FRED Retrospective Study of Intracranial Aneurysms Treatment

NCT ID: NCT06982781

Last Updated: 2025-05-21

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-31

Study Completion Date

2027-05-06

Brief Summary

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To evaluate the long-term safety and efficacy of Flow Re-Direction Endoluminal Device System (FRED) in the treatment of intracranial aneurysms in the post-market environment

Detailed Description

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Study Objective: To evaluate the long-term safety and efficacy of Flow Re-Direction Endoluminal Device System (FRED) in the treatment of intracranial aneurysms in the post-market.

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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Intracranial Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* People in China mainland who have been treated with FRED. The patients for whom clinical data are available
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Microvention-Terumo, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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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Brook Li

Role: CONTACT

86 138 918 55337

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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CL1106094

Identifier Type: -

Identifier Source: org_study_id

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