NCT04003480暂停不适用
Prospective, Multicenter Study Evaluating the Performance and Safety of FRAME, External Support for Lower Limb Autologous Grafts.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Primary patency
研究概览
简要总结
30 patients will be enrolled in a prospective, multi-center, one-arm study, enrolling patients with claudication and chronic limb ischemia scheduled for lower limb venous bypass grafting on clinical grounds with single segment autologous saphenous vein.
Subjects will be followed for 5 years, with follow up visits at 1, 3, 6, 12 months, 2, 3, 4, 5, years post operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Patient scheduled for infrainguinal peripheral artery bypass surgery with single segment autogenous saphenous vein.
- •Rutherford classification 3-6
- •Adequate revascularization target defined as an infrainguinal arterial segment distal to the area of stenosis/occlusion which can support a distal anastomosis of a surgical bypass.
- •Patient is able and willing to give their informed written consent.
- •Patient is able and willing to comply with study follow up requirements.
- •Patient is ≥ 18 years of age
排除标准
- •Patients indicated for endovascular treatment
- •Prior surgical bypass procedure in ipsilateral lower limb.
- •Active ulcer/infection/gangrene at the intended distal anastomosis site.
- •Severe vein varicosity
- •Saphenous vein with external pressurized diameter of less than 3.5 mm or more than 8 mm.
- •Spliced vein technique
- •In-situ vein technique
- •Pedal/plantar distal anastomosis
- •Planned above ankle amputation on ipsilateral limb within 4 weeks of index procedure.
- •Patients with history of hypercoagulable conditions.
- •Patients with significant stenoses distal to the planned anastomotic site and any other known conditions that could adversely affect graft patency.
- •Concomitant life-threatening disease likely to limit life expectancy to less than 2 years.
- •Contraindication to recommended study medications
- •Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
研究组 & 干预措施
FRAME
Experimental
Vein graft to be treated with FRAME
干预措施: FRAME (Device)
结局指标
主要结局
Primary patency
时间窗: 12 months
Freedom of vein graft from occlusion and clinically driven target lesion revascularization as measured by Doppler Ultrasound
次要结局
未报告次要终点
研究者
研究点 (3)
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