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

NCT05216731 | Recruiting

• 1 other identifier: APHP191106
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Lesion; Femoral

Keywords

Bypass; Endovascular procedure; Long lesions of the superficial femoral artery

Outcome Measures

Primary Outcomes (1)

• Primary patency rate at 2 year follow-up.

  Primary patency is defined by the presence of satisfactory flow in the superior femoral artery or bypass

  2 year

Secondary Outcomes (8)

• Primary patency rate at 1 year follow-up.

  1 year

• Secondary patency rate at 1 and 2 years follow-up.

  1 and 2 years

• Clinical improvement according to the Rutherford classification (clinical stages of ischemia) at 1, 6, 12 and 24 months

  1, 6, 12 and 24 months

• Improvement of the walking perimeter at 1 and 2 years (<200m,> 200m, unlimited)

  1 and 2 years

• The increase in the systolic pressure index at discharge from hospital, then at 1, 6, 12 and 24 months (<0.75,> 0.75)

  1, 6, 12 and 24 months

Study Arms (2)

Bypass group

EXPERIMENTAL

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

Procedure: Femoro-popliteal bypass

Endovascular procedure group

ACTIVE COMPARATOR

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

Procedure: Endovascular procedure

Interventions

Femoro-popliteal bypass PROCEDURE

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

Bypass group

Endovascular procedure PROCEDURE

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

Endovascular procedure group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (16)

CHU - Hôpitaux de Bordeaux

Bordeaux, 33 000, France

ACTIVE NOT RECRUITING

Hôpital Ambroise Paré, APHP

Boulogne-Billancourt, 92 100, France

ACTIVE NOT RECRUITING

Hôpital de la Cavale Blanche

Brest, 29 200, France

ACTIVE NOT RECRUITING

Centre hospitalier René Dubos

Cergy-Pontoise, 95 300, France

ACTIVE NOT RECRUITING

Hôpital Henri Mondor, APHP

Créteil, 94 010, France

RECRUITING

Hôpital François Mitterrand

Dijon, 21 000, France

RECRUITING

Hôpital Edouard Herriot

Lyon, 69 003, France

ACTIVE NOT RECRUITING

Hôpital de la Timone, APHP

Marseille, 13 005, France

NOT YET RECRUITING

CHU de Nice

Nice, 06 001, France

ACTIVE NOT RECRUITING

CHU Carémeau

Nîmes, 30 029, France

NOT YET RECRUITING

Hôpital Européen Georges Pompidou, APHP

Paris, 75 015, France

ACTIVE NOT RECRUITING

Hôpital Bichat - Claude Bernard, APHP

Paris, 75 018, France

ACTIVE NOT RECRUITING

Hôpital La Pitié-Salpêtrière, APHP

Paris, 75013, France

NOT YET RECRUITING

CHU de Poitiers

Poitiers, 86 000, France

RECRUITING

CHU de Rangueil

Toulouse, 31 400, France

ACTIVE NOT RECRUITING

Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu

Vandœuvre-lès-Nancy, 54 511, France

NOT YET RECRUITING

MeSH Terms

Interventions

Endovascular Procedures

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Joseph TOUMA, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Joseph TOUMA, MD, PhD

CONTACT

+ 33 6 30 03 10 93; joseph.touma@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: January 31, 2022
• Study Start: January 20, 2025
• Primary Completion (Estimated): March 7, 2030
• Study Completion (Estimated): May 20, 2030
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

FR (16)