临床试验

ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement

NCT：NCT03735667 · ACTIVE_NOT_RECRUITING

NCT编号NCT03735667

状态ACTIVE_NOT_RECRUITING

开始日期2019-06-10

SponsorBoston Scientific Corporation (INDUSTRY)

First posted2018-11-08

Last updated2026-09-16

简要摘要

To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR. As of 28-May-2025, Boston Scientific Corporation (BSC) announced the voluntary global discontinuation of the ACURATE product platform, including both the ACURATE neo2 and ACURATE Prime Aortic Valve Systems. BSC will no longer pursue regulatory approval for the device in the U.S. or other unapproved geographies.

官方来源

在 ClinicalTrials.gov 上查看 →

数据来自 ClinicalTrials.gov API。有关最新状态，请参阅官方记录。