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Recruiting Not applicable

Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions

NCT07316504 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-10-22
Last updated
2026-01-05

Condition(s) studied

Coronary AngioplastyRestenosisLithotripsyRestenosis of Coronary Artery StentAngioplasty, Transluminal, Percutaneous CoronaryPercutaneous Coronary Intervention (PCI)OCT AngiographyOptical Coherence Tomography (OCT)Intravascular Lithotripsy; Rotational Atherectomy; OFDIIntravascular LithotripsyCoronary Artery DiseaseCoronary Artery Disease (CAD)Coronary Stent Restenosis

Investigational drug(s) / intervention(s)

Intravascular lithotripsyBalloon

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria : * 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 * And with a suspicion of stent under-expansion on angiography, possibly assisted by a stent enhancement technique * The 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 Exclusion criteria : * Heart failure with NYHA III or IV (or cardiogenic shock) * LVEF \<20% * Chronic renal failure with clearance \<30mL/mn according to CKD * Pregnant or breast-feeding women * Patient with a condition/comorbidity that could reduce compliance with the protocol, including pre-specified study follow-up * Patient participating in another ongoing medical study evaluating a pharmacological or biological agent or medical device, unless authorized by the concomitant protocol. * Patient unable to tolerate double antiaggregation (i.e., aspirin and clopidogrel or prasugrel or ticagrelor) for at least 6 months. * Possible or defined thrombus (by angiography or endovascular imaging) in the target vessel.

Primary outcome measure(s)

  • Post PCI Stent expansion — At enrollment
    Minimal stent area (MSA)/average reference vessel area

Trial sites (2)

FacilityCityRegionStatus
Clermont Ferrand Hospital Clermont-Ferrand Auvergne Recruiting
CHU de Clermont-Ferrand Clermont-Ferrand France Not Yet Recruiting
Official registry record

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