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

NCT07754188 | Recruiting DMC

• 1 other identifier: 2026STI341
• Study Type: observational
• Target: 274
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Intracranial bifurcation aneurysm; Wide-neck aneurysm; Flow diverter; Stent-assisted coiling; Endovascular treatment; Early complications; Stroke; All-cause mortality; Real-world study; Prospective cohort

Outcome Measures

Primary Outcomes (1)

• Composite incidence of any stroke or all-cause death 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

Secondary Outcomes (4)

• Incidence of any stroke within 30 days after procedure

  Within 30 days after procedure

• Incidence of transient ischemic attack within 30 days after procedure

  Within 30 days after procedure

• Incidence of all-cause death within 30 days after procedure

  Within 30 days after procedure

• Incidence of adverse events and serious adverse events within 30 days after procedure

  Within 30 days after procedure

Study Arms (2)

Flow Diverter Group

Patients with unruptured wide-neck intracranial bifurcation aneurysms who receive flow diverter treatment in routine clinical practice.

Device: Flow Diverter

Stent-Assisted Coiling Group

Patients with unruptured wide-neck intracranial bifurcation aneurysms who receive stent-assisted coiling in routine clinical practice.

Device: Stent-Assisted Coiling

Interventions

Flow Diverter DEVICE

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.

Flow Diverter Group

Stent-Assisted Coiling DEVICE

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.

Stent-Assisted Coiling Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Zhujiang Hospital: collaborator
• Guangdong Province People's Hospital: collaborator

Study Sites (3)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

Guangdong Province People's Hospital

Guangzhou, China

RECRUITING

Zhujiang Hospital, Southern Medical University

Guangzhou, China

RECRUITING

Related Publications (30)

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MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Wenfeng Feng, MD

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huibin Kang Study Contact, MD

CONTACT

13520296286; kanghuibindoctor@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 10, 2026
• Study Start: March 19, 2026
• Primary Completion (Estimated): March 19, 2027
• Study Completion (Estimated): March 19, 2028
• Last Updated: August 10, 2026

Record last verified: 2026-08

Locations

CN (3)