NCT00801710已完成不适用
CrossBoss and Stingray Catheter and Entera Guidewire Chronic Total Occlusion (CTO) Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- CTO Crossing Rate
研究概览
简要总结
This study is to determine if the BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire) can facilitate safe and effective placement of a guidewire in the true lumen of coronary vessels distal to a chronic total occlusion (CTO).
The hypothesis is that the BridgePoint Medical System can do this without an increase in major complications.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suitable for coronary intervention
- •de novo or restenotic CTO at least 3 months old, in proximal or mid coronary artery segment, 3.0-5.0 mm in diameter
- •Mild/moderate proximal vessel tortuosity
- •Mild/moderate lesion angulation
- •Mild/moderate calcification
- •Satisfactory distal vessel visualization
- •Mild/moderate side branch interference
- •19 years old
- •LVEF>20%
- •Signed informed consent
排除标准
- •Extensive dissection from guidewire manipulation
- •SVG or in-stent CTO
- •Aorto-ostial CTO
- •Unable to take aspirin, Clopidogrel, or Ticlopidine
- •Thrombus/vessel filling defects
- •Severe cerebrovascular disease/stroke within 1 month
- •Intervention within 2 weeks
- •Renal insufficiency
- •GI bleeding
- •Active infection
- •Life expectancy <2 years
- •Significant anemia
- •Uncontrolled hypertension
- •Severe electrolyte imbalance
- •Anaphylaxis to contrast
- •NYHA class IV
- •Unstable angina requiring intervention
- •MI within 2 weeks
- •Uncontrolled diabetes
- •Participating in another protocol
- •Unwilling/unable to comply with protocol
- •Angina/ischemia caused by target vessel
结局指标
主要结局
CTO Crossing Rate
时间窗: Peri-procedural
次要结局
- Acute myocardial infarction (AMI)(Peri-procedural)
- Perforation rate(Peri-procedural)
- Major Adverse Cardiac Events (MACE)(30 days)
研究者
研究点 (4)
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