Clinical trial NCT05216731: Bypass Versus Endovascular Procedure in Long Lesions of the Superficial Femoral Artery in the Claudicant
Official title: Bypass Versus Endovascular Procedure in Long Lesions of the Superficial Femoral Artery in the Claudicant
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lesion; Femoral
Keywords: Bypass
Endovascular procedure
Long lesions of the superficial femoral artery
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Primary patency rate at 2 year follow-up.
timeFrame: 2 year
Secondary outcomes:
measure: Primary patency rate at 1 year follow-up.
timeFrame: 1 year
measure: Secondary patency rate at 1 and 2 years follow-up.
timeFrame: 1 and 2 years
measure: Clinical improvement according to the Rutherford classification (clinical stages of ischemia) at 1, 6, 12 and 24 months
timeFrame: 1, 6, 12 and 24 months
measure: Improvement of the walking perimeter at 1 and 2 years (<200m,> 200m, unlimited)
timeFrame: 1 and 2 years
measure: The increase in the systolic pressure index at discharge from hospital, then at 1, 6, 12 and 24 months (<0.75,> 0.75)
timeFrame: 1, 6, 12 and 24 months
measure: The quality of life measured by the Vascu-Qol 6 to 2 years
timeFrame: 2 years
measure: The treatment burden measured by the Treatment Burden Questionnaire at 6 months
timeFrame: 6 months
measure: Number of participants with adverse events as assessed by hematoma, redo surgery or vascular infection at 2 years
timeFrame: During 2 years
Other outcomes:
Locations:
city: Créteil
country: France
facility: Assistance Publique Hôpitaux de Paris - CHU Henri Mondor
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Joseph TOUMA, MD, PhD
role: STUDY_DIRECTOR
References: