Flow-diverting stents for distal brain aneurysms

Multicenter Study to Evaluate the Effectiveness and Safety of Flow-Diverting Stents for Distal Intracranial Aneurysms

This will see if flow-diverting stents are safe and work well for adults (18–80) treated for distal brain aneurysms.

Quick facts

• Study type: Observational
• Enrollment: 164 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07376590 on ClinicalTrials.gov

What this trial studies

This observational registry collects clinical and imaging data from adults aged 18–80 who receive flow-diverting stents for distal intracranial aneurysms. Eligible aneurysms include wide-neck saccular, fusiform, recurrent saccular, and dissecting aneurysms in distal branches of the Circle of Willis (for example MCA M1–M3, ACA A1–A3, PCA P1–P2). The study records procedural details, peri-procedural complications, and follow-up angiographic occlusion and clinical outcomes to characterize real-world safety and effectiveness. No experimental interventions are assigned and treatment follows local clinical practice while outcomes are analyzed.

Who should consider this trial

Good fit: Adults 18–80 diagnosed with a distal intracranial aneurysm (wide-neck, dome-to-neck ratio <2, saccular/fusiform/recurrent/dissecting) who are treated with a flow-diverting stent and can provide informed consent.

Not a fit: Patients outside the age range, those not treated with a flow diverter, or those whose parent artery anatomy (severe stenosis or extreme tortuosity) prevents safe stent delivery are unlikely to benefit from participation.

Why it matters

Potential benefit: If positive, the data could support safer use of flow-diverting stents in distal vessels and help doctors choose the best treatment for these aneurysms.

How similar studies have performed: Flow-diverting stents are well established for certain proximal intracranial aneurysms, but evidence for their safety and efficacy in distal vessels is limited to small case series and is not yet definitive.

Eligibility criteria

Inclusion Criteria:

1. Age 18 to 80 years, any gender，Subjects who have accepted treatment with flow-diverting for distal intracranial aneurysms
2. Diagnosed with an intracranial aneurysm by CTA, MRA, or DSA, with the following features: a wide neck (≥4mm), or a dome-to-neck ratio \<2, saccular, fusiform aneurysms, recurrent saccular aneurysms, and dissecting aneurysms. Locations include: the Circle of Willis and it's distal branches such as the middle cerebral artery (MCA) M1-M3 segments, anterior cerebral artery (ACA) A1-A3 segments, posterior cerebral artery (PCA) P1-P2 segments, etc. (intracranial aneurysms of the Circle of Willis and it's distal vessels).
3. Subject or guardian is able to understand the purpose of study, shows sufficient compliance with the study protocol and provides a signed informed consent form

Exclusion Criteria:

1. Conditions that are not appropriate for stent delivery and deployment judged by investigators (severe stenosis of parent artery, severe tortuosity of parent artery, stent failing to reach the lesion, stent in the target lesion of parent artery, etc.)
2. mRS score ≥3
3. Heart, lung, liver and renal failure or other severe diseases (intracranial tumor, systemic infection, disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe psychosis, severe stenosis or occlusion of cerebral feeding artery, etc.)
4. Platelet count \<60×10\^9/L, known platelet dysfunction, or international normalized ratio (INR) \>1.5
5. Major surgery within 30 days before enrollment，or planned to undergo surgery within 360 days after enrollment
6. Known allergies or contraindications to anesthetics, anticoagulants, and antiplatelet drugs
7. Pregnant or breastfeeding women
8. Subject has participated in other clinical trials within 1 month before signing informed consent
9. Other conditions judged by the investigators as unsuitable for enrollment

Where this trial is running

Hangzhou, Zhejiang

• First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: yuanyuan Shen

Conditions Aneurysms