NCT03847233已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 10
- 主要终点
- Number of Patients With Lesion Success
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the Jetstream Atherectomy System for the treatment of Japanese patients with symptomatic occlusive atherosclerotic lesions in native superficial femoral artery (SFA) and/ or proximal popliteal arteries (PPA).
详细描述
A prospective, multicenter, single-arm trial evaluating the safety and efficacy of the Jetstream Atherectomy System in the treatment of symptomatic occlusive atherosclerotic lesions ≤150 mm in length located in the femoropopliteal arteries in subjects with symptoms classified as Rutherford categories 2-4.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2-4
- •Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA of which meet the following criteria:
- •Severely calcified lesions with degree of stenosis ≥70%
- •Vessel diameter ≥3.0 mm and ≤6.0 mm
- •Total lesion length (or series of lesions) ≤150 mm
排除标准
- •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 <80,000mm3 or >600,000mm3 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
结局指标
主要结局
Number of Patients With Lesion Success
时间窗: during procedure
次要结局
未报告次要终点
研究者
研究点 (10)
Loading locations...
相似试验
已完成
不适用
Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME)Peripheral Arterial DiseaseNCT02733653Boston Scientific Corporation60
已完成
不适用
JET-RANGER Trial - JETStream Atherectomy With Adjunctive Paclitaxel-Coated Balloon Angioplasty vs Plain Old Balloon Angioplasty Followed by Paclitaxel-Coated BalloonPeripheral Vascular DiseaseNCT03206762Midwest Cardiovascular Research Foundation47
已完成
不适用
JetStream Atherectomy for the Treatment of In-stent RestenosisFemoropopliteal In-stent RestenosisNCT02730234Midwest Cardiovascular Research Foundation60
已完成
不适用
Kaitoh Atherectomy FIHPeripheral Arterial DiseaseNCT05873452Terumo Medical Corporation9
撤回
不适用
Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity ArteriesPeripheral Arterial DiseaseNCT02126540Avinger, Inc.