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RECRUITING
NCT07316504
NA

Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions

Sponsor: University Hospital, Clermont-Ferrand

View on ClinicalTrials.gov

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

Interventions

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

Locations (2)

Clermont Ferrand Hospital

Clermont-Ferrand, Auvergne, France

CHU de Clermont-Ferrand

Clermont-Ferrand, France