NCT02198105Unknown不适用
Registry of Cutting Balloon and DCB Intervention in Femoropopliteal Stenosis/Occlusion.
Caritasklinik St. Theresia1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年5月最近更新:
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
- Clinically driven target lesion revascularization (TLR)
研究概览
简要总结
Observational registry including patients with peripheral artery disease due to femoro-popliteal stenosis or occlusion treated with cutting ballon- and subsequent drug-coated-ballon-percutaneous-transluminal-angioplasty (PTA).
详细描述
The registry includes consecutive patients with symptomatic peripheral artery disease due to femoro-popliteal stenosis or occlusion treated with cutting ballon- and subsequent drug-coated-ballon-percutaneous-transluminal-angioplasty (PTA).
Interventional procedure:
- PTA with Cutting-Balloon (60-120 seconds).
- PTA with Drug-Coated-Balloon (60 seconds).
Technical success is defined as
- no recoil >30%
- no dissection >Type B
- no stenting >30% of lesion length.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •peripheral artery disease (PAD) with femoro-popliteal stenosis >70% or occlusion (vessel diameter 4-6mm)
- •age 18-99
- •informed consent
排除标准
- •proximal / iliacal stenosis
- •stenosis/occlusion of all arteries below the knee
结局指标
主要结局
Clinically driven target lesion revascularization (TLR)
时间窗: 6 months
clinically driven target lesion revascularization
次要结局
- Binary restenosis(12 months)
- clinically driven target vessel revascularization (TVR)(12 months)
- Change in Ankle Brachial Index (ABI)(12 months)
- Change in Rutherford-classification(12 months)
- Amputation(12 months)
- major cardiac adverse events(12 months)
- Clinically driven target lesion revascularization (TLR)(12 months)
研究者
Magnus Baumhäkel
PD Dr. med. Magnus Baumhäkel
Caritasklinik St. Theresia
研究点 (1)
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