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Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions

NCT07316504 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-01-05

No results posted yet for this 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.

Conditions

  • Coronary Angioplasty
  • Restenosis
  • Lithotripsy
  • Restenosis of Coronary Artery Stent
  • Angioplasty, Transluminal, Percutaneous Coronary
  • Percutaneous Coronary Intervention (PCI)
  • OCT Angiography
  • Optical Coherence Tomography (OCT)
  • Intravascular Lithotripsy; Rotational Atherectomy; OFDI
  • Intravascular Lithotripsy
  • Coronary Artery Disease
  • Coronary Artery Disease (CAD)
  • Coronary Stent Restenosis

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

Sponsors & Collaborators

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Géraud Souteyrand, MD, PhD · CHU de Clermont-Ferrand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-22
Primary Completion
2028-09-30
Completion
2031-09-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07316504 on ClinicalTrials.gov