01-05
• Last updated: 2026-01-05

Locations

2 sites across 1 country: France