NCT00670436已完成2 期
The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions
University of Ulm4 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2008年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Late loss
研究概览
简要总结
The aim of the study is to assess the safety and efficacy of a Paclitaxel-eluting PTCA-balloon in combination with bare-metal stenting for treatment of chronic total occlusions in native coronary arteries with reference diameters between 2.5 mm and 4.0 mm.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic total occlusion
- •Thrombolysis in Myocardial Infarction (TIMI) flow 0 or 1
- •occlusion in native coronary artery
- •indication for percutaneous coronary intervention based on symptoms, prognosis or evidence of ischemia
- •reference diameter 2.5 mm to 4.0 mm
排除标准
- •saphenous vein graft
- •bifurcation lesion with need to stent main and side branch
- •left main occlusion
- •de-novo stenosis (no occlusion)
- •restenosis
- •in-stent restenosis
- •contraindication for dual antiplatelet therapy with acetylsalicylic acid and clopidogrel for 6 months
- •coronary aneurysm at target lesion
结局指标
主要结局
Late loss
时间窗: 6 months
次要结局
- percent diameter stenosis(6 months)
- late loss index(6 months)
- target vessel revascularization(30 days, 6, 12, 24 months)
- major adverse cardiac events(30 days, 6, 12, 24 months)
- binary angiographic restenosis rate(6 months)
- Target lumen revascularization(30 days, 6, 12, 24 months)
研究者
Jochen Wohrle
Prof. Dr. Jochen Wöhrle
University of Ulm
研究点 (4)
Loading locations...
相似试验
已完成
2 期
P E P C A D II, The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat In-Stent RestenosesIn-Stent RestenosisNCT00393315University Hospital, Saarland120
已完成
2 期
PEPCAD I. The Paclitaxel-Eluting PTCA-Balloon Catheter to Treat Small VesselCoronary StenosisNCT00404144Heart Centre Rotenburg120
已完成
4 期
The Paclitaxel-Eluting Percutaneous Coronary Angioplasty (PTCA)-Balloon Catheter for the Treatment of Coronary BifurcationsAngioplastyNCT01180517Ralf Degenhardt, PhD64
已完成
1 期
DEBlue Stent vs Cypher Stent in the Treatment of Advanced Coronary Artery DiseaseCoronary Artery DiseaseNCT00473772University Hospital, Saarland643
Unknown
4 期
Efficacy and Safety of Paclitaxel-eluting Balloon for Treatment of Lesions in Native Small Coronary ArteriesCoronary Artery DiseaseNCT01903902Gachon University Gil Medical Center1,000