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

Study Overview
=================
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.

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

Conditions
-----------------
Lesion; Femoral

Intervention / Treatment
-----------------
* Procedure: Femoro-popliteal bypass
* Procedure: Endovascular procedure


Participation Criteria
=================
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 LEAD (Lower extremity artery disease) arteritic patient with a lesion of the superficial femoral artery TASC (Trans-Atlantic Inter-Society Consensus) 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) 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 No affiliation to a social security scheme or to another social protection scheme 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: β-HcG (chorionic gonadotropic hormone) positive preoperative laboratory test (results received after obtaining consent, but before randomization)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bypass group<br>Under general anesthesia: Use of the best vascular substitute (inverted saphenous vein or vascular prosthesis). | Procedure: Femoro-popliteal bypass<br>* Under general anesthesia: Use of the best vascular substitute (inverted saphenous vein or vascular prosthesis).<br>|
| Active Comparator: Endovascular procedure group<br>Under local or general anesthesia: Performing a balloon angioplasty completed by preferred stent deployment or drug-coated balloon angioplasty. | Procedure: Endovascular procedure<br>* Preparing the artery with suitable balloon angioplasty followed with stenting (using the preferred material: bare/covered/drug-coated) or drug-coated balloon angioplasty.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bypass, Endovascular procedure, Long lesions of the superficial femoral artery