Status:
RECRUITING
Bypass Versus Endovascular Procedure in Long Lesions of the Superficial Femoral Artery in the Claudicant
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Lesion; Femoral
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In lower limb peripheral arterial disease, the stage of intermittent claudication has a prevalence of more than 5% over the age of 60, and affects patients who are often still active. Frequent anatomi...
Eligibility Criteria
Inclusion
- Adult patient
- Effective contraception for the duration of research for fertile women of childbearing age
- Unilateral Rutherford 2 or 3 symptomatic Lower Extremity Artery Disease (LEAD) arteritic patient with a lesion of the superficial femoral artery Trans-Atlantic Inter-Society Consensus (TASC) C or D between 15 and 25 cm
- Patient eligible for bypass surgery and endovascular procedure
- No alteration of the upstream flow (iliac flow preserved or restored)
- Patient with at least one patent artery below the knee
- Patient informed and having signed the information and consent form to participate in the study
Exclusion
- Known pregnancy or breastfeeding
- Iliac flow altered upstream
- History of surgery or stent on the affected superficial femoral artery
- Concomitant bacteremia (positive blood cultures in the 7 days preceding the procedure)
- Known intolerance to antiaggregants or heparin
- Contraindication to the endovascular procedure (severe renal failure contraindicating the injection of contrast product despite prior hydration, known severe allergy to iodinated contrast product \[unless the center chooses to use carbon dioxide injection\]) or bypass surgery (cardiovascular, respiratory or other comorbidities, contraindicating general anesthesia, local contraindications for bypass: skin lesion at the operative site)
- No affiliation to a social security regime or to another social protection regime
- Patient deprived of liberty or under legal protection (guardianship, trusteeship)
- Inability, according to the investigator, to understand or refusal to sign the informed consent to participate in the study (non-French speaking patient, cognitive disorders)
- Ongoing participation in another research protocol Participation in non-interventional research is authorized
- Secondary exclusion criterion:
- Negative opinion from the anesthesiologist-resuscitator at the end of the pre-anesthetic consultation
- Positive pregnancy test from the pre-operative laboratory test (result received after obtaining consent, but before the surgical procedure)
Key Trial Info
Start Date :
January 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 20 2030
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT05216731
Start Date
January 20 2025
End Date
May 20 2030
Last Update
October 3 2025
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU - Hôpitaux de Bordeaux
Bordeaux, France, 33 000
2
Hôpital Ambroise Paré, APHP
Boulogne-Billancourt, France, 92 100
3
Hôpital de la Cavale Blanche
Brest, France, 29 200
4
Centre hospitalier René Dubos
Cergy-Pontoise, France, 95 300