NCT01478061已完成4 期
Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device
Cardica, Inc13 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2009年4月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 13
- 主要终点
- Graft patency rates for coronary revascularization when in general use in the United States compared to hand-sewn anastomoses.
研究概览
简要总结
The Study plan is a post-market prospective, multi-center, open-label registry. The vein graft failure rates for the currently commercialized C-Port devices will be compared to an a priori rate taken from the peer-reviewed literature.
详细描述
To satisfy the requirements set forth in post-market surveillance orders issued by the US FDA to Cardica, Inc., the following outcomes will be evaluated:
- Acute, midterm, and one-year graft failure rates for coronary revascularization using the C-Port® xA™ Distal Anastomosis System, C-Port® FlexA™ Distal Anastomosis System, and C-Port® XCHANGE™ Distal Anastomosis System when in general use in the United States compared to hand-sewn anastomoses.
- Technical failure rates when attempting to complete an anastomosis using the C-Port xA, FlexA, and XCHANGE Distal Anastomosis Systems.
- The technical success rate of hand-sewn anastomoses following technical failures of the C-Port devices and the hand-sewn graft patency rates and clinical sequelae at one year.
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
- •Able to give informed consent.
- •Willing and able to have follow-up visits and examinations.
- •Less than 80 years old.
- •Have an ejection fraction of >30 %.
- •Have a life expectancy of >1 year.
- •Pre-Operative
排除标准
- •Currently participating in other clinical trials that would conflict with this protocol.
- •Unable to meet study requirements.
- •Currently pregnant.
- •Require preoperative use of an intraaortic balloon pump.
- •Have a history of a bleeding disorder or history of a thromboembolic disease requiring anticoagulation therapy.
- •Have congestive heart failure or been classified as NYHA Class IV.
- •Have an aspirin allergy or other contraindications to aspirin use.
- •Previous coronary artery bypass surgery.
- •Vasculitis or other nonatherosclerotic cause for coronary artery disease.
- •Intra-Operative Exclusion Criteria:
- •At least one target vessel site where the C-Port anastomosis will be placed that is free from severe calcification or severe atheromas
- •Target vessel wall properties where the C-Port anastomosis will be placed are suitable for hand-sewn anastomosis
- •Target vessel diameter is ≥ 1.3 mm
- •Target vessel has a single wall thickness ≤ 0.75mm
- •Hemodynamically stable
结局指标
主要结局
Graft patency rates for coronary revascularization when in general use in the United States compared to hand-sewn anastomoses.
时间窗: 12 months
a. Acute, midterm, and one-year graft patency rates for coronary revascularization when in general use in the United States compared to hand-sewn anastomoses.
次要结局
- Technical Failure Rates(Day 1)
- Technical success rate of hand-sewn(Day 1 and 12 months)
研究者
研究点 (13)
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