Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions

NCT07316504 | Recruiting

• 1 other identifier: RBHP 2025 SOUTEYRAND
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

restenosis; underexpansion; intrastent restenosis; randomized clinical trial; intravascular lithotripsy; baloon PCI; Percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• Post PCI Stent expansion

  Minimal stent area (MSA)/average reference vessel area

  At enrollment

Secondary Outcomes (6)

• Minimal stent area >4.5mm2 or Stent expansion ≥80%

  At enrollment

• Successful lithotripsy catheter delivery

  At enrollment

• Procedural success evaluated by the occurence of the clinical events below

  Day 1 - Day 7

• Peri-procedural complications evaluated by the occurence of the clinical events below

  Day 1- Day 7

• Safety criteria evaluated by the occurence of the clinical events below

  From enrollment to the end of study at Month 36

Study Arms (2)

Intravascular lithotripsy

EXPERIMENTAL

ISR with UE will be treated by intravascular lithotripsy

Procedure: Intravascular lithotripsy

Balloon

ACTIVE COMPARATOR

ISR with UE will be treated with non compliant balloons, very high-pressure balloons, cutting balloons

Procedure: Balloon

Interventions

Intravascular lithotripsy PROCEDURE

ISR with UE will be treated by intravascular lithotripsy

Intravascular lithotripsy

Balloon PROCEDURE

ISR with UE will be treated with non compliant balloons, very high-pressure balloons, cutting balloons

Balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (2)

Clermont Ferrand Hospital

Clermont-Ferrand, Auvergne, 63000, France

RECRUITING

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Géraud Souteyrand, MD, PhD

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre, Pharm.D

CONTACT

+33473754963; promo_interne_drci@chu-clermontferrand.Fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: January 5, 2026
• Study Start: October 22, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2031
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)