Prospective, Multicenter, Non-controlled Study, Evaluating Safety and Performance of SETALUM™ Sealant as an add-on to Suture in Vascular Reconstruction in Patients Undergoing Carotid Enlargement Procedure Using an ePTFE Patch.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 主要终点
- Elapsed time from clamp release to hemostasis at the suture line
研究概览
简要总结
This is a prospective, multicenter, single-arm trial to evaluate the safety and performance of SETALUM™ Sealant in sealing suture lines at the anastomosis between native vessels and synthetic ePTFE vascular patch used during open vascular surgery.
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
- •≥18 years old;
- •Surgical placement of an ePTFE patch for large carotid repair;
- •Written informed consent given by the patient.
排除标准
- •Known or suspected allergy or sensitivity to any test materials or reagents;
- •Concomitant intake of immunosuppressive medications;
- •Prior radiation therapy to the operating field;
- •Previous surgical procedure performed on the same operating field;
- •Current or recent (<3months) participation in another investigational study;
- •Refusal to receive blood products;
- •Pregnant or breast-feeding women
研究组 & 干预措施
SETALUM™ Sealant
SETALUM™ Sealant to be applied on the suture line
干预措施: SETALUM™ Sealant (Device)
结局指标
主要结局
Elapsed time from clamp release to hemostasis at the suture line
时间窗: During surgical procedure
The hemostasis is observed by the operating surgeon and timed by an operative room nurse. Anastomotic hemostasis is defined as an anastomosis not requiring any additional intervention to control bleeding.
All adverse events occurring from the surgical procedure to Week 12
时间窗: Week 12
Each Adverse Event was described by the seriouness and the nature of its relationship to the SETALUM™ Sealant or to the surgical procedure. The Data Monitoring Committee reviewed all occurred adverse events and provided a conclusion on the SETALUM™ Sealant safety profile.
次要结局
未报告次要终点