NCT05216731招募中不适用
Bypass Versus Endovascular Procedure in Long Lesions of the Superficial Femoral Artery in the Claudicant
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 290
- 试验地点
- 32
- 主要终点
- Primary patency rate at 2 year follow-up.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Primary patency rate at 2 year follow-up.
时间窗: 2 year
Primary patency is defined by the presence of satisfactory flow in the superior femoral artery or bypass
次要结局
- Clinical improvement according to the Rutherford classification (clinical stages of ischemia) at 1, 6, 12 and 24 months(1, 6, 12 and 24 months)
- 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 treatment burden measured by the Treatment Burden Questionnaire at 6 months(6 months)
- Primary patency rate at 1 year follow-up.(1 year)
- Secondary patency rate at 1 and 2 years follow-up.(1 and 2 years)
- Improvement of the walking perimeter at 1 and 2 years (<200m,> 200m, unlimited)(1 and 2 years)
- The quality of life measured by the Vascu-Qol 6 to 2 years(2 years)
- Number of participants with adverse events as assessed by hematoma, redo surgery or vascular infection at 2 years(During 2 years)
研究者
研究点 (32)
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