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En studie av Choydar Flow-Directed Mesh Stent vid behandling av orupturerade intrakraniella aneurismer (CROWN)

2 november 2026 uppdaterad av: Johnson & Johnson Medical (Shanghai) Ltd.

En multicenter, prospektiv, enarms observationsstudie för att utvärdera säkerheten och effektiviteten hos Choydar Flow-Directed Mesh Stent vid behandling av orupturerade intrakraniella aneurysm

The purpose of this study is to assess how safe choydar flow-directed mesh stent is and how well it works in the treatment of unruptured intracranial aneurysms (a condition in which a bulging blood vessel in the brain can burst and cause bleeding) in a real-world setting.

Studieöversikt

Status

Rekrytering

Betingelser

Studietyp

Observationell

Inskrivning (Beräknad)

200

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kina
      • Chenzhou, Kina, 432000
        • Rekrytering
        • Chenzhou No.1 People's Hospital
      • Guangzhou, Kina, 519041
        • Rekrytering
        • Guangdong Provincial People's Hospital
      • Nanjing, Kina, 210008
        • Rekrytering
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
      • Nanjing, Kina, 210029
        • Rekrytering
        • The First Affiliated Hospital of Nanjing Medical University
      • Nanyang, Kina, 473000
        • Rekrytering
        • Nanyang Central Hospital
      • Taiyuan, Kina, 30012
        • Rekrytering
        • Shanxi Provincial People's Hospital
      • Wuhu, Kina, 241001
        • Rekrytering
        • The First Affiliated Hospital of Wannan Medical College
      • Zhengzhou, Kina, 450052
        • Rekrytering
        • The First Affiliated Hospital of Zhengzhou University

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

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Adult participants with unruptured wide-neck (neck width >= 4 mm or dome-to-neck ratio <2) saccular or fusiform aneurysms in the internal carotid artery (from the petrous segment to the distal end) and the vertebral artery arising from a parent vessel with a diameter >= 2.0 mm and <= 6.0 mm.

Beskrivning

Inclusion criteria:

Participants meeting all the following inclusion criteria will be included:

Preoperative inclusion criteria:

  • Presence of unruptured aneurysms in the internal carotid artery (from the petrous segment to the distal end) or vertebral artery identified by digital subtraction angiography (DSA), computed tomography angiography (CTA), or magnetic resonance angiography (MRA) prior to surgery, wide-neck (neck width greater than or equal to [>=] 4 millimeters [mm] or dome-to-neck ratio less than [<] 2) saccular or fusiform aneurysms, and the parent artery diameter must be >= 2.0 mm and less than or equal to [<=] 6.0 mm
  • Participants and/or their authorized representatives understand the purpose of the study, and are willing to voluntarily participate in the study and sign the informed consent form (ICF)
  • Prior to enrollment, a clinical decision has already been made to use the choydar flow-directed mesh stent
  • Participants who are willing and able to return for all follow-up visits as required by the study protocol

Intraoperative inclusion criteria:

- Presence of unruptured aneurysms in the internal carotid artery (from the petrous segment to the distal end) or vertebral artery identified by DSA during the procedure, wide-neck (neck width >= 4 mm or dome-to-neck ratio <2) saccular or fusiform aneurysms, and the parent artery diameter must be >= 2.0 mm and <= 6.0 mm

Exclusion criteria:

Participants meeting any of the following exclusion criteria will be excluded:

  • Participants with anatomy are unsuitable for flow diverter passage or placement or lesions unsuitable for flow diverter delivery and deployment (for example, the lesion vessel is excessively tortuous or tiny, the flow diverter cannot reach the lesion site, stenosis exists in the target vessel of recurrent aneurysm, or the flow diverter is not completely deployed)
  • Participants who are allergic to contrast media
  • Participants who are allergic to nickel-titanium alloy or platinum-tungsten alloy
  • Participants who are contraindicated for antiplatelet and/or anticoagulant therapy
  • Participants with active bacterial infections
  • Participants who are confirmed positive pregnancy (for example, via test or oral communication) according to the site-specific standard of care
  • Participants who are currently participating in an investigational (drug, device, etc.) clinical study that may confound the study endpoints (excluding observational, natural history, and/or epidemiological studies that do not require interventions)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiv: PROSPECTIVE

Kohorter och interventioner

Grupp / Kohort
Choydar Flow-Directed Mesh Stent

The choydar flow-directed mesh stent will be used in accordance to its Instructions For Use (IFU) in participants with unruptured intracranial aneurysms. Participants will not receive any other intervention as a part of this study.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Complete Aneurysm Occlusion Rate at 12 Months Post-Procedure (Raymond-Roy Class I)
Tidsram: At 12 months follow-up post-procedure

Complete aneurysm occlusion rate as per Raymond Roy classification criteria (Class I) is defined as complete obliteration (no contrast filling in aneurysm body or neck). It is calculated as follows: number of target aneurysms achieving Raymond-Roy Class I occlusion at 12-month follow-up post-procedure/number of target aneurysms with 12-month imaging evaluation * 100 percent (%).
At 12 months follow-up post-procedure
Adequate Aneurysm Occlusion Rate at 12-month Follow-up Post-Procedure (Raymond-Roy Classes I and II)
Tidsram: At 12 months follow-up post-procedure

Adequate aneurysm occlusion rate as per Raymond Roy classification criteria (Class II and III) is defined as Class II: residual neck (contrast filling in aneurysm neck but none in aneurysm body) and Class III: residual aneurysm (contrast filling in aneurysm body). It is calculated as follows: number of target aneurysms achieving Raymond-Roy Class I/II occlusion at 12-month follow-up post-procedure/number of target aneurysms with 12-month imaging evaluation * 100 %.
At 12 months follow-up post-procedure
Percentage of Participants with Immediate Technical Success Rate of Procedure
Tidsram: At Day 0 (Day of procedure)

Percentage of participants with immediate technical success rate of procedure will be reported. Immediate technical success of the procedure is defined as the percentage of participants in whom the flow diverter is successfully deployed during the procedure, with accurate positioning confirmed by intra-procedure angiography, and with effective coverage of the aneurysm neck by the implant. It is calculated as follows: number of participants with successful placement of the investigational device/total number of participants undergoing the treatment * 100 %.
At Day 0 (Day of procedure)
Re-treatment Rate of Target Aneurysm at 12-Month Follow-up Post-Procedure
Tidsram: At 12 months follow-up post-procedure

The incidence of re-treatment of the target aneurysm at 12 months follow-up post-procedure will be reported.
At 12 months follow-up post-procedure
Percentage of Participants with Modified Rankin Scale (mRS) Score of 0-2 at 12 Months Post-Procedure
Tidsram: At 12 months follow-up post-procedure

Percentage of participants with mRS score of 0-2 at 12 months post-procedure will be reported. The mRS score is issued to evaluate the improvement of neurological function. It assesses the ability of participants with neurological disease to live independently. There are 7 levels of this score, 0 points represent no symptoms of disability, higher scores mean worse prognosis of participants , and 6 points represent death.
At 12 months follow-up post-procedure
Number of Participants with Major Ischemic/Hemorrhagic Events and/or Death During Perioperative Period
Tidsram: Perioperative

Number of participants with major ischemic/hemorrhagic events and/or death during perioperative period will be reported. Major ischemic/hemorrhagic events are defined as an increase of >= 4 points in the National Institutes of Health Stroke Scale (NIHSS) score compared with the previous score.
Perioperative
Number of Participants with Major Ischemic/Hemorrhagic Events and/or Death During 12-Month Follow-up
Tidsram: At 12 months follow-up post-procedure

Number of participants with major ischemic/hemorrhagic events and/or death during 12 months follow-up period will be reported. Major ischemic/hemorrhagic events are defined as an increase of >= 4 points in the NIHSS score compared with the previous score.
At 12 months follow-up post-procedure
Number of Participants with Severe in-Stent Stenosis (Greater Than [>] 50%) During 12-Month Follow-up
Tidsram: At 12 months follow-up post-procedure

Number of participants with severe in-stent stenosis during 12-month follow-up period will be reported. The percent stenosis is calculated according to the calculation method of Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) study as follows: (1 - Ds [Diameter of the artery at the site of the most severe stenosis]/Dn [Diameter of the normal artery]) * 100%.
At 12 months follow-up post-procedure
Rupture Rate of Target Aneurysm During 12-Month Follow-Up Post-Procedure
Tidsram: At 12 months follow-up post-procedure

The incidence of rupture of the target aneurysm within 12 months post-procedure will be reported.
At 12 months follow-up post-procedure

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Johnson & Johnson Medical (Shanghai) Ltd.

Utredare

  • Studierektor: Johnson & Johnson Medical (Shanghai) Ltd. Clinical Trial, Johnson & Johnson Medical (Shanghai) Ltd.

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)

28 januari 2026

Primärt slutförande (Beräknad)

10 februari 2028

Avslutad studie (Beräknad)

10 februari 2028

Studieregistreringsdatum

Först inskickad

13 november 2025

Först inskickad som uppfyllde QC-kriterierna

13 november 2025

Första postat (Faktisk)

14 november 2025

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CNV202507

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

The data sharing policy of Johnson & Johnson MedTech is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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