Femoro-popliteal bypass
ProcedureUnder general or local anesthesia: Use of the best vascular substitute (inverted saphenous vein or vascular prosthesis).
Recruiting
NCT Number: NCT05216731
Bypass Versus Endovascular Procedure in Long Lesions of the Superficial Femoral Artery in the Claudicant
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
CHU - Hôpitaux de Bordeaux, Bordeaux, France
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Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
endovascular procedure
ProcedureUnder general anesthesia, local anesthesia or sedation: Performing a balloon angioplasty completed by preferred stent deployment or drug-coated balloon angioplasty.
Primary outcomes
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Primary patency rate at 2 year follow-up.
Time frame: 2 year
Primary patency is defined by the presence of satisfactory flow in the superior femoral artery or bypass
Secondary outcomes
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Primary patency rate at 1 year follow-up.
Time frame: 1 year
Primary patency is defined by the presence of satisfactory flow in the superior femoral artery or bypass
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Secondary patency rate at 1 and 2 years follow-up.
Time frame: 1 and 2 years
Secondary patency is defined as the patency after treatment of a (re)occlusion of the index lesion or bypass.
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Clinical improvement according to the Rutherford classification (clinical stages of ischemia) at 1, 6, 12 and 24 months
Time frame: 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.
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Improvement of the walking perimeter at 1 and 2 years (<200m,> 200m, unlimited)
Time frame: 1 and 2 years
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).
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The increase in the systolic pressure index at discharge from hospital, then at 1, 6, 12 and 24 months (<0.75,> 0.75)
Time frame: 1, 6, 12 and 24 months
The increase of the systolic pressure index (SPI) is obtained by comparing all post-operative measures to pre-operative values.
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The quality of life measured by the Vascu-Qol 6 to 2 years
Time frame: 2 years
The quality of life assessment is obtained by filling the Vascu-Qol questionnaire and comparing the score with the preoperative value.
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The treatment burden measured by the Treatment Burden Questionnaire at 6 months
Time frame: 6 months
The treatment burden is evaluated by comparing the Treatment Burden Questionnaire score at 6 months with the preoperative value.
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Number of participants with adverse events as assessed by hematoma, redo surgery or vascular infection at 2 years
Time frame: During 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Other
Registry information
Acronym: PELI-CAN
Important dates
- Study start
- 2025
- Primary completion
- 2030
- Study completion
- 2030
- First posted
- Jan 31, 2022
- Registry last updated
- Oct 3, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.