NCT01646801Unknown不适用
The Use of NMB Drug Ejecting Balloon for Treatment of Patients With Peripheral Arterial Disease
N.M.B. Medical Applications Ltd1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Late Lumen Loss (LLL)
研究概览
简要总结
The purpose of this study is to demonstrate the Safety and effectiveness of the use of NMB's drug ejecting balloon for the treatment of de novo and restenotic lesions in peripheral arterial disease.
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
- •Patients 18 years old or older
- •Patient with lifestyle limiting claudication or rest pain (Rutherford- Becker scale 2, 3 or 4).
- •Patient with de novo lesion or restenotic lesion ≥70% in the iliac, femoral, popliteal or tibial artery.
- •The target lesion can be successfully crossed with a guide wire and dilated.
- •The target lesion is in a native artery of 2.5-10mm in diameter and less than 80 mm in length.
- •Patient is willing to and able to sign a written informed consent and to comply with procedures (e.g., adherence to follow-up visits, including 6 months CT-angiography/MRA follow-up).
排除标准
- •Women who are pregnant or breast-feeding and women of childbearing potential who do not use adequate contraception.
- •Previous participation in another study with any investigational drug or device within the past 30 days.
- •The patient is currently enrolled in another investigational device or drug trial.
- •Severe reaction to contrast agents that cannot be adequately premedicated prior to procedure.
- •Stenosis with corresponding thrombosis treated within 7 days before enrollment.
- •Patient with known contraindications for aspirin or other anticoagulant/antiplatelet therapy.
- •Patient that has co-morbid illness that may result in life expectancy of less than 12 months.
- •History of haemorrhagic stroke or gastro-intestinal bleeding within 6 months.
- •Patient with major surgery during the 30 days preceding the interventional procedure.
结局指标
主要结局
Late Lumen Loss (LLL)
时间窗: 6 months
Late Lumen Loss (LLL) defined as the difference between the minimal luminal diameter after the procedure and at 6 months, as evaluated by Quantitative Angiography (mm units will be used)
次要结局
- Restenosis rate(6 months)
- Device Malfunction(intraprocedural, 3, 6 and 12 months)
- Adverse events(intraprocedural, 3, 6 and 12 months)
研究者
研究点 (1)
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