Using angiographic QFR to guide endovascular procedures for leg artery disease
Feasibility Study of an Angiographic Quantitative Flow Ratio-guided Endovascular Procedure in Patients With Lower Limbs Peripheral Arterial Disease.
This study is testing if a special imaging technique can help doctors better plan and improve the success of leg artery treatments for patients with artery disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondation Hôpital Saint-Joseph Academic / other |
| Locations | 1 site (Paris, Île-de-France Region) |
| Trial ID | NCT06516315 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the feasibility of using angiographic Quantitative Flow Ratio (QFR) to predict the success of endovascular revascularization in patients with superficial artery disease. It will involve 35 patients who require endovascular treatment for short stenosis of the superficial femoral artery. Intraoperative angiography will be conducted before the revascularization, and the angiography images will be analyzed post-procedure using Medis QFR®2.2 software. The goal is to improve the assessment of treatment quality and success rates in this patient population.
Who should consider this trial
Good fit: Ideal candidates are French-speaking patients with symptomatic Rutherford stage 2 to 6 lower limb artery disease requiring endovascular revascularization.
Not a fit: Patients with renal failure, those under court protection, or pregnant/breastfeeding individuals may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the accuracy of predicting successful outcomes for patients undergoing endovascular procedures.
How similar studies have performed: While the use of QFR in other vascular contexts has shown promise, this specific application in lower limb artery disease is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with symptomatic Rutherford stage 2 to 6 AOMI with an indication for endovascular revascularization * Patient with a simple lesion (TASC A) and short stenosis of the superficial femoral artery * Patient affiliated to a health insurance system * French-speaking patient * Patient with free, informed and express oral consent Exclusion Criteria: * Renal failure patients with GFR \< 30 ml/min * Patient deprived of liberty * Patients under court protection * Pregnant or breast-feeding patients
Where this trial is running
Paris, Île-de-France Region
- Hôpital Paris Saint-Joseph - 185 Rue Raymond Losserand — Paris, Île-de-France Region, France (Recruiting)
Study contacts
- Principal investigator: Maxime RAUX, Principal investigator — Fondation Hôpital Saint-Joseph
- Study coordinator: Michèle LOHORE
- Email: crc@ghpsj.fr
- Phone: + 331 44127883
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.