VIOLA PMS Clinical Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Technical success of the VIOLA device
研究概览
简要总结
The goal of this post marketing surveillance clinical trial is to learn about VIOLA as a proximal seal device in patients undergoing coronary artery grafting (CABG) surgery. The main objective is to evaluate the clinical safety and performance of the VIOLA. Participants will be treated with routine CABG with use of VIOLA for maintaining hemostasis when suturing the proximal anastomosis. Patients will be followed for any clinical events at 6 weeks and 9 months post surgery.
详细描述
The goal of this post marketing surveillance clinical trial is to collect post market data on the safety and performance of VIOLA as a proximal seal device in patients undergoing coronary artery grafting (CABG) surgery. The main objective is to evaluate the clinical safety and performance of the VIOLA. Participants will be treated with routine CABG with use of VIOLA for maintaining hemostasis when suturing the proximal anastomosis. Data will be collected intraoperatively, at discharge, at 6 weeks, and at 9 months post CABG.
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
- •Patient scheduled for isolated CABG on clinical grounds
- •One or more bypass grafts originating from the aorta
- •Ability to give their informed written consent
- •Ability and willingness to comply with study follow up requirements
- •Patient is ≥ 18 years of age
排除标准
- •Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)
- •Prior clinical stroke less than one year before surgery
- •Pre-operative neurological deficits
- •Chronic atrial fibrillation
- •Aortic external diameter less than 25 mm measured intraoperatively
- •No proximal aortic anastomosis eligible for VIOLA use, assessed intraoperatively according to surgeon's discretion (E.G inadequate punch size, thin-walled aorta).
- •Symptomatic carotid disease
- •Acute MI within 24 hours of planned surgery
- •EuroScore II ≥ 4
- •Known allergy to nickel
- •Women of child bearing age
- •Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
结局指标
主要结局
Technical success of the VIOLA device
时间窗: Acute, intraoperative
Proportion of proximal anastomoses that were completed without use of an aortic clamp
次要结局
- Sealing quality(Acute, intraoperative)
- Ease of proximal anastomosis suturing(Acute, intraoperative)