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

September 25, 2025 updated by: Microvention-Terumo, Inc.
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Hollywood, Florida, United States, 33021
        • Memorial Healthcare System
      • Orlando, Florida, United States, 32806
        • Orlando Health
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with ruptured or unruptured intracranial aneurysms who will be treated endovascularly with commercially available MicroVention devices at the direction of the treating physician.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RROC
Time Frame: 1 year
Angiographic aneurysm occlusion (RROC) at 1 year
1 year
RROC
Time Frame: 1 year
Angiographic aneurysm occlusion (RROC) at 1 year without rebleed (ruptured aneurysms only)
1 year
RROC
Time Frame: 1 year
Angiographic aneurysm occlusion (RROC) at 1 year without rebleed (ruptured aneurysms only) or retreatment for residual aneurysm
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Microvention-Terumo, Inc.

Investigators

  • Principal Investigator: TBD TBD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2024

Primary Completion (Estimated)

January 8, 2029

Study Completion (Estimated)

January 8, 2029

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 25, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL11025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aneurysm Cerebral

Clinical Trials on Intracranial Aneurysm Devices

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe