Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

12. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

240

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
      • Shanghai, Kina
        • Rekruttering
        • Zhongshan Hospital, Fudan University
        • Ledende efterforsker:
          • Junbo Ge, MD
        • Kontakt:
        • Underforsker:
          • Wenzhi Pan, MD
    • Anhui
      • Bengbu, Anhui, Kina
        • Rekruttering
        • The First Affiliated Hospital of Bengbu Medical College
        • Kontakt:
        • Ledende efterforsker:
          • Jinjun Liu
      • Hefei, Anhui, Kina
        • Rekruttering
        • Anhui Provincial Hospital
        • Ledende efterforsker:
          • Fan Ouyang
        • Kontakt:
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina
        • Rekruttering
        • Beijing Anzhen Hospital, Capital Medical University
        • Kontakt:
        • Ledende efterforsker:
          • Xinmin Liu
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kina
        • Rekruttering
        • The First Affiliated Hospital of the Army Medical University of the Chinese People's Liberation Army
        • Ledende efterforsker:
          • Zhihui Zhang
        • Kontakt:
    • Fujian
      • Fuzhou, Fujian, Kina
        • Rekruttering
        • Fujian Medical University Union Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Lianglong Chen
      • Fuzhou, Fujian, Kina
        • Ikke rekrutterer endnu
        • The First Affiliated Hospital Of Fujian Medical University
        • Kontakt:
        • Ledende efterforsker:
          • Dajun Chai
    • Guangdong
      • Guangzhou, Guangdong, Kina
        • Rekruttering
        • Guangdong Provincial People's Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Jianfang Luo
      • Guangzhou, Guangdong, Kina
        • Rekruttering
        • The First Affiliated Hospital of Sun Yat-sen University
        • Ledende efterforsker:
          • Yi Li
        • Kontakt:
      • Guangzhou, Guangdong, Kina
        • Rekruttering
        • Southern Medical University Nanfang Hospital
        • Ledende efterforsker:
          • Jiancheng Xiu
        • Kontakt:
      • Guangzhou, Guangdong, Kina
        • Rekruttering
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
        • Kontakt:
        • Ledende efterforsker:
          • Yangxin Chen
        • Ledende efterforsker:
          • Haifeng Zhang
    • Jiangxi
      • Nanchang, Jiangxi, Kina
        • Rekruttering
        • The First Affiliated Hospital of Nanchang University
        • Ledende efterforsker:
          • Xiaoping Peng
        • Kontakt:
    • Shandong
      • Qingdao, Shandong, Kina
        • Rekruttering
        • Qingdao University Affiliated Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Zhexun Lian
    • Sichuan
      • Chengdu, Sichuan, Kina
        • Rekruttering
        • West China Hospital, Sichuan University
        • Ledende efterforsker:
          • Jun Shi
        • Kontakt:
    • Zhejiang
      • Wenzhou, Zhejiang, Kina
        • Rekruttering
        • The First Affiliated Hospital of Wenzhou Medical University
        • Ledende efterforsker:
          • Hao Zhou
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: TAVR+CHORDS
Participants undergo TAVR with the CHORDS® Cerebral Protection System
Enhed: CHORDS® Cerebral Protection System
Undergo TAVR procedure with the CHORDS® Cerebral Protection System
Aktiv komparator: TAVR+Sentinel
Participants undergo TAVR with the Sentinel Cerebral Protection System
Enhed: Sentinel Cerebral Protection System
Undergo TAVR procedure with Sentinel Cerebral Protection System

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of freedom from Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The perentage of patient with device success
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Acute post-procedure
Histopathological analysis includes type, size and number
Acute post-procedure

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Resonova (Shanghai) Medtech Limited

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

31. oktober 2025

Primær færdiggørelse (Anslået)

30. september 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

6. juni 2026

Først indsendt, der opfyldte QC-kriterier

12. juni 2026

Først opslået (Faktiske)

15. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CHORDS-2025

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Cerebral vaskulær ulykke (CVA)/slagtilfælde

Kliniske forsøg med CHORDS® Cerebral Protection System

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Macedonia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner