NCT02476318已完成不适用
A Study to Evaluate the Safety and Performance of ArterX™ Vascular Sealant in Sealing Synthetic Arterial Grafts
Tenaxis Medical, Inc.3 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2007年6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
- 32
- 试验地点
- 3
- 主要终点
- Number of anastomoses with immediate sealing of the suture line
研究概览
简要总结
A prospective, multi-center study to evaluate the safety and performance outcomes of the ArterX Vascular Sealant when used for prophylactic sealing of suture lines at the anastomosis between native vessel and synthetic vascular grafts.
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
- •The subject must be ≥ 18 years old
- •The subject must be scheduled for surgical placement of a synthetic graft for large vessel repair/ arterial reconstruction/ hemodialysis access.
- •The subject has no child bearing potential or has a negative serum or urine pregnancy test within 7 days of the index procedure.
- •The subject is willing and able to be contacted for minimum of 6 weeks follow up.
- •The subject or guardian must provide written informed consent using a form that is reviewed and approved by the Ethics Committee.
排除标准
- •The subject has a known hypersensitivity or contraindication to heparin, bovine or seafood products.
- •The subject has a history of bleeding diathesis or coagulopathy, or will refuse blood transfusion.
- •The subject is currently enrolled in this, or another investigational device or drug trail that has not completed the required follow-up period.
- •ArterX Vascular Sealant should not be used in patients who have exhibited an allergic reaction to materials of shellfish or bovine origin.
结局指标
主要结局
Number of anastomoses with immediate sealing of the suture line
时间窗: Intraoperative
Immediate suture line sealing on clamp removal, as evidenced by a lack of clinically significant bleeding. A minimum of 50% of the anastomoses were expected to be sealed immediately.
次要结局
未报告次要终点
研究者
研究点 (3)
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