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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство CHORDS® Cerebral Protection System
  Undergo TAVR procedure with the CHORDS® Cerebral Protection System
• Устройство Sentinel Cerebral Protection System
  Undergo TAVR procedure with Sentinel Cerebral Protection System

Первичные конечные точки

• Incidence of freedom from Major Adverse Cardiac and Cerebrovascular Events (MACCE) [Срок оценки: 30 days post-procedure]
• Total new lesion volume (TLV, mm³) in protected territories(DW-MRI) [Срок оценки: 2-7 days post-procedure]

Вторичные конечные точки (9)

• The perentage of patient with device success [Срок оценки: Acute post-procedure]
• The percentage of patient with procedural success [Срок оценки: Acute post-procedure]
• Total new lesion volume in the the protected territories and all territories(DW-MRI) [Срок оценки: 2-7 days post-procedure]
• Total new lesion volume in the protected territories and all territories(FLAIR-MRI) [Срок оценки: 30 days post-procedure]
• Change in mRS from baseline [Срок оценки: Discharge (up to 7 days post-procedure), 30 days post-procedure]
• Change in NIHSS from baseline [Срок оценки: Discharge (up to 7 days post-procedure), 30 days post-procedure]
• Incidence of MACCE [Срок оценки: Discharge (up to 7 days post-procedure), 30 days, and 90 days post-procedure]
• Incidence of major vascular complications [Срок оценки: Discharge (up to 7 days post-procedure), 30 days, and 90 days post-procedure]
• Histopathological analysis of captured thrombus/debris [Срок оценки: Acute post-procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 15 центров

• The First Affiliated Hospital of Bengbu Medical College — Bengbu
• Anhui Provincial Hospital — Хэфэй
• Beijing Anzhen Hospital, Capital Medical University — Пекин
• The First Affiliated Hospital of the Army Medical University of the Chinese People's Liber — Чунцин
• Fujian Medical University Union Hospital — Фучжоу
• The First Affiliated Hospital of Fujian Medical University — Фучжоу
• Guangdong Provincial People's Hospital — Гуанчжоу
• Southern Medical University Nanfang Hospital — Гуанчжоу
• … и ещё 7 центров

Идентификаторы

NCT: NCT07648693 · CHORDS-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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