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Early Complications After Flow Diverter Versus Stent-Assisted Coiling for Unruptured Wide-Neck Intracranial Bifurcation Aneurysms (FD-SAC BAS)

4. august 2026 oppdatert av: Feng wen feng, Nanfang Hospital, Southern Medical University

Early Complications After Flow Diverter Versus Stent-Assisted Coiling for Unruptured Wide-Neck Intracranial Bifurcation Aneurysms: A Prospective Real-World Cohort Study

This prospective real-world cohort study aims to compare early postoperative complications between flow diverter treatment and stent-assisted coiling in patients with unruptured wide-neck intracranial bifurcation aneurysms. A total of 274 patients from three centers in China will be enrolled and assigned to the flow diverter group or the stent-assisted coiling group according to the treatment received in routine clinical practice. The primary outcome is a composite of any stroke or all-cause death within 30 days after the procedure. The study will also collect demographic, clinical, laboratory, imaging, aneurysm morphological, procedural, and follow-up data to evaluate the safety of these two endovascular treatment strategies in a real-world setting.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Intracranial bifurcation aneurysms are common and are challenging to treat because of their complex anatomy. Flow diverters have emerged as an innovative endovascular therapy and have shown preliminary efficacy in bifurcation aneurysms. However, compared with conventional stent-assisted coiling, real-world evidence regarding early postoperative complication risks and related influencing factors remains limited.

This study will establish a prospective multicenter real-world database to compare the incidence of early complications after treatment with a flow diverter versus stent-assisted coiling in patients with unruptured wide-neck intracranial bifurcation aneurysms. Eligible patients who provide informed consent and meet the inclusion and exclusion criteria will be enrolled from three centers in China. Patients treated with a flow diverter will enter the flow diverter group, and patients treated with stent-assisted coiling will enter the stent-assisted coiling group.

All patients will undergo preoperative evaluation, perioperative management, postoperative antiplatelet therapy, and follow-up according to clinical practice and relevant guidelines. Data collected will include demographic characteristics, medical history, physical examination, laboratory tests, imaging findings, aneurysm morphology, procedural details, device information, medication history, and adverse events. Follow-up will be performed at 30 days after treatment to assess safety outcomes.

Studietype

Observasjonsmessig

Registrering (Antatt)

274

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

  • Kina
      • Guangzhou, Kina
        • Rekruttering
        • Zhujiang Hospital, Southern Medical University
        • Ta kontakt med:
      • Guangzhou, Kina
        • Rekruttering
        • Guangdong Province People's Hospital
        • Ta kontakt med:
    • Guangdong
      • Guangzhou, Guangdong, Kina
        • Rekruttering
        • Nanfang Hospital, Southern Medical University
        • Ta kontakt med:
          • Wenfeng Feng Feng, Principal Investigator, MD
          • Telefonnummer: 13501509911
          • E-post: fengwf1967@163.com

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients aged 18 to 75 years with unruptured, saccular, wide-neck intracranial bifurcation aneurysms diagnosed by CTA, MRA, or DSA who meet the clinical indications for endovascular treatment and are treated at participating centers. Eligible patients must provide written informed consent and will receive either flow diverter treatment or stent-assisted coiling according to the study protocol.

Beskrivelse

Inclusion Criteria:

  • Voluntarily provides written informed consent.
  • Aged 18 to 75 years.
  • Diagnosed by CTA, MRA, or DSA as having an unruptured, bifurcation, saccular, wide-neck intracranial aneurysm.
  • Able to understand the purpose of the study.

Exclusion Criteria:

  • Patients with two or more multiple aneurysms, all of which require treatment within 1 year.
  • Patients with other cerebrovascular diseases such as arteriovenous malformation or moyamoya disease.
  • Patients with ruptured aneurysms or narrow-neck aneurysms.
  • Patients who experienced stroke, including cerebral hemorrhage or cerebral infarction, within the past 1 month.
  • Patients with poor clinical condition, defined as modified Rankin Scale score ≥3.
  • Patients who have already planned to undergo surgical or interventional treatment within 3 months.
  • Patients considered by the investigator to be unsuitable for endovascular treatment, such as those with no suitable vascular access, excessively tortuous vessels, or difficulty in stent delivery.
  • Patients unsuitable for anesthesia or endovascular treatment, including those with major heart, lung, liver, spleen, or kidney disease, brain tumor, severe active infection, disseminated intravascular coagulation, or a history of severe psychiatric disorder.
  • Patients unable to receive antiplatelet or anticoagulant therapy.
  • Patients with a previous or possible severe reaction to contrast agents that would prevent completion of pre-treatment medication or treatment.
  • Patients with a known history of allergy to cobalt-chromium or nickel-titanium alloy materials.
  • Patients who participated in another drug or medical device clinical trial before enrollment and have not reached the time point of the primary endpoint.
  • Pregnant or lactating women.
  • Patients with life expectancy less than 12 months.
  • Patients judged by the investigator to have poor compliance and inability to complete the study as required

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Flow Diverter Group
Patients with unruptured wide-neck intracranial bifurcation aneurysms who receive flow diverter treatment in routine clinical practice.
Enhet: Flow Diverter
Flow diverter treatment will be performed according to routine clinical practice and relevant guidelines. A flow-diverting stent will be deployed to cover the aneurysm neck after angiographic evaluation and device sizing. Perioperative management and antiplatelet therapy will be performed according to the study protocol and clinical practice.
Stent-Assisted Coiling Group
Patients with unruptured wide-neck intracranial bifurcation aneurysms who receive stent-assisted coiling in routine clinical practice.
Enhet: Stent-Assisted Coiling
Stent-assisted coiling will be performed according to routine clinical practice and relevant guidelines. A stent will be deployed across the aneurysm neck, followed by coil embolization of the aneurysm. Perioperative management and antiplatelet therapy will be performed according to the study protocol and clinical practice.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Composite incidence of any stroke or all-cause death within 30 days after procedure
Tidsramme: Within 30 days after procedure
The primary outcome is the occurrence of any stroke or all-cause death within 30 days after the endovascular procedure. Stroke is defined as an acute onset of focal or global neurological dysfunction caused by vascular injury of the brain, spinal cord, or retina due to hemorrhage or infarction, with symptoms lasting 24 hours or longer.
Within 30 days after procedure

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of any stroke within 30 days after procedure
Tidsramme: Within 30 days after procedure
Incidence of any ischemic or hemorrhagic stroke within 30 days after the procedure.
Within 30 days after procedure
Incidence of transient ischemic attack within 30 days after procedure
Tidsramme: Within 30 days after procedure
Incidence of transient ischemic attack within 30 days after the procedure. Transient ischemic attack is defined as a transient episode of focal neurological dysfunction caused by ischemia of the brain, spinal cord, or retina, with symptoms lasting less than 24 hours and without acute infarction.
Within 30 days after procedure
Incidence of all-cause death within 30 days after procedure
Tidsramme: Within 30 days after procedure
Incidence of death from any cause within 30 days after the procedure.
Within 30 days after procedure
Incidence of adverse events and serious adverse events within 30 days after procedure
Tidsramme: Within 30 days after procedure
Incidence of adverse events and serious adverse events recorded during the perioperative period and follow-up period.
Within 30 days after procedure

Samarbeidspartnere og etterforskere

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

Sponsor

Nanfang Hospital, Southern Medical University

Samarbeidspartnere

Zhujiang Hospital
Guangdong Province People's Hospital

Etterforskere

  • Hovedetterforsker: Wenfeng Feng, MD, Nanfang Hospital, Southern Medical University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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)

19. mars 2026

Primær fullføring (Antatt)

19. mars 2027

Studiet fullført (Antatt)

19. mars 2028

Datoer for studieregistrering

Først innsendt

4. august 2026

Først innsendt som oppfylte QC-kriteriene

4. august 2026

Først lagt ut (Faktiske)

10. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026STI341 (Registeridentifikator: National Engineering Research Center of Science and Technology Information STI Digital Health Laboratory)

Plan for individuelle deltakerdata (IPD)

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UBESLUTTE

IPD-planbeskrivelse

The individual participant data sharing plan has not yet been determined and will be decided according to institutional policy, ethics committee requirements, and participant privacy considerations.

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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