Evaluation of the Safety and Effectiveness of CHORDS® Cerebral Protection System During TAVR: DUET Trial
12 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
240
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: XU
- Telefonnummer: 021-50206611
- E-post: j.xu@resonmed.com
Studieorter
-
-
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Shanghai, Kina
- Rekrytering
- Zhongshan hospital, Fudan university
-
Huvudutredare:
- Junbo Ge, MD
-
Kontakt:
- Yiju Gao
- Telefonnummer: 021-31587861
- E-post: lcsyjg@zs-hospital.sh.cn
-
Underutredare:
- Wenzhi Pan, MD
-
-
Anhui
-
Bengbu, Anhui, Kina
- Rekrytering
- the First Affiliated Hospital of Bengbu Medical College
-
Kontakt:
- Huan Zhou
- Telefonnummer: 0552-3086943
- E-post: byyfygcp@163.com
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Huvudutredare:
- Jinjun Liu
-
Hefei, Anhui, Kina
- Rekrytering
- Anhui Provincial Hospital
-
Huvudutredare:
- Fan Ouyang
-
Kontakt:
- Yu Tai
- Telefonnummer: 0551-62283760
- E-post: ahslyygcp@163.com
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-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina
- Rekrytering
- Beijing AnZhen Hospital, Capital Medical University
-
Kontakt:
- Zhang Yingchao
- Telefonnummer: 010-64456966
- E-post: office@anzhengcp.com
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Huvudutredare:
- Xinmin Liu
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-
Chongqing Municipality
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Chongqing, Chongqing Municipality, Kina
- Rekrytering
- The First Affiliated Hospital of the Army Medical University of the Chinese People's Liberation Army
-
Huvudutredare:
- Zhihui Zhang
-
Kontakt:
- Xie Linli
- Telefonnummer: 023-68766775
- E-post: cqxnyy@qq.com
-
-
Fujian
-
Fuzhou, Fujian, Kina
- Rekrytering
- Fujian Medical University Union Hospital
-
Kontakt:
- Cai Xinmei
- Telefonnummer: 0591-86218304
- E-post: xhyyjgb@163.com
-
Huvudutredare:
- Lianglong Chen
-
Fuzhou, Fujian, Kina
- Har inte rekryterat ännu
- The First Affiliated Hospital of Fujian Medical University
-
Kontakt:
- Wu Anpeng
- Telefonnummer: 87981029
- E-post: fjydfyjg@163.com
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Huvudutredare:
- Dajun Chai
-
-
Guangdong
-
Guangzhou, Guangdong, Kina
- Rekrytering
- Guangdong Provincial People's Hospital
-
Kontakt:
- Jiang Faye
- Telefonnummer: 020-83525815
- E-post: gdphgcp@gdph.org.cn
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Huvudutredare:
- Jianfang Luo
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Guangzhou, Guangdong, Kina
- Rekrytering
- The First Affiliated Hospital of Sun Yat-sen University
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Huvudutredare:
- Yi Li
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Kontakt:
- Tang Lei
- Telefonnummer: 020-87608185
- E-post: ctc1983@mail.sysu.edu.cn
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Guangzhou, Guangdong, Kina
- Rekrytering
- Southern medical university Nanfang hospital
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Huvudutredare:
- Jiancheng Xiu
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Kontakt:
- Su Aishan
- Telefonnummer: 020- 62786845
- E-post: nfyyyw@126.com
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Guangzhou, Guangdong, Kina
- Rekrytering
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
-
Kontakt:
- Zou Yanqin
- Telefonnummer: 020- 81332371
- E-post: ywjgbgs@163.com
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Huvudutredare:
- Yangxin Chen
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Huvudutredare:
- Haifeng Zhang
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Jiangxi
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Nanchang, Jiangxi, Kina
- Rekrytering
- The First Affiliated Hospital of Nanchang University
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Huvudutredare:
- Xiaoping Peng
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Kontakt:
- Wen Jinhua
- Telefonnummer: 0791-88695051
- E-post: ncuyfygcp2018@163.com
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-
Shandong
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Qingdao, Shandong, Kina
- Rekrytering
- Qingdao University Affiliated Hospital
-
Kontakt:
- Cao Yu
- Telefonnummer: 0532-82911767
- E-post: qingyilunli@126.com
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Huvudutredare:
- Zhexun Lian
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-
Sichuan
-
Chengdu, Sichuan, Kina
- Rekrytering
- West China Hospital, Sichuan University
-
Huvudutredare:
- Jun Shi
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Kontakt:
- Zhen Li
- Telefonnummer: 18980601950
- E-post: huaxigcp@163.com
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-
Zhejiang
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Wenzhou, Zhejiang, Kina
- Rekrytering
- The First Affiliated Hospital of Wenzhou Medical University
-
Huvudutredare:
- Hao Zhou
-
Kontakt:
- Huang Xiaoxiao
- Telefonnummer: 0577-55579591
- E-post: wyyy@wzhospital.cn
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: TAVR+CHORDS
Participants undergo TAVR with the 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
|
Undergo TAVR procedure with Sentinel Cerebral Protection System
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of freedom from Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Tidsram: 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)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The perentage of patient with device success
Tidsram: Acute post-procedure
|
Successful delivery, deployment both distal and proximal filters in appropriate anatomical locations, and retrieval of the device
|
Acute post-procedure
|
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The percentage of patient with procedural success
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Acute post-procedure
|
Histopathological analysis includes type, size and number
|
Acute post-procedure
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
31 oktober 2025
Primärt slutförande (Beräknad)
30 september 2026
Avslutad studie (Beräknad)
31 december 2026
Studieregistreringsdatum
Först inskickad
6 juni 2026
Först inskickad som uppfyllde QC-kriterierna
12 juni 2026
Första postat (Faktisk)
15 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CHORDS-2025
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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