Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents - Siberia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Changes in chronic lower limb ischemia at 12 months follow-up
研究概览
简要总结
Endovascular treatment with stenting is currently used in the treatment of femoro-popliteal lesions. This technique tends to extend to lesions for which the gold standard remains until now the open surgery treatment (lesions TASC C and D).
The primary objective of the study was to evaluate the clinical efficacy at 12 months of the SuperA stent (Abbott) in the treatment of long de novo atherosclerotic lesions TASC C and D in patients with symptomatic peripheral arterial disease. The secondary objectives are to evaluate the clinical effectiveness of the SuperA stent at 24 months, according to clinical, morphological and haemodynamic criterias, the possible influence of calcifications and the quality of life of patients
详细描述
Patient will be recruiting during 1 year. Patient will be followed in the study during 2 years. Pre-operative exams are collected. Patients are asked to give their oral authorization to participate in the study by their surgeon.
Patient can be included up to the next day of the intervention.
Endovascular treatment of femoropopliteal lesion with SuperA stents :
Intervention will be achieved in operative room, under local anesthesia and sedation or general anesthesia. An angio-CT or an arteriography is necessary to attest the presence for TASC C or D lesion involving the superficial femoral and/or popliteal arteries.
The long femoropopliteal lesion must be pre-dilated during 3 minutes with a balloon of 1mm diameter more than the stent to be implanted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic PAD, Rutherford 2 to 6
- •Atherosclerotic femoropopliteal lesion TASC C or D (on CT scan or arteriography)
- •De novo femoropopliteal lesion
- •Patient informed of the study and oral authorization collected
排除标准
- •Under-age patient
- •Patient of age, but under legal guardianship or care
- •Potentially pregnant women
- •Patients do not understand the French language
- •Asymptomatic lesion
- •Acute ischemia or acute thrombosis
- •Lesion already treated
- •No-atherosclerotic disease
- •hemostasis disorder
- •severe comorbidity with life expectancy less than 2 years
- •contraindication of antiplatelet (dual antiplatelet therapy required during at least 2 month post-intervention)
- •patient participating in a clinical trial likely to interfer
- •Comorbidity or other, according investigator, that may interfere with the conduct of the study
- •lesion near to an aneurysm
- •Patient follow-up impossible
- •Patient refuse to participate
结局指标
主要结局
Changes in chronic lower limb ischemia at 12 months follow-up
时间窗: 12 months
Number of cases of improvement of at least 1 category of Rutherford classification for claudicants. Healing of a trophic disorder and disappearance of resting pain for patient with critical ischemia
次要结局
- Major adverse limb events(24 months)
- Limb salvage rate(24 months)
- Changes in ankle-brachial index(24 months)
- Major adverse cardiovascular events(24 months)
- Primary patency(24 months)
- Secondary patency(24 months)
- Thrombosis rate(24 months)
- Changes in chronic lower limb ischemia at 24 months follow-up(24 months)
- Changes in the patients quality of life(1, 12, 24 months)
- Restenosis rate(24 months)