Informations générales (source: ClinicalTrials.gov)
Bypass Versus Endovascular Procedure in Long Lesions of the Superficial Femoral Artery in the Claudicant
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
janvier 2025
mai 2030
02 novembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | TOUMA Joseph | 27/12/2025 07:29:55 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 27/12/2025 07:29:56 | Contacter | |||
| AP-HP - Hôpital Ambroise Paré | |||||
| AP-HP - Hôpital Bichat | |||||
| AP-HP - Hôpital Europeen Georges Pompidou | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| IFSI-IFAS DU CH BICHAT-CLAUDE BERNARD | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Carémeau - 30 029 - Nîmes 2990363 - France | Elsa FAURE, Dr. | Contact (sur clinicalTrials) | |||
| CHU de Poitiers - 86 000 - Poitiers 2986495 - France | Fabrice SCHNEIDER, Pr. | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU - Hôpitaux de Bordeaux - 33 000 - Bordeaux 3031582 - France | Contact (sur clinicalTrials) | ||||
| CHU de Nice - 06 001 - Nice 2990440 - France | Contact (sur clinicalTrials) | ||||
| Hôpital Ambroise Paré, APHP - 92 100 - Boulogne-Billancourt 3031137 - France | Contact (sur clinicalTrials) | ||||
| Hôpital de la Timone, APHP - 13 005 - Marseille 2995469 - France | Marine GAUDRY, Dr. | Contact (sur clinicalTrials) | |||
| Hôpital Edouard Herriot - 69 003 - Lyon 2996944 - France | Contact (sur clinicalTrials) | ||||
| Hôpital François Mitterrand - 21 000 - Dijon 3021372 - France | Eric STEINMETZ, Pr. | Contact (sur clinicalTrials) | |||
| Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu - 54 511 - Vandœuvre-lès-Nancy 2970797 - France | Nicla SETTEMBRE, Dr. | Contact (sur clinicalTrials) | |||
Critères
Tous
- 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 Criteria:
- 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)