NCT06311773Enrolling By Invitation不适用
Pivotal Multicenter Trial of the Boomerang® Catheter for Percutaneous Deep Vein Arterialization (pDVA)
Aveera Medical, Inc.27 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年4月16日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 120
- 试验地点
- 27
- 主要终点
- Amputation Free Survival (AFS)
研究概览
简要总结
The purpose of this study is to establish the safety and effectiveness of the Boomerang Catheter for percutaneous Deep Venous Arterialization (pDVA) to treat no-option Chronic Limb-Threatening Ischemia.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is age ≥ 18 years
- •Patient has confirmed clinical diagnosis of Rutherford Category (RC) 5 or 6 Chronic Limb-Threatening Ischemia (CLTI) with previous angiogram or hemodynamic evidence (e.g., ABI ≤ 0.39, TP / TcPO2 < 30 mm Hg) demonstrating severely diminished arterial perfusion of the index limb.
- •Assessment by the PI and an Independent Review Committee (IRC) determines that patient has no option for conventional distal bypass, surgical or endovascular therapy for limb salvage.
- •Inflow artery criteria:
- •Imaging confirmation of patent inflow artery (< 50% stenosis) from Aortic bifurcation to tibial trifurcation.
- •Target conduit vein criteria:
- •Duplex ultrasound confirms that vein is free from thrombus, contiguous from the intended anastomosis site through the lateral plantar vein, and ≥ 2.0mm lumen-lumen diameter (with tourniquet applied) throughout.
- •Patient may be scheduled for a planned minor amputation (toe, ray, or trans-metatarsal) within 30 days after index procedure.
- •Prior stent(s) to inflow arteries (i.e., Iliac, SFA, Popliteal) are allowed.
- •Patient is willing and able to provide written informed consent.
- •Patient meets institutional criteria for procedure clearance and is able to comply with study requirements per PI judgement.
- •Diabetic patients have adequate glycemic control per investigator judgement.
- •Female patients of childbearing potential have a negative pregnancy test within 7 days prior to index procedure (urine)
- •Patient is enrolled in a wound care network and has an adequate support network to ensure compliance with medication regimen and follow-up study visits.
- •PI determines that the primary wound is stable (e.g., not rapidly deteriorating or showing signs of healing).
排除标准
- •Life expectancy < 12 months.
- •Patient has a 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).
- •Patient is dialysis dependent.
- •Significant acute or chronic kidney disease with a serum creatinine of > 2.5 mg/dl in patients not undergoing dialysis.
- •Prior peripheral arterial bypass procedure on index limb within 30 days.
- •Previous major amputation of the target limb or absence of adequate viable tissue for below-ankle (e.g., mid-foot) amputation.
- •Patient is non-ambulatory due to above-ankle amputation of contralateral limb.
- •The patient is currently participating in another investigational drug or device study that has not completed the primary endpoint and that clinically interferes with the endpoints of this study per PI judgement.
- •Patient has known hypersensitivity or contraindication to materials used during the procedure (cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers) or a known contrast sensitivity that cannot be adequately pre-medicated.
- •Patient cannot be adequately treated with study medications due to known contraindication to aspirin, ADP antagonists such clopidogrel, prasugrel or ticagrelor, or anticoagulants such as heparin or bivalirudin.
- •Patient has had a stroke within the previous 3 months with residual Rankin score of ≥
- •NYHA Class IV heart failure which may compromise patient's ability to safely undergo a percutaneous procedure, per PI judgment.
研究组 & 干预措施
Treated with Boomerang Catheter
Experimental
干预措施: Boomerang Catheter (Device)
结局指标
主要结局
Amputation Free Survival (AFS)
时间窗: 6-months
Freedom from above-ankle amputation of the index limb or death (any cause) at 6 months, compared to a literature derived performance goal.
次要结局
- Secondary patency(1 year post index procedure)
- Technical success(During index procedure)
- Procedural success(Immediately post index procedure)
- Limb salvage(3 years post index procedure)
- Target wound healing(1, 3, 6, 9-months, and 1-year)
- Complete wound healing(1, 3, 6, 9-months, and 1-year)
- Primary assisted patency(1 year post index procedure)
- Primary patency(1 year post index procedure)
研究者
研究点 (27)
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