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Early Complications After Flow Diverter Versus Stent-Assisted Coiling for Unruptured Wide-Neck Intracranial Bifurcation Aneurysms

NCT07754188 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 274

Last updated 2026-08-10

No results posted yet for this study

Summary

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.

Conditions

  • Unruptured Intracranial Aneurysm
  • Intracranial Bifurcation Aneurysm
  • Wide-Neck Aneurysm

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • Zhujiang Hospital

    collaborator OTHER

  • Guangdong Province People's Hospital

    collaborator UNKNOWN

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Wenfeng Feng, MD · Nanfang Hospital, Southern Medical University

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-19
Primary Completion
2027-03-19
Completion
2028-03-19

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07754188 on ClinicalTrials.gov