Facilitated Antegrade Steering Technique in Chronic Total Occlusions
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 147
- 试验地点
- 16
- 主要终点
- Technical Success
研究概览
简要总结
Prospective, non-randomized, multicenter study in subjects with coronary artery chronic total occlusions (CTOs). Published results of safety and effectiveness of conventional techniques will be used for comparison. Enrollment of up to 149 subjects with a CTO refractory to currently marketed guidewire use and meeting all inclusion/exclusion criteria at up to 15 US clinical sites. Hypothesis is that the BridgePoint Medical System is safe and effective in treating coronary CTOs compared to CTO literature.
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
- •suitable candidate for non-emergent, coronary angioplasty
- •documented coronary CTO lesion with the following characteristics: a) Thrombolysis in Myocardial Infarction (TIMI) 0 flow for at least 90 days; b) satisfactory distal vessel visualization; and c) refractory to currently marketed guidewire crossing via 1 of the following:
- •previous failed attempt to cross CTO within the past 12 months; or
- •unsuccessful CTO crossing w/ guidewire (10-15 min fluoro time); or
- •attempt to cross CTO w/ guidewire results in subintimal guidewire
- •angina or ischemia caused by the occluded artery
- •at least 18 years of age
- •Body Mass Index (BMI) < 40
- •left ventricle ejection fraction > 20%
- •sign the Informed Consent Form
排除标准
- •saphenous vein graft (SVG) CTO or an in-stent CTO
- •aorto-ostial CTO location. (Ostial bifurcation origins may be considered)
- •intolerance to aspirin or a neutropenic response to Ticlopidine/Clopidogrel
- •appearance of thrombus or intraluminal filling defects
- •severe cerebrovascular disease (history of stroke or TIA within 1 month)
- •cardiac intervention within two weeks of the procedure
- •renal insufficiency (serum creatinine of > 2.3 mg/dl)
- •active gastrointestinal bleeding
- •active infection or fever that may be due to infection
- •life expectancy < 2 years due to other illnesses
- •significant anemia (hemoglobin < 8.0 mg / dl)
- •severe uncontrolled systemic hypertension
- •severe electrolyte imbalance
- •anaphylaxis to angiographic contrast media unless appropriately medicated
- •congestive heart failure [New York Heart Association (NYHA) Class IV]
- •unstable angina requiring emergent percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)
- •recent myocardial infarction (MI)(within the past two weeks)
- •uncontrolled diabetes
- •participation in another investigational protocol
- •unwillingness or inability to comply with any protocol requirements
- •pregnant or nursing
- •extensive dissection from refractory guidewire use
- •crossing CTO (true lumen) w/ guidewire within 10-15 min of fluoro time
研究组 & 干预措施
BridgePoint Medical System
Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
干预措施: Recanalization of a coronary chronic total occlusion (Device)
结局指标
主要结局
Technical Success
时间窗: Intraprocedural
Defined as the ability of the BridgePoint Medical System to successfully facilitate placement of a guidewire beyond a chronic total occlusion (CTO) in the true vessel lumen in cases that were otherwise refractory to treatment with a currently marketed guidewire
30-day Major Adverse Cardiac Event (MACE) Rate
时间窗: 30 Days
Defined as cardiac death, Q-wave and non-Q-wave \[total creatinine kinase (CK) \>2x upper limit of normal with a positive myocardial band (MB) fraction\] myocardial infarction (MI), target lesion revascularization (TLR), and emergency bypass surgery.
次要结局
- Total Procedure Time(Intraprocedural)
- Total Procedural Fluoroscopy Time(Intraprocedural)