A Comparison Study of the Perclose Proglide (TM) SMC System Versus Figure-of-8- Suture Technique for Closure of Large-bore Femoral Venous Access. (PERCLOSE-PROGLIDE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Assessment of rebleeding
研究概览
简要总结
This study aims to compare the efficacy and safety of two strategies for closing large caliber venous access in patients undergoing percutaneous procedures: compression with figure-of-8 suture versus closure with the Perclose-Proglide system.
详细描述
This is a retrospective observational study that aims to compare two strategies for closing large-caliber femoral venous access in patients who have undergone percutaneous procedures.
The study's goal is to determine if there are significant differences in terms of efficacy and safety between the two closure strategies. Figure-of-8 suture compression is a well-established technique that has been used for decades to close large-bore femoral venous access, while the Perclose-Proglide system is a relatively new medical device that could have great utility for the closure of large-bore femoral venous access. By comparing these two strategies, researchers hope to determine the safety and effectiveness of the Perclose-Proglide system for closing large-bore femoral venous access in patients undergoing percutaneous procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Patients will meet all inclusion criteria:
- •Adult patients aged > 18 years
- •Patients who have undergone percutaneous interventional procedures
- •Patients in whom the procedures have been performed with femoral venous access
- •Patients who have required large caliber pods ≥ 14 French.
排除标准
- •Patients must not meet any exclusion criteria:
- •Patients who have required access with surgical exposure.
- •Patients who have required ipsilateral arterial access with a large caliber ≥ 14 French
- •Patients with previous vascular surgery.
结局指标
主要结局
Assessment of rebleeding
时间窗: Discharge (assessed up to day 5)
Incidence of patients with rebleeding
Rebleeding
时间窗: 30 days
Incidence of patients with rebleeding
Assessment of Major vascular complications
时间窗: Discharge (assessed up to day 5)
Incidence of patients with Major vascular complications
次要结局
- Assessment of Hematoma(24 hours)
- Assessment of Hematoma Size(24 hours)
- Assessment of sitting-walking time(Discharge (assessed up to day 5))
- Assessment of Technical success(1 minute after closure performed)
- Assessment of Urinary infections(Discharge (assessed up to day 5))
- Assessment of Clinical success(Discharge (assessed up to day 5))
- Assessment of Death(30 days)
- Assessment of Death related to vascular access(Discharge (assessed up to day 5))
- Assessment of Vascular access point infection(30 days)