Multi-center, Prospective, PM Registry for Procedural Outcomes Using the Cardiva VASCADE VCS for Closing the Femoral Arteriotomy After Percutaneous Endovascular Procedures Via Antegrade Access.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 5
- 主要终点
- Time to Hemostasis (TTH)
研究概览
简要总结
The objective of the registry is to collect procedural outcomes data when the Cardiva VASCADE Vascular Closure System (VCS) is used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7F introducer sheaths via an antegrade approach.
详细描述
Due to the growing adoption of antegrade femoral access and the use of VCDs to close these arteriotomies, it is important to collect performance and complication outcomes data related to this procedural variable. The aim of this registry is to consistently collect prospective data on procedural outcomes on antegrade access cases closed with the VASCADE VCS in a way that is consistent with the RESPECT Study design and the FDA-approved Instructions for Use (IFU).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Acceptable candidate for post-procedural manual compression
- •Able to ambulate at least 20 feet, with or without assistance
排除标准
- •Active systemic or cutaneous infection or inflammation
- •Ipsilateral femoral arteriotomy with any of the following conditions: a) access within < or = 10 days; b) any residual hematoma, significant bruising, or known associated vascular complications; or c) within < or = 90 days, use of an intra-vascular closure device (i.e., Angioseal)
- •Previous vascular grafts or surgery at the target vessel access site
- •Major amputation of ipsilateral lower extremity - previous history of, or planned within next 30 days prior to study exit
- •Extreme morbid obesity (BMI greater than 4 kg/m2) or underweight (BMI less than 20 kg/m2)
- •Femoral arterial diameter < 6 mm at access site
- •Antegrade arterial access site is a side stick and/or is not a single anterior wall femoral puncture
- •Length of tissue tract, the distance between the anterior arterial wall and skin, is < 2.5 cm.
结局指标
主要结局
Time to Hemostasis (TTH)
时间窗: Procedural, usually within 15 minutes of enrollment
Time to Hemostasis (TTH) is defined as elapsed time between VASCADE device removal and first observed and confirmed arterial hemostasis.
Major Access Site Closure-related Complications
时间窗: Through 30 days +/- 7 days
Patient incident rate of combined major access site closure-related complications through 30 days
次要结局
- Time to Ambulation (TTA)(Prior to discharge, usually within 24 hours)
- Time to Discharge (TTD)(Through hospital discharge, usually within 24 hours)
- Device Success(Procedural, usually within 15 minutes of enrollment)
- Procedure Success(Through 30 +/- 7 days)
- Minor Access Site Closure-related Complications(Through 30 +/- 7 days)