Bypass Versus Endovascular Procedure in Long Lesions of the Superficial Femoral Artery in the Claudicant

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU - Hôpitaux de Bordeaux
ACTIVE_NOT_RECRUITING
Bordeaux
Hôpital Ambroise Paré, APHP
ACTIVE_NOT_RECRUITING
Boulogne-billancourt
Hôpital de la Cavale Blanche
ACTIVE_NOT_RECRUITING
Brest
Centre hospitalier René Dubos
ACTIVE_NOT_RECRUITING
Cergy-pontoise
Hôpital Henri Mondor, APHP
RECRUITING
Créteil
Hôpital François Mitterrand
RECRUITING
Dijon
Hôpital Edouard Herriot
ACTIVE_NOT_RECRUITING
Lyon
Hôpital de la Timone, APHP
NOT_YET_RECRUITING
Marseille
CHU de Nice
ACTIVE_NOT_RECRUITING
Nice
CHU Carémeau
NOT_YET_RECRUITING
Nîmes
Hôpital Bichat - Claude Bernard, APHP
ACTIVE_NOT_RECRUITING
Paris
Hôpital Européen Georges Pompidou, APHP
ACTIVE_NOT_RECRUITING
Paris
Hôpital La Pitié-Salpêtrière, APHP
NOT_YET_RECRUITING
Paris
CHU de Poitiers
RECRUITING
Poitiers
CHU de Rangueil
ACTIVE_NOT_RECRUITING
Toulouse
Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu
NOT_YET_RECRUITING
Vandœuvre-lès-nancy
Contact Information
Primary
Joseph TOUMA, MD, PhD
joseph.touma@aphp.fr
+ 33 6 30 03 10 93
Time Frame
Start Date: 2025-01-20
Estimated Completion Date: 2030-05-20
Participants
Target number of participants: 290
Treatments
Experimental: Bypass group
Under general or local anesthesia: Use of the best vascular substitute (inverted saphenous vein or vascular prosthesis).
Active_comparator: Endovascular procedure group
Under general anesthesia, local anesthesia or sedation: Performing a balloon angioplasty completed by preferred stent deployment or drug-coated balloon angioplasty.
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov