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Multicenter Study to Evaluate the Effectiveness and Safety of Flow-Diverting Stents for Distal Intracranial Aneurysms | Clinical Trials | Clareo Health

RECRUITING

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

NCT07376590•First Affiliated Hospital of Zhejiang University

View on ClinicalTrials.gov

Summary

Using data obtained from the treatment of intracranial distal intracranial aneurysms with flow diverter, evaluate the effecy and safety of blood flow diverter for the endovascular treatment of distal intracranial aneurysms.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Key Dates

Start Date

January 15, 2026

Primary Completion Date

December 31, 2027

Completion Date

December 31, 2027

Last Updated

January 29, 2026

Enrollment

164

ESTIMATED participants

Conditions

Aneurysms

Interventions

No intervention measures

DEVICE

Contacts

yuanyuan Shen

CONTACT

13958020971 y.shen@zju.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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