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

NCT06215105 | Enrolling By Invitation FDA Device

• 1 other identifier: CL11025
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Aneurysm Cerebral

Outcome Measures

Primary Outcomes (3)

• RROC

  Angiographic aneurysm occlusion (RROC) at 1 year

  1 year

• RROC

  Angiographic aneurysm occlusion (RROC) at 1 year without rebleed (ruptured aneurysms only)

  1 year

• RROC

  Angiographic aneurysm occlusion (RROC) at 1 year without rebleed (ruptured aneurysms only) or retreatment for residual aneurysm

  1 year

Interventions

Intracranial Aneurysm Devices DEVICE

Intracranial Aneurysm occlusion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient must have a single ruptured or unruptured IA for which endovascular treatment has been determined appropriate.
• 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.
• 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.
• Patient must be considered by the treating physician to be available for and able to complete study follow-up visits.

You may not qualify if:

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

Sponsors & Collaborators

• Microvention-Terumo, Inc.: lead

Study Sites (5)

Memorial Healthcare System

Hollywood, Florida, 33021, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• TBD TBD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 22, 2024
• Study Start: January 8, 2024
• Primary Completion (Estimated): January 8, 2029
• Study Completion (Estimated): January 8, 2029
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

US (5)