NCT01436435已完成4 期
Jetstream NAVITUS™ System Endovascular Therapy Post-market Registry (JET)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 22
- 主要终点
- Binary Restenosis
研究概览
简要总结
The scope of the JET registry to observe long term treatment effects of Jetstream Navitus on various lesions types/morphologies.
详细描述
- To observe the treatment effects of the Jetstream NAVITUS System in long, occluded, diffuse, thrombotic or calcified lesions in peripheral arterial disease of the common femoral, superficial femoral, or popliteal arteries.
- To assess and quantify vessel patency 1 year post atherectomy treatment.
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 ≥ 18 years of age.
- •The target de novo or restenotic Percutaneous Transluminal Angioplasty (PTA) lesion(s) is/are located in the common femoral, superficial femoral or popliteal arteries.
- •The reference vessel lumen (proximal to target lesion) is ≥ 4.0mm.
- •Evidence of ≥ 70% stenosis or occlusion confirmed by angiography.
- •Guidewire must cross lesion(s) within the true lumen, without a sub-intimal course before the patient is considered as entered into the study.
- •Patient is an acceptable candidate for percutaneous intervention using the Jetstream NAVITUS System in accordance with its labeled indications and instructions for use.
- •Lesion length ≥ 4cm.
- •Patient has a Rutherford category score of 1-
- •Patient has signed approved informed consent.
- •Patient is willing to comply with the follow-up evaluations at specified times.
排除标准
- •Patient has an uncontrollable allergy to nitinol, stainless steel or other stent materials or to contrast agent.
- •Patient is unable to take appropriate anti-platelet therapy.
- •Patient has no patent distal runoff vessels.
- •Patient has critical limb ischemia (i.e., Rutherford class 4-6)
- •Limited vascular access that precludes safe advancement of the Jetstream NAVITUS System to the target lesion(s).
- •Interventional treatment is intended for in-stent restenosis.
- •Patient has target vessel with moderate or severe angulation (e.g., >30 degrees) or tortuosity at the treatment segment.
- •Patient has a history of coagulopathy or hypercoagulable bleeding disorder.
- •Patient is receiving hemodialysis or has significantly impaired renal function (creatinine is > 2.5 mg/dl) at the time of treatment.
- •Patient has evidence of intracranial or gastrointestinal bleeding within the past 3 months.
- •Patient has had severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days.
- •Patient has had surgical or endovascular procedure in the same vascular territory within 30 days prior to the index procedure.
- •Patient has any planned surgical intervention or endovascular procedure within 30 days after the index procedure.
- •Use of another debulking device during the index procedure prior to the Jetstream NAVITUS System will exclude the patient.
结局指标
主要结局
Binary Restenosis
时间窗: 12 months
Percentage of patients with binary restenosis at 12 months as defined by duplex ultrasound derived systolic velocity ratio \>2.5. Binary restenosis will be measured by duplex ultrasound technology.
次要结局
- Major Adverse Events (MAE)(30 days)
- Procedural Success(Index Procedure)
- Ankle-Brachial Index (ABI)(12 months)
研究者
研究点 (22)
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