NCT01273623已完成4 期
A Prospective, Single-Arm Study to Evaluate the Effects of the Jetstream G3 System on Calcified Peripheral Vascular Lesions
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 10
- 主要终点
- Luminal Area Change
研究概览
简要总结
To investigate the treatment effects with the Jetstream G3 System in moderate to severely calcified peripheral artery disease in the common femoral, superficial femoral or popliteal arteries using intravascular ultrasound (IVUS).
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is ≥ 18 years of age.
- •Patient has claudication determined to be due to femoropopliteal lesion(s) requiring revascularization.
- •The target lesion(s) is/are located in the common femoral, superficial femoral or popliteal arteries.
- •The reference vessel lumen (proximal to target lesion) is ≥ 3.0mm.
- •The patient is an acceptable candidate for percutaneous intervention using the Jetstream G3 System in accordance with its labeled indications and instructions for use.
- •The patient has signed approved informed consent.
- •Moderate or severe vessel obstructive intraluminal calcification as demonstrated by IVUS and angiography.
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 distal runoff vessels.
- •Deep wall calcium.
- •Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
- •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 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 is pregnant or nursing a child.
- •Intended interventional treatment includes planned laser, brachytherapy or atherectomy procedure other than the Jetstream G3 System.
结局指标
主要结局
Luminal Area Change
时间窗: Day 0
lumen area change as measured by intravascular ultrasound (IVUS)
次要结局
- Adjunctive Therapy Use(Day 0)
- Residual Diameter Stenosis(Day 0)
研究者
研究点 (10)
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