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Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions
Sponsor: University Hospital, Clermont-Ferrand
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-10-22
Completion Date
2031-09
Last Updated
2026-01-05
Healthy Volunteers
No
Conditions
Interventions
Intravascular lithotripsy
ISR with UE will be treated by intravascular lithotripsy
Balloon
ISR with UE will be treated with non compliant balloons, very high-pressure balloons, cutting balloons
Locations (2)
Clermont Ferrand Hospital
Clermont-Ferrand, Auvergne, France
CHU de Clermont-Ferrand
Clermont-Ferrand, France