Informations générales (source: ClinicalTrials.gov)

NCT05216731 En recrutement IDF
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)
août 2024
janvier 2030
03 octobre 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.
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Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
HOPITAL NOVO TOUMA Joseph En recrutement IDF 25/10/2025 09:41:53  Contacter
AP-HP Assistance publique - Hôpitaux de Paris En recrutement IDF 25/10/2025 09:41:54  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

Critères

Tous
Inclusion Criteria:

- 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


- 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)