A Prospective Randomized, Parallel-group, Multicentre, Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Difference in primary patency rate (proportion of patients classed as treatment succsess)
研究概览
简要总结
The purpose of this study (superiority trial) is to compare the Supera® Peripheral Stent System with a standard nitinol self-expanding stent for treatment of femoro-popliteal arterial occlusive disease.
Hypothesis:
The Supera® stent is superior to a standard nitinol self-expanding stent, for treatment of femoro-popliteal artery disease in terms of (1) primary patency rate and (2) need for revascularization up to 24 months after stent insertion.
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
- None
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
- •Patients with femoro-popliteal artery disease, who will require a stent femoro-popliteal following failed percutaneous transluminal angioplasty (PTA)
- •Target Lesion length <200mm
- •Planned follow-up available for at least 24 months
- •Written informed consent to participate in the study and agreement to comply with the study protocol must be obtained from the patient prior to initiation of any study-mandated procedure and randomization
排除标准
- •Life expectancy <24 months
- •Patients who cannot receive dual antiplatelet therapy (aspirin 100mg and clopidogrel 75mg) or anticoagulation therapy
- •Patients with known allergies to: nitinol (nickel titanium); or contrast agent, that cannot be medically managed
- •Participation in another study with investigational drug/device within the 30 days preceding and during the present study
- •Previous enrolment into the current study
- •Prior stenting at the location of intended stenting
- •Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system
- •Enrolment of study investigator, his/her family members, employees and other dependent persons
- •If female and of childbearing potential: known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
研究组 & 干预措施
EverFlex™ Self-Expanding Peripheral Stent System
Femoro-popliteal arterial stenting with EverFlex™ Self-Expanding Peripheral Stent System with Entrust™ Delivery System or as Protégé™ EverFlex™
干预措施: EverFlex™ Self-Expanding Peripheral Stent System (Device)
Supera® Peripheral Stent System
Femoro-popliteal arterial stenting with Supera® Peripheral Stent System as CE-marked by the manufacturer Abbott
干预措施: Supera® Peripheral Stent System (Device)
结局指标
主要结局
Difference in primary patency rate (proportion of patients classed as treatment succsess)
时间窗: 24 months
Peak systolic velocity ratio assessed with Duplex ultrasound (Treatment success is defined as Peak Systolic Velocity (PSV) ratio \< 2.5 at the stented target lesion measured by Duplex ultrasound (DUS) indicating freedom from \>50% restenosis with no clinically driven re-intervention within the stented segment.)
次要结局
- Difference in primary patency rate(1 month, 6 months, 12 months)
- Difference in target lesion/vessel revascularization(24 months)
- Difference in amputation(24 months)
- Difference in time to restenosis (and time to target lesion revascularization due to restenosis)(24 months)
- Difference in Fontaine classification(1 month, 6 months, 12 months, 24 months)
- Difference in Anklre Brachial Index(1 month, 6 months, 12 months, 24 months)