Pilot Study to Investigate Safety, Effectiveness and Feasibility of LimFlow Stent Graft System for Creating an AV Fistula for the Treatment of Critical Limb Ischemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 13
- 主要终点
- Amputation-free Survival
研究概览
简要总结
This pilot study will investigate the safety, effectiveness and feasibility of the LimFlow Stent Graft System for creating an AV fistula in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive approach for the treatment of Critical Limb Ischemia (CLI) in subjects ineligible for conventional endovascular or surgical limb salvage procedures.
详细描述
The PROMISE I Trial was a prospective, multi-center, single-arm, investigational feasibility study assessing the LimFlow System for the treatment of chronic- limb-threatening ischemia by creating an arterio-venous fistula in the below-the-knee vasculature. The study was run under an investigational device exemption (IDE G160156, NCT03124875).
Thirty-two subjects were enrolled under protocol revisions A, B, C, and D at seven sites in the United States between 5-July-2017 and 8-April-2019.
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
- 21 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of critical limb ischemia with hemodynamic evidence of severely diminished arterial inflow of the index limb and Rutherford Classification 5 r 6
- •Reviewed and approved for eligibility by the Investigator and the Independent Safety Committee (ISC)
排除标准
- •Concomitant hepatic or renal insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder
- •Severe heart failure, recent MI or stroke
- •Significant peripheral edema or infection that may preclude insertion of a prosthesis or significantly impair wound healing
- •Known allergies or contraindications to anti platelet therapy or device materials
- •Immunodeficiency disorder or immunosuppressant therapy
- •Life expectancy < 12 months
结局指标
主要结局
Amputation-free Survival
时间窗: 30 days post-procedure
Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality
次要结局
- Amputation-free Survival(6 months post-procedure)
- Secondary Patency(6 months post-procedure)
- Technical Success(Post-procedure, immediately)
- Procedural Success(30 days post-procedure)
- Primary Patency(6 months post-procedure)
- Limb Salvage(12 months post-procedure)
- Wound Healing(12 months post-procedure)
- Deterioration in Renal Function(6 months post-procedure)