Bypass Versus Endovascular Procedure in Long Lesions of the Superficial Femoral Artery in the Claudicant (PELI-CAN)

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.

Study Overview

• Status: Recruiting
• Conditions: Lesion; Femoral
• Intervention / Treatment: Procedure: Femoro-popliteal bypass; Procedure: Endovascular procedure

• Study Type: Interventional
• Enrollment (Estimated): 290
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joseph TOUMA, MD, PhD; Phone Number: + 33 + 33 6 30 03 10 93; Email: joseph.touma@aphp.fr

Study Locations

• France
  • Bordeaux, France, 33 000
    • Active, not recruiting
    • CHU - Hôpitaux de Bordeaux
  • Boulogne-Billancourt, France, 92 100
    • Active, not recruiting
    • Hôpital Ambroise Paré, APHP
  • Brest, France, 29 200
    • Active, not recruiting
    • Hôpital de la Cavale blanche
  • Cergy-Pontoise, France, 95 300
    • Active, not recruiting
    • Centre Hospitalier René Dubos
  • Créteil, France, 94 010
    • Recruiting
    • Hopital Henri MONDOR, APHP
    • Contact: Joseph TOUMA, Pr.; Phone Number: +33 +33 1.49.81.21.60; Email: joseph.touma@aphp.fr
  • Dijon, France, 21 000
    • Recruiting
    • Hôpital François Mitterrand
    • Contact: Eric STEINMETZ, Pr.; Phone Number: +33 03.80.29.33.54; Email: eric.steinmetz@chu-dijon.fr
  • Lyon, France, 69 003
    • Active, not recruiting
    • Hôpital Edouard Herriot
  • Marseille, France, 13 005
    • Not yet recruiting
    • Hôpital de la Timone, APHP
    • Contact: Marine GAUDRY, Dr.; Phone Number: +33 04.91.38.80.92; Email: marine.gaudry@ap-hm.fr
  • Nice, France, 06 001
    • Active, not recruiting
    • CHU de Nice
  • Nîmes, France, 30 029
    • Not yet recruiting
    • CHU Caremeau
    • Contact: Elsa FAURE, Dr.; Phone Number: +33 04.66.68.39.30; Email: elsa.faure@chu-nimes.fr
  • Paris, France, 75 015
    • Active, not recruiting
    • Hôpital Européen Georges Pompidou, APHP
  • Paris, France, 75 018
    • Active, not recruiting
    • Hôpital Bichat - Claude Bernard, APHP
  • Paris, France, 75013
    • Not yet recruiting
    • Hôpital La Pitié-Salpêtrière, APHP
    • Contact: Thibault COUTURE, Dr.; Phone Number: +33 01.42.17.58.08; Email: thibault.couture@aphp.fr
  • Poitiers, France, 86 000
    • Recruiting
    • CHU de Poitiers
    • Contact: Fabrice SCHNEIDER, Pr.; Phone Number: +33 05.49.44.38.46; Email: fabrice.schneider@chu-poitiers.fr
  • Toulouse, France, 31 400
    • Active, not recruiting
    • CHU de Rangueil
  • Vandœuvre-lès-Nancy, France, 54 511
    • Not yet recruiting
    • Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu
    • Contact: Nicla SETTEMBRE, Dr.; Phone Number: +33 03.83.15.43.84; Email: n.settembre@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bypass group; Under general or local anesthesia: Use of the best vascular substitute (inverted saphenous vein or vascular prosthesis).	Procedure: Femoro-popliteal bypass; 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.	Procedure: Endovascular procedure; Under general anesthesia, local anesthesia or sedation: Performing a balloon angioplasty completed by preferred stent deployment or drug-coated balloon angioplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary patency rate at 1 year follow-up.	Primary patency is defined by the presence of satisfactory flow in the superior femoral artery or bypass	1 year
Secondary patency rate at 1 and 2 years follow-up.	Secondary patency is defined as the patency after treatment of a (re)occlusion of the index lesion or bypass.	1 and 2 years
Clinical improvement according to the Rutherford classification (clinical stages of ischemia) at 1, 6, 12 and 24 months	Clinical improvement is considered as an improvement in the Rutherford stage, i.e. a downshift to Rutherford 0 or 1.	1, 6, 12 and 24 months
Improvement of the walking perimeter at 1 and 2 years (<200m,> 200m, unlimited)	Improvement of the walking perimeter is related to Rutherford stage. It is assessed by questioning the patient about the ability to have an unlimited walking distance, or moderately limited (> 200m), or severely limited (<200m).	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)	The increase of the systolic pressure index (SPI) is obtained by comparing all post-operative measures to pre-operative values.	1, 6, 12 and 24 months
The quality of life measured by the Vascu-Qol 6 to 2 years	The quality of life assessment is obtained by filling the Vascu-Qol questionnaire and comparing the score with the preoperative value.	2 years
The treatment burden measured by the Treatment Burden Questionnaire at 6 months	The treatment burden is evaluated by comparing the Treatment Burden Questionnaire score at 6 months with the preoperative value.	6 months
Number of participants with adverse events as assessed by hematoma, redo surgery or vascular infection at 2 years	Tolerance is assessed by looking for the following events during the two postoperative years: hematoma that necessitated hospital stay, vascular infection, or redo surgery because of vascular complication.	During 2 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Joseph TOUMA, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2025
• Primary Completion (Estimated): March 7, 2030
• Study Completion (Estimated): May 20, 2030

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Bypass; Endovascular procedure; Long lesions of the superficial femoral artery
• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Endovascular Procedures
• Other Study ID Numbers: APHP191106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No