Percutaneous Plug-based Femoral Arteriotomy Closure Device Use in Surgery for Acute Type A Aortic Disection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Femoral access site complication
研究概览
简要总结
A single-center prospective study. Patients undergoing surgery for acute type A aortic dissection with femoral arterial cannulation between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden are eligible. Femoral cannulation was performed either with surgical cut-down and arterial puncture under direct vision or percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania). Data regarding preoperative clinical characteristics and operative details were obtained by medical records review.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Operated for acute type A aortic dissection between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden.
排除标准
- •Non-femoral arterial cannulation
- •Concomitant femoro-femoral bypass
- •Conversion to ECMO with arterial inflow in the previously cannulated femoral artery
- •Death within 30 days from procedure
- •Loss to follow-up
结局指标
主要结局
Femoral access site complication
时间窗: During the first 8 weeks after surgery
Seroma, wound infection, or nerve injury
次要结局
- Femoral artery complication(During the first 3 years after surgery)
研究者
Magnus Dalén
MD, PhD
Karolinska University Hospital