NCT05455021进行中（未招募）不适用
Feasibility Study of the Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Popliteal Artery (PA) After Sub-optimal Percutaneous Transluminal Angioplasty (PTA) or Atherectomy: REACTIVATE I
Alucent Biomedical2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年11月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- An acute reduction in arterial dissections
研究概览
简要总结
Feasibility Study of the Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Popliteal Artery (PA) after Sub-optimal percutaneous transluminal angioplasty (PTA) or Atherectomy: REACTIVATE I
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Subjects for this study must meet all of the following general eligibility criteria
- •AND the answer must be "YES" to all general inclusion criteria:
- •Subject (or Legal Guardian) is willing and able to provide consent before any study-specific tests or procedures are performed and agree to attend all required follow-up visits.
- •Male or female subject of at least 18 years of age.
- •Chronic symptomatic lower limb ischemia defined as Rutherford classification 2, 3, or
- •Has screen failed from the ACTIVATE II study due to the presence of Grade C or D dissection(s).
排除标准
- •Life expectancy, documented in the Investigator's opinion, of less than 1 year.
- •Cerebrovascular accident (CVA) or transient ischemic attack (TIA) or cardiac event (e.g., PCI for STEMI/NSTEMI, unstable angina) within 6 months prior to the index procedure.
- •Chronic renal insufficiency with serum creatinine ≥ 2.5 mg/dL or eGFR <45 ml/min within 30 days prior to the index procedure or treatment with peritoneal or hemodialysis.
- •Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3 within 30 days prior to the index procedure or has a history of bleeding diathesis.
- •Receiving oral or intravenous immunosuppressive therapy.
- •Subject has white blood cell (WBC) count < 3.0 (3,000 cells/mm3) within 30 days prior to the index procedure.
- •History of major amputation in the target limb.
- •Any major intervention planned at the index procedure or within 30 days post-index procedure including treatment of contralateral limb.
- •Subject is pregnant, breastfeeding, or planning to become pregnant in the next 30 days. Subjects (male and female) of childbearing potential must agree to use effective birth control measures for 30 days after the index procedure.
结局指标
主要结局
An acute reduction in arterial dissections
时间窗: 12 months
Reduction in arterial dissection(s) of at least one grade.
Primary Patency as assessed by Doppler Ultrasound (DUS) and freedom from CD-TLR at 1 Year
时间窗: 12 months
Primary Patency as assessed by Doppler Ultrasound (DUS)
次要结局
- Clinical Success(36 months)
- Procedural Success(12 months)
- Safety Measure(72 months)
- Rutherford Classification(36 months)
- Technical Success(12 months)
- Hemodynamic Improvement(36 months)
- Quality of Life Measure(72 months)
研究者
研究点 (2)
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