Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

4 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

274

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
      • Guangzhou, Cina
        • Reclutamento
        • Zhujiang Hospital, Southern Medical University
        • Contatto:
      • Guangzhou, Cina
        • Reclutamento
        • Guangdong Province People's Hospital
        • Contatto:
    • Guangdong
      • Guangzhou, Guangdong, Cina
        • Reclutamento
        • Nanfang Hospital, Southern Medical University
        • Contatto:
          • Wenfeng Feng Feng, Principal Investigator, MD
          • Numero di telefono: 13501509911
          • Email: fengwf1967@163.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Flow Diverter Group
Patients with unruptured wide-neck intracranial bifurcation aneurysms who receive flow diverter treatment in routine clinical practice.
Dispositivo: 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.
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Composite incidence of any stroke or all-cause death within 30 days after procedure
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of any stroke within 30 days after procedure
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Nanfang Hospital, Southern Medical University

Collaboratori

Zhujiang Hospital
Guangdong Province People's Hospital

Investigatori

  • Investigatore principale: Wenfeng Feng, MD, Nanfang Hospital, Southern Medical University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

19 marzo 2026

Completamento primario (Stimato)

19 marzo 2027

Completamento dello studio (Stimato)

19 marzo 2028

Date di iscrizione allo studio

Primo inviato

4 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 agosto 2026

Primo Inserito (Effettivo)

10 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi