Recruiting

MicroVention Devices

Sponsor:

Microvention-Terumo, Inc.

Code:

NCT06215105

Conditions

Cerebral Aneurysm

Intracranial Aneurysms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Commercially available MicroVention Intracranial Aneurysm Treatment Devices

Study Details

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

Cerebral Aneurysm

Intracranial Aneurysms

Study ID

NCT06215105

Start date

Feb 19, 2024

Status verified date

Nov, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

1. Patient must have a single ruptured or unruptured IA for which endovascular treatment has been determined appropriate.
2. Patient 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 and no later than 48 hours post procedure for emergent treatment of ruptured aneurysms.
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 Design

Enrollment

750 participants

Anticipated

Interventions and Outcome Measures

Interventions

Commercially available MicroVention Intracranial Aneurysm Treatment Devices

Commercially available MicroVention intracranial aneurysm treatment devices used in routine clinical practice for the endovascular treatment of intracranial aneurysms. Device selection and treatment decisions are made by the treating physician according to standard clinical practice and are not assigned by the registry.

Primary outcome measure

  • RROC [ Time Frame: 1 year ]
  • RROC [ Time Frame: 1 year ]
  • RROC [ Time Frame: 1 year ]

Central Contacts and Locations

Locations

Walnut Creek Medical Center

Recruiting

Walnut Creek, California, United States, 94598

Principal Investigator:

Benjamin Yim

Swedish Medical Center

Recruiting

Englewood, Colorado, United States, 80113

Principal Investigator:

Eric Arias

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06106

Principal Investigator:

Tapan Mehta

Broward Health Medical Center

Recruiting

Fort Lauderdale, Florida, United States, 33316

Principal Investigator:

Mehdi Bouslama

Memorial Regional Hospital

Recruiting

Hollywood, Florida, United States, 33021

Principal Investigator:

Brijesh Mehta

Baptist Medical Center, Jacksonville

Recruiting

Jacksonville, Florida, United States, 32207

Principal Investigator:

Ricardo Hanel

Mount Sinai Medical Center - Miami

Recruiting

Miami Beach, Florida, United States, 33140

Principal Investigator:

Vasu Saini

Orlando Regional Medical Center

Recruiting

Orlando, Florida, United States, 32806

Principal Investigator:

Jay Vachhani

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Principal Investigator:

Kunal Vakharia

The Queen's Medical Center Neuroscience Institute

Recruiting

Honolulu, Hawaii, United States, 96813

Principal Investigator:

Ferdinand Hui

University of Iowa Hospitals & Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Principal Investigator:

Edgar Samaniego

Norton Neuroscience Institute

Recruiting

Louisville, Kentucky, United States, 40241

Principal Investigator:

Tom Yao

Munson Medical Center

Recruiting

Traverse City, Michigan, United States, 49684

Principal Investigator:

Brent Flusty

Abbott Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Principal Investigator:

Josser Delgado

Albany Medical Center

Recruiting

Albany, New York, United States, 12208

Principal Investigator:

Alexandra Paul

North Shore University Hospital

Recruiting

Great Neck, New York, United States, 11021

Principal Investigator:

Timothy White

The Mount Sinai Hospital - New York City

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Tomoyoshi Shigematsu

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Principal Investigator:

David Altschul

Mayfield Clinic

Recruiting

Cincinnati, Ohio, United States, 45209

Principal Investigator:

Andrew Ringer

Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Principal Investigator:

Patrick Youssef

ProMedica Toledo Hospital

Recruiting

Toledo, Ohio, United States, 43606

Principal Investigator:

Mouhammad Jumaa

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Principal Investigator:

Hakeem Shakir

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Principal Investigator:

Alejandro Spiotta

Prisma Health Greenville Memorial Hospital

Recruiting

Greenville, South Carolina, United States, 29605

Principal Investigator:

Mohammad Imran Chaudry

Fort Sanders Regional Medical Center

Recruiting

Knoxville, Tennessee, United States, 37916

Principal Investigator:

Keith Woodward

West Virginia University Hospital

Recruiting

Morgantown, West Virginia, United States, 26506

Principal Investigator:

Ryan Turner

Advocate Aurora St. Lukes Medical Center

Recruiting

Milwaukee, Wisconsin, United States, 53215

Principal Investigator:

Sudeepta Dandapat

More Information

Sponsor

Microvention-Terumo, Inc.

Last update posted

Nov 10, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-11. This information was provided to ClinicalTrials.gov by Microvention-Terumo, Inc. on 2026-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.