NCT00751283撤回2 期
Minnow Medical GRST Peripheral Catheter System First-in-Man Study Radiofrequency for the Treatment of Peripheral Vascular Occlusive Disease of the Lower Extremities
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Major adverse clinical events rate
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the Minnow Medical GRST Peripheral Catheter System in the treatment of new lesions in the superficial femoral artery or the popliteal artery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 ≥18 years of age
- •Patient is Rutherford category 2-4
- •De novo lesion in the SFA or popliteal artery with a diameter stenosis ≥50%
- •Target lesion is a de novo occlusion that can be successfully pre-dilated resulting in a lesion of <99%
- •Target lesion stenosis has a length of ≤100 mm based on visual assessment
- •Target vessel reference diameter is ≥3.0 mm and ≤7.0 mm based on visual assessment
- •Angiographic evidence of distal runoff defined as minimum one (1) patent tibial artery with a straight flow to the foot
- •Patient is willing and able to provide written informed consent prior to any study specific procedure
- •Patient is willing and able to comply with specified follow-up evaluations at the specified times
排除标准
- •Any prior intervention in the intended target lesion including 10 mm proximal or distal from the intended treatment area
- •Evidence of thrombus in the target vessel
- •Prior ipsilateral or contralateral lower limb arterial bypass
- •Treatment of ipsilateral lesions during the index procedure or planned treatment after the index procedure
- •Target lesion is severely calcified
- •Any known allergies and / or intolerances to the following: ASA, Clopidogrel, Heparin, contrast agents (that cannot be adequately pre-medicated).
- •Any planned surgery within 30 days of the study procedure.
- •Renal failure (serum creatinine > 2.0 mg/dL)
- •Female with childbearing potential without a negative pregnancy test
- •Patient has had an organ transplant
- •Patient is currently participating in an investigational drug or device study which has not reached the primary endpoint yet or which clinically interferes with the endpoints of this study
- •In the investigator's opinion, the patient has a severe co-morbid condition(s) that could limit the ability to participate in the study
结局指标
主要结局
Major adverse clinical events rate
时间窗: Up to 30 days
次要结局
- Binary restenosis(30 days, 3 months, 6 months)
- Target lesion revascularization(30 days, 3 months, 6 months)
- Amputation rate(30 days, 3 months, 6 months)
- Technical success(Treatment)
- Serious adverse events rate, including major adverse clinical events(30 days, 3 months, 6 months)
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