NCT03987061进行中（未招募）不适用
Physician-initiated Trial Investigating the MOTIV™ Bioresorbable Scaffold (Reva Medical) for the Treatment of Below-The-Knee Artery Disease
Dr. Sabrina Overhagen8 个研究点 分布在 2 个国家目标入组 58 人开始时间: 2019年9月5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
- 58
- 试验地点
- 8
- 主要终点
- safety endpoint - rate of serious device-related adverse events within 30 days post-op
研究概览
简要总结
The objective of this clinical evaluation is to evaluate the immediate and long-term (up to 36 months) outcome of the MOTIV™ Bioresorbable Scaffold (Reva Medical) in a controlled prospective investigation for the treatment of patients with rest pain or minor tissue loss (CLI) due to the presence of lesions of max 100mm in length at the level of the below-the-knee arteries.
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 willing to comply with specified follow-up evaluations at the specified times
- •Patient presenting with rest pain or minor tissue loss (Rutherford classification from 4 to 5)
- •Patient is >18 years old
- •Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study - Patient has a projected life-expectancy of at least 24-months
- •Patient is eligible for treatment with the MOTIV™ Bioresorbable Scaffold
- •Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure
- •De novo lesion or Restenotic lesion after PTA in the infrapopliteal arteries, suitable for endovascular therapy
- •Target vessel diameter visually estimated to be ≥2.5mm and ≤3.50mm
- •Guidewire and delivery system successfully traversed the lesion
- •Total target lesion is maximally 100mm
- •Definition of Target Lesion is:
- •short de novo or Restenotic lesion after PTA or
- •a short residual flow-limiting dissection or restenosis after PTA of a longer lesion
排除标准
- •The reference segment diameter is not suitable for the available stent design
- •Untreated flow-limiting aortoiliac stenotic disease
- •Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment.
- •Any previous surgery in the target vessel
- •Aneurysm located at the target vessel
- •Non-atherosclerothic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
- •Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 2-year life expectancy.
- •Major distal amputation (above the transmetatarsal) in the study or non-study limb.
- •Septicemia or bacteremia
- •Any previously known coagulation disorder, including hypercoagulability
- •Contraindication to anticoagulation or antiplatelet therapy
- •Known allergies to scaffold or scaffold components
- •Known allergies to contrast media that cannot be adequately premedicated prior to the study procedure
- •Patient with known hypersensitivity to heparin-induced thrombocytopenia (HIT) type II
- •Currently participating in another clinical research trial
结局指标
主要结局
safety endpoint - rate of serious device-related adverse events within 30 days post-op
时间窗: 30 days post-op
Proportion of subjects who experience serious device-related adverse events within 30 days post-procedure.
efficacy endpoint - Primary Patency rate at 12-months post-op
时间窗: 12 months post-op
Primary patency defined as no evidence of at least 50% restenosis or reocclusion within the originally treated lesion based on color-flow-duplex ultrasound (CFDU) measuring a peak systolic velocity ratio ≤2.5, and/or angiography (left at the discretion of the investigator) without target lesion revascularization (TLR) within 12 months.
次要结局
- Technical Success(1-day post-op)
- Primary Patency rate at follow-up visits(1 month, 6 months, 12 months, 24 months and 36 months post-op)
- Clinically-driven target lesion revascularization (TLR) at 1, 6, 12, 24 and 36-months(1 month, 6 months, 12 months, 24 months and 36 months post-op)
- Limb-Salvage rate at follow-up visits(1 month, 6 months, 12 months, 24 months and 36 months post-op)
- Clinical success at follow-up visits(1 day post-op and 1 month, 6 months, 12 months, 24 months and 36 months post-op)
- Serious adverse events during the study (within 36 months post-op)(within 36 months post-op)
研究者
Dr. Sabrina Overhagen
Director
FCRE (Foundation for Cardiovascular Research and Education)
研究点 (8)
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