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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
290
Under general or local anesthesia: Use of the best vascular substitute (inverted saphenous vein or vascular prosthesis).
Under general anesthesia, local anesthesia or sedation: Performing a balloon angioplasty completed by preferred stent deployment or drug-coated balloon angioplasty.
CHU - Hôpitaux de Bordeaux
Bordeaux, France
ACTIVE_NOT_RECRUITINGHôpital Ambroise Paré, APHP
Boulogne-Billancourt, France
ACTIVE_NOT_RECRUITINGHôpital de la Cavale Blanche
Brest, France
ACTIVE_NOT_RECRUITINGCentre hospitalier René Dubos
Cergy-Pontoise, France
ACTIVE_NOT_RECRUITINGHôpital Henri Mondor, APHP
Créteil, France
RECRUITINGHôpital François Mitterrand
Dijon, France
RECRUITINGHôpital Edouard Herriot
Lyon, France
ACTIVE_NOT_RECRUITINGHôpital de la Timone, APHP
Marseille, France
NOT_YET_RECRUITINGCHU de Nice
Nice, France
ACTIVE_NOT_RECRUITINGCHU Carémeau
Nîmes, France
NOT_YET_RECRUITING...and 6 more locations
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
Time frame: 2 year
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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During 2 years
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