Actively Recruiting
Bypass Versus Endovascular Procedure in Long Lesions of the Superficial Femoral Artery in the Claudicant
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-10-03
290
Participants Needed
16
Research Sites
278 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 anatomical lesions are strictures / occlusions of the superficial femoral artery. There is a current low level of evidence for the treatment modalities of long lesions (15-25 cm) of the superficial femoral artery and in particular no clinical trial comparing the femoro-popliteal bypass to the endovascular procedure whose patency in retrospective series. appears lower than that of surgery but nevertheless appears in the European recommendations for first-line treatment, with the absence of a dedicated trial being highlighted.
CONDITIONS
Official Title
Bypass Versus Endovascular Procedure in Long Lesions of the Superficial Femoral Artery in the Claudicant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient
- Effective contraception for fertile women of childbearing age during the study
- Unilateral Rutherford 2 or 3 symptomatic Lower Extremity Artery Disease with a 15 to 25 cm lesion in the superficial femoral artery classified as TASC C or D
- Eligible for both bypass surgery and endovascular procedure
- No alteration in upstream iliac blood flow (preserved or restored)
- At least one patent artery below the knee
- Informed and signed consent to participate in the study
You will not qualify if you...
- Known pregnancy or breastfeeding
- Altered iliac blood flow upstream
- Previous surgery or stent on the affected superficial femoral artery
- Bacteremia with positive blood cultures within 7 days before procedure
- Known intolerance to antiaggregants or heparin
- Contraindications to endovascular procedure (e.g., severe renal failure or allergy to contrast) or to bypass surgery (e.g., severe comorbidities, skin lesions at surgery site)
- No social security or social protection affiliation
- Under legal protection or deprived of liberty
- Unable or unwilling to understand or sign informed consent (e.g., non-French speaking, cognitive disorders)
- Participation in another interventional research protocol
- Negative opinion from anesthesiologist after pre-anesthetic consultation
- Positive pregnancy test before surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
CHU - Hôpitaux de Bordeaux
Bordeaux, France, 33 000
Active, Not Recruiting
2
Hôpital Ambroise Paré, APHP
Boulogne-Billancourt, France, 92 100
Active, Not Recruiting
3
Hôpital de la Cavale Blanche
Brest, France, 29 200
Active, Not Recruiting
4
Centre hospitalier René Dubos
Cergy-Pontoise, France, 95 300
Active, Not Recruiting
5
Hôpital Henri Mondor, APHP
Créteil, France, 94 010
Actively Recruiting
6
Hôpital François Mitterrand
Dijon, France, 21 000
Actively Recruiting
7
Hôpital Edouard Herriot
Lyon, France, 69 003
Active, Not Recruiting
8
Hôpital de la Timone, APHP
Marseille, France, 13 005
Not Yet Recruiting
9
CHU de Nice
Nice, France, 06 001
Active, Not Recruiting
10
CHU Carémeau
Nîmes, France, 30 029
Not Yet Recruiting
11
Hôpital Européen Georges Pompidou, APHP
Paris, France, 75 015
Active, Not Recruiting
12
Hôpital Bichat - Claude Bernard, APHP
Paris, France, 75 018
Active, Not Recruiting
13
Hôpital La Pitié-Salpêtrière, APHP
Paris, France, 75013
Not Yet Recruiting
14
CHU de Poitiers
Poitiers, France, 86 000
Actively Recruiting
15
CHU de Rangueil
Toulouse, France, 31 400
Active, Not Recruiting
16
Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu
Vandœuvre-lès-Nancy, France, 54 511
Not Yet Recruiting
Research Team
J
Joseph TOUMA, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here