FRED Retrospective Study of Intracranial Aneurysms Treatment
NCT ID: NCT06982781
Last Updated: 2025-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
2000 participants
OBSERVATIONAL
2025-05-31
2027-05-06
Brief Summary
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Detailed Description
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Study Design: Post-market, retrospective, multi-center, observational clinical study Study Population: Patient who has implanted at least one observational device in China mainland.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Flow Re-Direction Endoluminal Device System(FRED)
Flow Diverter (FD) devices are developed based on reconstructing the parent artery's lumen. FDs are designed with a denser mesh compared to conventional intracranial stents. By covering the aneurysm neck, these stents redirect blood flow away from the aneurysm, promoting intra-aneurysmal flow stagnation and subsequent thrombosis formation. Currently, FDs are primarily used for the treatment of wide-neck aneurysms.
Eligibility Criteria
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Inclusion Criteria
18 Years
90 Years
ALL
No
Sponsors
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Microvention-Terumo, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Tianxiao Li
Role: PRINCIPAL_INVESTIGATOR
Henan Provincial People's Hospital
Sheng Guan
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Zhengzhou University
Central Contacts
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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CL1106094
Identifier Type: -
Identifier Source: org_study_id
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