A Single Center, Retrospective Study Evaluating the Use of the SoloPath® Sheath in Reducing Vascular and Bleeding Complications After Transcatheter Aortic Valve Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Vascular Access Site Complications
研究概览
简要总结
This study is a retrospective, single center data collection to assess bleeding and vascular complications associated with TAVI when a SoloPath® Balloon Expandable TransFemoral Introducer is used for vascular access.
详细描述
This study is intended to collect data on the rate of vascular complications in subjects having transfemoral TAVI when the SoloPath® Balloon Expandable TransFemoral Introducer is used as a guide for introduction and delivery of TAVI devices. The use of a small profile sheath could possibly reduce the incidence of post procedure vascular complications associated with TAVI and further enhance the safety of accessing the femoral delivery route.
In addition, this study will examine the impact of arterial morphology and other subject risk factors as a predictor of clinical outcomes within 30 days following TAVI.
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
- •Subject must have undergone a TAVI procedure with femoral access achieved with a 19Fr (ID) SoloPath (STFI) sheath.
- •Male or female ≥ 18 years old.
排除标准
- •Subjects with Femoral or Iliac vessels less than 6mm on side of TAVI access will be excluded.
- •Subjects treated before January 1, 2011, are excluded from this analysis.
结局指标
主要结局
Vascular Access Site Complications
时间窗: withn 30 days of TAVI procedure
Rate of VARC-2 defined vascular complications within 30 days of TAVI.
次要结局
- Bleeding Complications at the Access Site(within 30 days of TAVI procedure)