NCT07316504Recruiting
Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions
Source: ClinicalTrials.gov · Last updated 5 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 5 Sept 2025
- Start date
- 22 Oct 2025
- Primary completion date
- Sept 2028
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Diseases
- Coronary artery disease
- NCT number
- NCT07316504
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 22 Oct 2025 to the primary completion date, Sept 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient participating in another ongoing medical study evaluating a pharmacological or biological agent or medical device, unless authorized by the concomitant protocol.
Other illness
- Heart failure with NYHA III or IV (or cardiogenic shock)
- Patient with a condition/comorbidity that could reduce compliance with the protocol, including pre-specified study follow-up
Lab values
- LVEF \<20%
- Chronic renal failure with clearance \<30mL/mn according to CKD
Other
- Pregnant or breast-feeding women
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Not yet recruiting |
| Clermont-Ferrand Hospital Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.