Actively Recruiting
Optimal Strategy to Correct Stent Underexpansion in Resistant Lesions using Intravascular Lithotripsy versus Balloon Treatments
Led by University Hospital, Clermont-Ferrand · Updated on 2026-01-05
80
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the best way to treat in-stent restenosis (ISR) caused by stent under-expansion (UE), which occurs in 5-10% of patients undergoing percutaneous coronary intervention (PCI). ISR can result from mechanical issues like under-expansion, neointimal hyperplasia, or neoatherosclerosis. Current guidelines recommend using non-compliant and very-high-pressure balloons, but these often lead to less than ideal results. This trial compares intravascular lithotripsy (IVL) with balloon treatments in patients with ISR and UE to evaluate which approach is more effective and safe. The study randomly assigns patients to one of two treatments: one group receives IVL to treat ISR with UE, while the other group is treated with non-compliant balloons, very high-pressure balloons, or cutting balloons. IVL is a newer method suggested to safely address calcified lesions causing stent under-expansion, while balloon treatments are standard but may be less effective. The trial will carefully monitor the treatment delivery and success during the procedure and follow patients for up to 36 months. Participants will undergo coronary angiography and optical coherence tomography (OCT) imaging to assess stent expansion and lesion characteristics. Researchers will measure the stent expansion immediately after PCI and track clinical events such as procedural success, complications, and safety outcomes during the first week and throughout the 36-month follow-up. The study includes detailed evaluations of minimal stent area, success of device delivery, and any adverse events to understand the long-term effectiveness and safety of the treatments.
CONDITIONS
Brief Title
Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has undergone coronary angiography with in-stent restenosis showing at least 50% narrowing occurring 6 months or more after stent implantation
- Suspicion of stent under-expansion on angiography, possibly with stent enhancement technique
- Reference diameter of target vessel between 2.5 mm and 5.0 mm
- Coronary flow must be TIMI grade 3
- Ability to cross the lesion with an OCT catheter, possibly after predilatation with a balloon up to 2 mm
- Patient is affiliated with the French National Health Insurance
You will not qualify if you...
- Heart failure classified as NYHA III or IV, or cardiogenic shock
- Left ventricular ejection fraction less than 20%
- Chronic renal failure with clearance below 30 mL/min according to CKD
- Pregnant or breastfeeding women
- Any condition or comorbidity that could reduce compliance with the study protocol or follow-up
- Participation in another ongoing medical study involving pharmacological, biological agents, or medical devices unless authorized
- Inability to tolerate double antiaggregation therapy (aspirin plus clopidogrel, prasugrel, or ticagrelor) for at least 6 months
- Presence of possible or defined thrombus in the target vessel by imaging or angiography
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 1 to Day 7
Participants receive treatment for in-stent restenosis with stent under-expansion using either intravascular lithotripsy or balloon techniques.
1 treatment visit and daily visits for up to 7 days
Duration - Up to 36 months
Participants are monitored for safety and effectiveness of the treatment up to 36 months after enrollment.
Regular follow-up visits over 36 months
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
Research Team
L
Lise Laclautre, Pharm.D
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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