Complex Aneurysm Registry - Real-World Evidence Data Collection Intracranial Aneurysm Treatment Devices

NCT ID: NCT06215105

Last Updated: 2025-10-01

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

ENROLLING_BY_INVITATION

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-08

Study Completion Date

2029-01-08

Brief Summary

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To collect real-world evidence allowing assessment of functional, imaging, and safety outcomes of commercially available MicroVention devices used for the endovascular treatment of intracranial aneurysms (IA) at the direction of the treating physician.

Detailed Description

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Conditions

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Aneurysm Cerebral

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Intracranial Aneurysm Devices

Intracranial Aneurysm occlusion

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patient must have a single ruptured or unruptured IA for which endovascular treatment has been determined appropriate.
2. Patient's IA will be treated using a commercially available MicroVention implant device as the primary treatment device and the decision to use this device has been made by the treating physician outside the context of the CAR study and prior to enrollment.

Note: For the purposes of this protocol, ancillary/accessory devices such as balloon catheters and other access devices are not considered primary treatment devices.
3. Patient or patient 's legally authorized representative (LAR) has provided written informed consent prior to treatment or no later than 48 hours post procedure for emergent treatment of a ruptured aneurysm.
4. Patient must be considered by the treating physician to be available for and able to complete study follow-up visits.

Exclusion Criteria

1. Target aneurysm has been previously treated via surgical or endovascular means.
2. Patient is enrolled in another device or drug study in which participation could confound study results.
3. Patient has a life expectancy of less than 1 year due to other illness or condition (in addition to an intracranial aneurysm).
4. Patient has been previously enrolled into this study.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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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TBD TBD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Memorial Healthcare System

Hollywood, Florida, United States

Site Status

Orlando Health

Orlando, Florida, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status

Albany Medical Center

Albany, New York, United States

Site Status

Countries

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United States

Other Identifiers

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CL11025

Identifier Type: -

Identifier Source: org_study_id

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