Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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.
Eligibility
Primary outcome measure(s)
- Post PCI Stent expansion — At enrollment
Minimal stent area (MSA)/average reference vessel area
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Clermont Ferrand Hospital | Clermont-Ferrand | Auvergne | Recruiting |
| CHU de Clermont-Ferrand | Clermont-Ferrand | France | Not Yet Recruiting |
More University Hospital, Clermont-Ferrand trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07316504 on ClinicalTrials.gov ↗ ← All trials in France