A Non-Randomized Clinical Study Evaluating Use of the CapBuster System Medical Device for the Crossing of Chronic Total Occlusions in Coronary Arteries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 主要终点
- CTO crossing of the targeted chronic total occlusion
研究概览
简要总结
Evaluate the safety and effectiveness of the CapBuster System medical device in crossing de novo or restenotic chronic total occlusions in coronary arteries
详细描述
Primary Efficacy Endpoints:
Successful crossing of the targeted chronic total occlusion, defined as angiography confirmed guidewire placement in the true lumen without utilization of a re-entry device.
The effectiveness endpoint is designed to demonstrate successful crossing of the chronic total occlusion in at least 80% of lesions.
Primary Safety Endpoints:
Freedom from CapBuster System related clinically significant perforation, embolization, or dissection, defined as perforations or embolization that require intervention and flow-limiting (type C, D, E) dissections.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males > 18 years of age and Female patients of non child-bearing potential
- •Clinical diagnosis of coronary arterial disease requiring revascularization as evidenced by Duplex UltraSound, Digital Subtraction Angiography, CT angiography, or MR angiography
- •Subject requires single- or multi-vessel percutaneous coronary intervention (PCI) of de novo or restenotic target lesion (including in-stent restenotic lesions).
- •Subject's lesion(s) is (are) amenable to stent treatment with currently available CE or FDA-approved stents.
- •Presence of coronary arterial de novo or restenotic chronic total occlusion (100% stenosis), with TIMI 0 flow, confirmed by angiography. Vessel distal to the occlusion(s) must be visualized per collateral or retrograde flow. A maximum of 1 target occlusions can be treated per patient. Target occlusion(s) can be in-stent restenosis
- •Target vessel(s) must be ≥ 2.5 mm and ≤ 3.25 mm in diameter proximal to the target occlusion(s) by visual estimate
- •In the opinion of the investigator, life expectancy of > 1 year
- •Willing and able to sign the informed consent form
排除标准
- •Target occlusion is within a bypass graft
- •acute coronary syndrome with ST elevation,
- •cardiogenic shock or out of hospital cardiac arrest
- •Subject has signs or symptoms of systemic infection/sepsis (temperature ≥38.0o Celsius and WBC ≥12,000 cells/uL). If subject has localized infection, including cellulitis or osteomyelitis, or infection is adequately treated and controlled, per investigator discretion, patient may be enrolled.
- •Known or suspected myocardial infarction or stroke within previous 30 days
- •Currently participating in another investigational drug or device study
- •Female patients of child-bearing potential.
- •Evidence of STEMI within 72 hours of the intended treatment on infarct related or non-infarct related artery.
- •Cardiogenic shock on presentation or during current hospitalization.
- •Known allergies or contraindication to: contrast materials, antiplatelet therapy, aspirin, clopidogrel (Plavix) and ticlopidine (Ticlid), heparin, bivalirudin, stainless steel, or contrast agent (which cannot be adequately premedicated).
- •Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials).
- •Stroke or transient ischemic attack within the prior 3 months.
- •Any target vessel that has evidence of excessive thrombus (e.g. requires target vessel thrombectomy).
- •Any target vessel that has evidence of excessive tortuousity (greater than 60 degree angle) that makes it unsuitable for proper stent delivery and deployment,
- •Any target lesion that requires treatment with a device other than percutaneous transluminal coronary angioplasty (PTCA) prior to stent placement (e.g. but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
研究组 & 干预措施
Patients with the presence of coronary arterial de novo or restenotic chronic total occlusion.
Successful crossing of the targeted chronic total occlusion, defined as angiography confirmed guidewire placement in the true lumen without utilization of a re-entry device.
干预措施: CapBuster System Medical Device for the Crossing of Chronic Total Occlusions in Coronary Arteries (Device)
结局指标
主要结局
CTO crossing of the targeted chronic total occlusion
时间窗: 30 day follow-up
Successful crossing of the targeted chronic total occlusion, defined as angiography confirmed guidewire placement in the true lumen without utilization of a re-entry device.
CapBuster System related clinically significant events
时间窗: 30 day follow-up
Freedom from CapBuster System related clinically significant perforation, embolization, or dissection, defined as perforations or embolization that require intervention and flow-limiting (type C, D, E) dissections.
次要结局
- Study procedure(30 day follow-up)