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临床试验/NCT05936996
NCT05936996已完成不适用

Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes

Essential Medical, Inc.10 个研究点 分布在 2 个国家目标入组 258 人开始时间: 2023年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
258
试验地点
10
主要终点
Time to Hemostasis

研究概览

简要总结

This is an observational study designed to evaluate the safety and clinical outcomes of the MANTA® Vascular Closure Device (VCD) (the MANTA® Device) in TAVR procedures. The study will enroll participants who are undergoing a TAVR procedure. The purpose of this study is to examine and collect data on outcomes of contemporary MANTA® large bore closure in standard of care (SOC) TAVR procedures with on-label use of the MANTA® device including appropriate patient selection and proper vascular access.

详细描述

In the U.S. and Canada, the MANTA® Vascular Closure Device is indicated for closure of femoral arterial access sites while reducing time to hemostasis following the use of 10-20F devices or sheaths (12-25F OD) in endovascular catheterization procedures. In Israel, the 14F MANTA® is indicated for closure of femoral arterial access sites following the use of 10-14F devices or sheaths (maximum OD/profile of 18F), and the 18F MANTA® device is indicated for closure of femoral arterial access sites following the use of 15-18F devices or sheaths (maximum OD/profile of 25F). The purpose of the study is to examine and collect data on outcomes of contemporary MANTA® large bore closure in standard of care (SOC) TAVR procedures with on-label use of the MANTA® device including appropriate patient selection and proper vascular access.

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
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Candidate meets criteria for on-label use of MANTA® VCD as specified in the country-specific MANTA® VCD Instructions for Use (IFU), per judgement of the investigator.
  • Age ≥21 years

排除标准

  • Unable or unwilling to give informed consent or unwilling to complete follow-up assessments.

结局指标

主要结局

Time to Hemostasis

时间窗: During the procedure

The elapsed time between MANTA® deployment and first observed and confirmed arterial hemostasis

Rate of VARC-3 Major & Minor Vascular complications

时间窗: within 30 days of TAVR procedure

次要结局

  • Ambulation Success:(During procedure admission)
  • Treatment Success:(within 30 days of TAVR procedure)
  • Technical Success:(During the procedure)
  • Additional interventions: Required at large bore access site to address complications(within 30 days following the procedure)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (10)

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