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Evaluation of the Safety and Effectiveness of CHORDS® Cerebral Protection System During TAVR: DUET Trial

2026年6月12日 更新者：Resonova (Shanghai) Medtech Limited

A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Safety and Effectiveness of the Resonova® CHORDS® Cerebral Protection System in Capturing and Removing Embolic Debris During Transcatheter Aortic Valve Replacement

This is a prospective, multi-center, randomized controlled study. The goal of the study is to assess the safety and effectiveness of the Resonova® CHORDS® Cerebral Protection System in capturing and removing embolic debris during Transcatheter Aortic Valve Replacement (TAVR). A total of 240 eligible participants will be enrolled and randomized in a 1:1 ratio to undergo TAVR either with the CHORDS® Cerebral Protection System (Test group) or the Sentinel System (Control group).All the participants will be followed up at 30 days and 90 days post-procedure.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

240

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
      • Shanghai、中国
        • 招聘中
        • Zhongshan hospital, Fudan university
        • 首席研究员：
          • Junbo Ge, MD
        • 接触：
        • 副研究员：
          • Wenzhi Pan, MD
    • Anhui
      • Bengbu、Anhui、中国
        • 招聘中
        • the First Affiliated Hospital of Bengbu Medical College
        • 接触：
        • 首席研究员：
          • Jinjun Liu
      • Hefei、Anhui、中国
        • 招聘中
        • Anhui Provincial Hospital
        • 首席研究员：
          • Fan Ouyang
        • 接触：
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国
        • 招聘中
        • Beijing AnZhen Hospital, Capital Medical University
        • 接触：
        • 首席研究员：
          • Xinmin Liu
    • Chongqing Municipality
      • Chongqing、Chongqing Municipality、中国
        • 招聘中
        • The First Affiliated Hospital of the Army Medical University of the Chinese People's Liberation Army
        • 首席研究员：
          • Zhihui Zhang
        • 接触：
    • Fujian
      • Fuzhou、Fujian、中国
        • 招聘中
        • Fujian Medical University Union Hospital
        • 接触：
        • 首席研究员：
          • Lianglong Chen
      • Fuzhou、Fujian、中国
        • 尚未招聘
        • The First Affiliated Hospital of Fujian Medical University
        • 接触：
        • 首席研究员：
          • Dajun Chai
    • Guangdong
      • Guangzhou、Guangdong、中国
        • 招聘中
        • Guangdong Provincial People's Hospital
        • 接触：
        • 首席研究员：
          • Jianfang Luo
      • Guangzhou、Guangdong、中国
        • 招聘中
        • The First Affiliated Hospital of Sun Yat-sen University
        • 首席研究员：
          • Yi Li
        • 接触：
      • Guangzhou、Guangdong、中国
        • 招聘中
        • Southern medical university Nanfang hospital
        • 首席研究员：
          • Jiancheng Xiu
        • 接触：
      • Guangzhou、Guangdong、中国
        • 招聘中
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
        • 接触：
        • 首席研究员：
          • Yangxin Chen
        • 首席研究员：
          • Haifeng Zhang
    • Jiangxi
      • Nanchang、Jiangxi、中国
        • 招聘中
        • The First Affiliated Hospital of Nanchang University
        • 首席研究员：
          • Xiaoping Peng
        • 接触：
    • Shandong
      • Qingdao、Shandong、中国
        • 招聘中
        • Qingdao University Affiliated Hospital
        • 接触：
        • 首席研究员：
          • Zhexun Lian
    • Sichuan
      • Chengdu、Sichuan、中国
        • 招聘中
        • West China Hospital, Sichuan University
        • 首席研究员：
          • Jun Shi
        • 接触：
    • Zhejiang
      • Wenzhou、Zhejiang、中国
        • 招聘中
        • The First Affiliated Hospital of Wenzhou Medical University
        • 首席研究员：
          • Hao Zhou
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Male or non-pregnant female, ≥18 years
  • Patients with symptomatic severe aortic stenosis who are scheduled to undergo TAVR with commercialized transcatheter aortic valve system.
  • Compatible left common carotid artery (6.5-10 mm) and brachiocephalic artery (9-15mm) diameters without significant stenosis (> 70%)
  • Patients who are able to understand the study objectives, voluntarily participate, sign the informed consent form, and are willing to undergo required examinations and clinical follow-up.

Exclusion Criteria:

General

  • Contraindications to MRI, or planned implantation of an MRI-incompatible device at the index procedure, or planned implantation of an MRI-incompatible pacemaker or defibrillator within 30 days post-procedure.
  • Acute myocardial infarction ≤ 30 days before the intended treatment
  • Pure aortic regurgitation
  • Pre-existing prosthetic aortic valve
  • Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation
  • Contraindication to antiplatelet and/or anticoagulant therapy, nitinol , or contrast media, or refusal to receive blood transfusions
  • Vulnerable populations, including those unable to adequately understand the trial, those potentially subject to undue influence or coercion, those unable to complete the informed consent process, and those with severe disabling dementia or cognitive impairment Anatomic
  • Vasculature (ie, right radial/brachial artery, carotid artery) precluding the device access
  • Patients whose brachiocephalic or left carotid artery reveals significant stenosis（>70%）, ectasia, dissection, or aneurysm at the ostium or within 3 cm of the ostium

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：TAVR+CHORDS
Participants undergo TAVR with the CHORDS® Cerebral Protection System
设备：CHORDS® Cerebral Protection System
Undergo TAVR procedure with the CHORDS® Cerebral Protection System
有源比较器：TAVR+Sentinel
Participants undergo TAVR with the Sentinel Cerebral Protection System
设备：Sentinel Cerebral Protection System
Undergo TAVR procedure with Sentinel Cerebral Protection System

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incidence of freedom from Major Adverse Cardiac and Cerebrovascular Events (MACCE)
大体时间：30 days post-procedure
MACCE: all-cause death, disabling and non-disabling stroke, and Acute Kidney Injury (AKI) Stage 3 or higher at discharge or within7 days post-procedure, whichever occurs first (definitions of all-cause death, stroke, and AKI are based on VARC-3 criteria)
30 days post-procedure
Total new lesion volume (TLV, mm³) in protected territories(DW-MRI)
大体时间：2-7 days post-procedure
TLV will be assessed by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI). Protected territories are defined as the brain territories uniquely perfused by the vessels protected by the study device, namely the left and right carotid arteries, and right vertebral artery
2-7 days post-procedure

次要结果测量

结果测量
措施说明
大体时间
The perentage of patient with device success
大体时间：Acute post-procedure
Successful delivery, deployment both distal and proximal filters in appropriate anatomical locations, and retrieval of the device
Acute post-procedure
The percentage of patient with procedural success
大体时间：Acute post-procedure
Successful deployment of at least one filter during the TAVR procedure, without the occurrence of an device-related MACCE
Acute post-procedure
Total new lesion volume in the the protected territories and all territories(DW-MRI)
大体时间：2-7 days post-procedure
Assessed by DW-MRI.Protected territories are defined as the brain territories uniquely perfused by the vessels protected by the study device, namely the left and right carotid arteries, and right vertebral artery.
2-7 days post-procedure
Total new lesion volume in the protected territories and all territories(FLAIR-MRI)
大体时间：30 days post-procedure
Assessed by FLAIR-MRI.Protected territories are defined as the brain territories uniquely perfused by the vessels protected by the study device, namely the left and right carotid arteries, and right vertebral artery.
30 days post-procedure
Change in mRS from baseline
大体时间：Discharge (up to 7 days post-procedure), 30 days post-procedure
Assessed by modified Rankin score
Discharge (up to 7 days post-procedure), 30 days post-procedure
Change in NIHSS from baseline
大体时间：Discharge (up to 7 days post-procedure), 30 days post-procedure
Assessed by NIH Stroke Scale
Discharge (up to 7 days post-procedure), 30 days post-procedure
Incidence of MACCE
大体时间：Discharge (up to 7 days post-procedure), 30 days, and 90 days post-procedure
MACCE includes:all-cause mortality, disabling and non-disabling stroke, Acute kidney injury(Stage 3 or higher). Definitions follow VARC-3
Discharge (up to 7 days post-procedure), 30 days, and 90 days post-procedure
Incidence of major vascular complications
大体时间：Discharge (up to 7 days post-procedure), 30 days, and 90 days post-procedure
Definitions follow VARC-3
Discharge (up to 7 days post-procedure), 30 days, and 90 days post-procedure
Histopathological analysis of captured thrombus/debris
大体时间：Acute post-procedure
Histopathological analysis includes type, size and number
Acute post-procedure

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Resonova (Shanghai) Medtech Limited

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年10月31日

初级完成 (估计的)

2026年9月30日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2026年6月6日

首先提交符合 QC 标准的

2026年6月12日

首次发布 (实际的)

2026年6月15日

研究记录更新

最后更新发布 (实际的)

2026年6月15日

上次提交的符合 QC 标准的更新

2026年6月12日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CHORDS-2025

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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