Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07316504

Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions

Led by University Hospital, Clermont-Ferrand · Updated on 2026-01-05

80

Participants Needed

2

Research Sites

305 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient who have undergone coronary angiography with ISR, defined as 50% reduction of the diameter of the intrastent lumen occurring  6 months after stent implantation
  • Suspicion of stent under-expansion on angiography, possibly assisted by a stent enhancement technique
  • Reference diameter of the target vessel must be 2.5 mm and 5.0 mm
  • Coronary flow must be TIMI 3
  • Ability to cross the lesion with the OCT catheter (possibly after predilatation with a balloon up to 2 mm)
  • Patient affiliated to the French National Health Insurance
Not Eligible

You will not qualify if you...

  • Heart failure with NYHA III or IV (or cardiogenic shock)
  • Left ventricular ejection fraction (LVEF) 20%
  • Chronic renal failure with clearance 30mL/mn according to CKD
  • Pregnant or breast-feeding women
  • Condition or comorbidity that could reduce compliance with the protocol or follow-up
  • Participation in another medical study evaluating a drug or device unless authorized
  • Unable to tolerate double antiaggregation (aspirin and clopidogrel, prasugrel, or ticagrelor) for at least 6 months
  • Possible or defined thrombus in the target vessel by angiography or endovascular imaging

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Clermont Ferrand Hospital

Clermont-Ferrand, Auvergne, France, 63000

Actively Recruiting

2

CHU de Clermont-Ferrand

Clermont-Ferrand, France, 63000

Not Yet Recruiting

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Research Team

L

Lise Laclautre, Pharm.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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