NCT01816854已完成不适用
Endovascular Treatment of Atherosclerotic Lesions in the SFA Using the Sinus-superflex-635 Stent
be Medical1 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2012年10月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Binary restenosis
研究概览
简要总结
In this prospective study, a newly developed self-expanding nitinol stent is evaluated for the treatment of atherosclerotic lesions in the superficial femoral artery and proximal popliteal artery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patient must sign informed consent prior to the index-procedure
- •Patient must be older than 18 years
- •Patient must be compliant with follow-up dates at 1 month and 12 months
- •Patients with intermittent claudication (Rutherford 2-3) and critical limb ischemia (Rutherford 4-5)
- •Target lesion is located in the superficial femoral artery (minimal 1 cm from origin of SFA and minimal 1 cm above the edge of the patella)
- •Reference vessel diameter ≥4.5 and ≤6.5 mm (visual estimate)
- •Patients with a TASC A, B or C lesion
- •Diameter stenosis of target lesion >50% or chronic occlusions
- •Inflow arteries are free of hemodynamically significant obstruction (i.e. ≥50%)
- •The popliteal artery (outflow) is free of hemodynamically significant obstruction (i.e. ≥50%)
- •At least 1 patent below-the-knee vessel (anterior tibial artery, posterior tibial artery or peroneal artery) till the ankle confirmed by baseline angiography
排除标准
- •Patients with Rutherford 1 and 6
- •Patiens with Serum creatinine > 2.0 mg/dL or renal dialysis
- •Patient takes esomeprazole or omeprazole
- •Patient is pregnant
- •Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability
- •Target lesion cannot be crossed with a guidewire
- •Target lesion is located in the popliteal artery
- •Patients with a nickel-titanium allergy
- •Patients with an aneurysm in the superficial femoral artery and popliteal artery
- •Patients with a TASC D lesion
- •Patients with a life expectancy <1 year
- •Patients with scheduled elective non-vascular procedures within 3 months after index-procedure, vascular procedures are allowed within 3 months after index-procedure if it is guaranteed that acetylic salicylic acid and clopidogrel intake is not interrupted
- •Patients with previous bypass surgery in the SFA
- •Patients with intolerance to antithrombotic medication (acetylic salicylic acid, clopidogrel, ticlopidine, glycoprotein IIb/IIIa inhibitors, direct thrombin inhibitors, etc)
- •Patient has not been premedicated with acetylic salicylic acid (at least 80 mg/day) 2 hours before the index-procedure
- •Patient has not been premedicated with clopidogrel (600 mg/day) 2 hours before the index-procedure
结局指标
主要结局
Binary restenosis
时间窗: 12 months
Binary restenosis is defined as a re-obstruction ≥ 50% of the target lesion (peak systolic velocity ratio \> 2.4).
次要结局
- Immediate procedural outcome (procedural, technical and device success)(peri-procedural)
- Distribution of Rutherford stages(12 months)
- Primary sustained clinical improvement(12 months)
- Secondary sustained clinical improvement at 12 months(12 months)
- Mortality(12 months)
- Repeated target lesion revascularization (TLR) rate(12 months)
- Rate of patient clopidogrel resistance(1 month)
- Repeated target extremity revascularization (TER) rate(12 months)
- Amputation rate(12 months)
研究者
研究点 (1)
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