Lesion; Femoral
Conditions
Keywords
Bypass, Endovascular procedure, Long lesions of the superficial femoral artery
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.
Interventions
PROCEDUREFemoro-popliteal bypass
Under general or local anesthesia: Use of the best vascular substitute (inverted saphenous vein or vascular prosthesis).
PROCEDUREEndovascular procedure
Under general anesthesia, local anesthesia or sedation: Performing a balloon angioplasty completed by preferred stent deployment or drug-coated balloon angioplasty.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency rate at 2 year follow-up. | 2 year | Primary patency is defined by the presence of satisfactory flow in the superior femoral artery or bypass |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency rate at 1 year follow-up. | 1 year | Primary patency is defined by the presence of satisfactory flow in the superior femoral artery or bypass |
| Secondary patency rate at 1 and 2 years follow-up. | 1 and 2 years | Secondary patency is defined as the patency after treatment of a (re)occlusion of the index lesion or bypass. |
| Clinical improvement according to the Rutherford classification (clinical stages of ischemia) at 1, 6, 12 and 24 months | 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. |
| The quality of life measured by the Vascu-Qol 6 to 2 years | 2 years | The quality of life assessment is obtained by filling the Vascu-Qol questionnaire and comparing the score with the preoperative value. |
| The increase in the systolic pressure index at discharge from hospital, then at 1, 6, 12 and 24 months (<0.75,> 0.75) | 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. |
| The treatment burden measured by the Treatment Burden Questionnaire at 6 months | 6 months | The treatment burden is evaluated by comparing the Treatment Burden Questionnaire score at 6 months with the preoperative value. |
| Number of participants with adverse events as assessed by hematoma, redo surgery or vascular infection at 2 years | 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. |
| Improvement of the walking perimeter at 1 and 2 years (<200m,> 200m, unlimited) | 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). |
Countries
France
Contacts
Primary ContactJoseph TOUMA, MD, PhD
Outcome results
None listed