Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions

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.

NCT Number	NCT07316504
Lead Sponsor	University Hospital, Clermont-Ferrand
Conditions	Coronary Angioplasty, Restenosis, Lithotripsy, Restenosis of Coronary Artery Stent, Angioplasty, Transluminal, Percutaneous Coronary, Percutaneous Coronary Intervention (PCI), OCT Angiography, Optical Coherence Tomography (OCT) +5 more
Enrollment	80 participants
Start Date	2025-10-22
Primary Completion	2028-09 (estimated)
Study Completion	2031-09 (estimated)
Updated on ClinicalTrials.gov	2026-01-05