NCT05313165招募中不适用
Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia: The PROMISE III Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 42
- 主要终点
- Amputation Free Survival
研究概览
简要总结
A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.
详细描述
The objective of this study is to provide additional information on the LimFlow System for creating an AV connection in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive approach to arterialize the pedal veins for the treatment of chronic limb-threatening ischemia in subjects ineligible for conventional endovascular or surgical limb salvage procedures.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be ≥ 18 and ≤ 95 years of age
- •Clinical diagnosis of chronic limb-threatening ischemia, defined as any of the following clinical assessments: previous angiogram or hemodynamic evidence of severely diminished arterial inflow of the index limb (e.g., ABI ≤ 0.39, TP / TcPO2 < 30 mm Hg) and
- •Rutherford Classification 5, ischemic ulceration or
- •Rutherford Classification 6, ischemic gangrene
- •Subject has been assessed by the Principal Investigator and determined that no conventional distal bypass, surgical or endovascular therapy for limb salvage is feasible due to either a) absence of a usable pedal artery target (endovascular or surgical approach), or b) the presence of a pedal artery target with absence of a viable single-segment vein in either lower extremity or either arm that could be used for autogenous vein conduit.
- •Proximally, the Target In-flow Artery at the cross-over point must fall within the recommended vessel diameter ranges for the LimFlow stent graft by visual estimation.
- •Subject is willing and able to sign the informed consent form.
- •Subject is enrolled in an acceptable wound care network and has an adequate support network to ensure that subject is compliant with medication regimen and follow-up study visits.
- •Prior to enrollment (7-day window), women of childbearing potential must have a negative pregnancy test.
- •Primary wound is stable (e.g., not rapidly deteriorating and/or showing signs of healing).
- •Stable glycemic control, HbA1C < 10% (<269mg/dL)
- •Subjects requiring dialysis may be included, provided they meet all the following requirements:
- •On dialysis for > 6 months
- •Autologous arteriovenous (AV) fistula or peritoneal access used for hemodialysis
- •Serum albumin > 30 g/liter
- •BMI > 20
排除标准
- •Concomitant hepatic insufficiency, thrombophlebitis in the target limb, or non-treatable coagulation disorder within the past 90 days.
- •Active immunodeficiency disorder or currently receiving immunosuppressant therapy for an immunodeficiency disorder.
- •Prior peripheral arterial bypass procedure above or below the knee which would inhibit proximal inflow to the stent graft.
- •Absence of adequate viable tissue in target foot.
- •Life expectancy less than 12 months.
- •Documented myocardial infarction or stroke within previous 90 days.
- •Active infection (e.g., fever, significantly elevated WBC count >20.0 x 109/L, and/or positive blood culture) at the time of the index procedure that may preclude insertion of a prosthesis or require major amputation (e.g., osteomyelitis proximal to metatarsals).
- •Known or suspected allergies or contraindications to aspirin or P2Y12 inhibitors, heparin, stainless steel, nitinol or contrast agent that cannot be adequately pre-treated.
- •Subject is currently taking anti-coagulants, which in the opinion of the investigator, interferes with the subject's ability to participate in the study (i.e., intermittent interruption of therapy for procedure may compromise subject's safety).
- •Lower extremity vascular disease that may inhibit the procedure and/or jeopardize wound healing (e.g., vasculitis, Buerger's disease, significant edema in the target limb, deep venous thrombus in the target vein, hyperpigmentation, or medial ulceration above the ankle).
- •Significant acute or chronic kidney disease with a serum creatinine of > 2.5 mg/dl in subjects not undergoing dialysis.
- •Severe heart failure (e.g., NYHA Class IV), which in the opinion of the investigator may compromise subject's ability to safely undergo a percutaneous procedure.
- •Any significant concurrent medical, psychological, or social condition, which may significantly interfere with the subject's optimal participation in the study, in the opinion of the investigator.
- •The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
- •Subject is unwilling, unable, or unlikely for cognitive or social reasons to comply with any of the protocol or follow-up requirements.
研究组 & 干预措施
Treated with LimFlow
Experimental
Treatment with the LimFlow Stent Graft System
干预措施: LimFlow Stent Graft System (Device)
结局指标
主要结局
Amputation Free Survival
时间窗: 6 Months
Freedom from major (above-ankle) amputation and death (all-cause mortality)
次要结局
- Change in Rutherford Classification(6 Months)
- Primary Patency(6 Months)
- Primary Assisted Patency(6 Months)
- Secondary Patency(6 Months)
- Limb Salvage(6 Months)
- Technical Success(Intraprocedurally)
- Radiation Exposure(Intraprocedurally)
- Procedural Success(30 Days)
- Freedom from Contrast-Induced Nephropathy(72 hours)
- Procedure Time(Intraprocedurally)
- All Wound Healing(12 Months)
- Contrast Volume(Intraprocedurally)
- Target Wound Healing(12 Months)
- All Wound Area Reduction(12 Months)
- Primary Patency(30 Days)
- Primary Assisted Patency(30 Days)
- Target Wound Healing(3 Months)
- Secondary Patency(30 Days)
- Limb Salvage(30 Days)
- Limb Salvage(3 Months)
- Change in Rutherford Classification(30 Days)
- Change in Rutherford Classification(3 Months)
- Target Wound Healing(30 Days)
- Target Wound Healing(6 Months)
- All Wound Healing(30 Days)
- All Wound Healing(3 Months)
- All Wound Healing(6 Months)
- All Wound Area Reduction(30 Days)
- All Wound Area Reduction(3 Months)
- All Wound Area Reduction(6 Months)
研究者
研究点 (42)
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