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临床试验/NCT04392492
NCT04392492
Unknown
不适用

Plug-based Percutaneous Vascular Closure Device in Transcatheter Aortic Valve Replacement

Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人2017年1月25日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Aortic Valve Stenosis
发起方
Karolinska University Hospital
入组人数
1000
试验地点
1
主要终点
Number of patients with major vascular complications
最后更新
5年前

概览

简要总结

Evaluation of the safety and efficacy of a percutaneous plug-based large-bore vascular closure device for femoral artery closure in an unselected consecutive patient cohort undergoing transcatheter aortic valve implantation in a single-center prospective study.

注册库
clinicaltrials.gov
开始日期
2017年1月25日
结束日期
2021年1月31日
最后更新
5年前
研究类型
Observational
性别
All

研究者

发起方
Karolinska University Hospital
责任方
Principal Investigator
主要研究者

Magnus Dalén

Associate professor

Karolinska University Hospital

入排标准

入选标准

  • Patients undergoing transfemoral TAVI at the Karolinska University Hospital

排除标准

  • Patients undergoing TAVI with access other than transfemoral
  • Use of closure device other than MANTA

结局指标

主要结局

Number of patients with major vascular complications

时间窗: 6 week follow up

Major vascular access site complications according to the VARC-2 definitions

次要结局

  • Number of patients with minor vascular complications(6 week follow up)
  • Number of patients with vascular closure device failure(6 week follow up)
  • Number of patients with life-threatening, disabling or major bleeding(6 week follow up)

研究点 (1)

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