NCT02072239已完成不适用
First-In-Human Study to Demonstrate the Preliminary Safety and Efficacy of the Angioshield System to Provide Mechanical Support for Vein Grafts Used in CABG Surgery
Neograft Technologies, Incorporated1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2014年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- MACE
研究概览
简要总结
The purpose of this study is to determine whether or not the Angioshield device can be safely applied to support saphenous vein grafts used in standard coronary bypass surgery.
详细描述
\This is a first in human study which is intended to determine if a larger pivotal study is justified.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject will be eligible for inclusion in the investigation if he/she:
- •is between the ages of 18 and 80 years of age, inclusive
- •requires Coronary Atery Bypass Graft (CABG) surgery with minimum of one SVG used to bypass a stenosis in the Right Coronary, the Circumflex, a Diagonal, or an Obtuse Marginal artery, due to atherosclerotic coronary artery disease
- •is able to give their informed written consent
- •is willing and able to complete all follow-up visits and procedures
排除标准
- •Subject will be excluded from participation in the investigation if he/she:
- •is currently enrolled in another clinical investigation
- •is unable to tolerate or comply with required post-surgical medications or imaging (e.g., anticoagulation regimen; or known allergy to contrast agent)
- •is or may be pregnant or is lactating, or plans to become pregnant in the next 12 months
- •shows a presence of hypercoagulable state or history of idiopathic venous or arterial thrombosis
- •has had an acute MI within the last 21 days
- •has had a previous CABG
- •requires emergency surgery
- •has a left ejection fraction (LEF) less than 20%
- •has a target vessel stenosis of less than 70%
- •has a transmural infarct of the target artery territory
- •currently requiring dialysis
- •is having concomitant-surgery of any kind
- •has varicose veins
- •has had previous saphenectomy
结局指标
主要结局
MACE
时间窗: 30 days
The primary objective of this study is to provide acute and subacute (up to 30 days) safety outcomes to support expansion to a pivotal study involving a larger subject population. All Major Adverse Cardiac Events (MACE), defined as the composite of cardiac death, myocardial infarction (Q-wave and non-Q wave), and target vessel revascularization, will be evaluated at 30 days post-operative.
次要结局
- MACE and Graft Patency(30, 90 and 365 Days)
研究者
研究点 (1)
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