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En studie av Choydar Flow-Directed Mesh Stent i behandlingen av ikke-rupturerte intrakranielle aneurismer (CROWN)

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

En multicentrisk, prospektiv, ensidig observasjonsstudie for å evaluere sikkerheten og effektiviteten til Choydar Flow-Directed Mesh Stent i behandlingen av uopprevne intrakranielle aneurismer

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.

Studieoversikt

Status

Rekruttering

Forhold

Studietype

Observasjonsmessig

Registrering (Antatt)

200

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og intervensjoner

Gruppe / 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Complete Aneurysm Occlusion Rate at 12 Months Post-Procedure (Raymond-Roy Class I)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Johnson & Johnson Medical (Shanghai) Ltd.

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. januar 2026

Primær fullføring (Antatt)

10. februar 2028

Studiet fullført (Antatt)

10. februar 2028

Datoer for studieregistrering

Først innsendt

13. november 2025

Først innsendt som oppfylte QC-kriteriene

13. november 2025

Først lagt ut (Faktiske)

14. november 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CNV202507

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

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