A Prospective, Multicenter, Single-arm Clinical Trial of Jetstream Atherectomy System for the Treatment of Japanese Patients with Symptomatic Occlusive Atherosclerotic Lesions in the Superficial Femoral and/ or Proximal Popliteal Arteries - Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME II)

Boston Scientific Japan K.K.0 个研究点目标入组 31 人开始时间: 2019年3月1日最近更新: 2023年10月17日

适应症

试验速览

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•- Target lesion/vessel with in-stent restenosis - History of major amputation in the target limb - Subject has a history of coagulopathy or hypercoagulable bleeding disorder - Subject with untreatable hemorrhagic disease or platelet count <80,000 mm^3 or >600,000 mm^3 as baseline assessment. - History of myocardial infarction, or stroke/cerebrovascular accident (CVA) within 6 months prior to study enrollment - Unstable angina pectoris at the time of the enrollment - Septicemia at the time of enrollment - Presence of other hemodynamically significant outflow lesions in the target limb requiring a planned surgical intervention or endovascular procedure within 30 days after the index procedure - Presence of aneurysm in the target vessel - Acute ischemia and/or acute thrombosis of the SFA/PPA prior to the index procedure - Perforated vessel as evidenced by extravasation of contrast media prior to the index procedure

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