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RECRUITING
NCT05216731
NA

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

290

Start Date

2025-01-20

Completion Date

2030-05-20

Last Updated

2025-10-03

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Femoro-popliteal bypass

Under general or local anesthesia: Use of the best vascular substitute (inverted saphenous vein or vascular prosthesis).

PROCEDURE

Endovascular procedure

Under general anesthesia, local anesthesia or sedation: Performing a balloon angioplasty completed by preferred stent deployment or drug-coated balloon angioplasty.

Locations (16)

CHU - Hôpitaux de Bordeaux

Bordeaux, France

Hôpital Ambroise Paré, APHP

Boulogne-Billancourt, France

Hôpital de la Cavale Blanche

Brest, France

Centre hospitalier René Dubos

Cergy-Pontoise, France

Hôpital Henri Mondor, APHP

Créteil, France

Hôpital François Mitterrand

Dijon, France

Hôpital Edouard Herriot

Lyon, France

Hôpital de la Timone, APHP

Marseille, France

CHU de Nice

Nice, France

CHU Carémeau

Nîmes, France

Hôpital Européen Georges Pompidou, APHP

Paris, France

Hôpital Bichat - Claude Bernard, APHP

Paris, France

Hôpital La Pitié-Salpêtrière, APHP

Paris, France

CHU de Poitiers

Poitiers, France

CHU de Rangueil

Toulouse, France

Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu

Vandœuvre-lès-Nancy, France