Aneurysm CerebralCARNCT06215105
Complex Aneurysm Registry - Real-World Evidence Data Collection Intracranial Aneurysm Treatment Devices
An observational study of Aneurysm Cerebral, run by Microvention-Terumo, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Aneurysm Cerebral
- What is being tested?
- Intracranial Aneurysm Devices
- Type of treatment
- Medical device
- How many people
- 750 participants
- Where
- 5 sitesUnited States
- Study dates
- 8 Jan 2024to 8 Jan 2029
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
Albany Medical Center
Albany, New York, 12208
Memorial Healthcare System
Hollywood, Florida, 33021
University of Iowa
Iowa City, Iowa, 52242
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Orlando Health
Orlando, Florida, 32806
About this study
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
- Being tested
- Intracranial Aneurysm Devices
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracranial Aneurysm DevicesDevice
Intracranial Aneurysm occlusion
What is being measured
The primary outcome is the main question the study is designed to answer.
RROC
Angiographic aneurysm occlusion (RROC) at 1 year
Measured: 1 year
RROC
Angiographic aneurysm occlusion (RROC) at 1 year without rebleed (ruptured aneurysms only)
Measured: 1 year
RROC
Angiographic aneurysm occlusion (RROC) at 1 year without rebleed (ruptured aneurysms only) or retreatment for residual aneurysm
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start8 Jan 2024
- Primary completion8 Jan 2029 (estimated)
- Study completion8 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm CerebralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Microvention-Terumo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- TBD TBD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215105
- Sponsor's protocol ID
- CL11025
- Acronym
- CAR
- Status last verified
- Sep 2025
- First submitted
- 10 Jan 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Aneurysm Registry - Real-World Evidence Data Collection Intracranial Aneurysm Treatment Devices
- ClinicalTrials.gov ID
- NCT06215105
- Acronym / sponsor ID
- CAR / CL11025
- Conditions
- Aneurysm Cerebral
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 8 Jan 2029 (estimated)
- Study completion
- 8 Jan 2029 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracranial Aneurysm DevicesIntracranial Aneurysm occlusion | Device | – |
Primary outcome
RROC
Time frame: 1 year
Angiographic aneurysm occlusion (RROC) at 1 year
RROC
Time frame: 1 year
Angiographic aneurysm occlusion (RROC) at 1 year without rebleed (ruptured aneurysms only)
RROC
Time frame: 1 year
Angiographic aneurysm occlusion (RROC) at 1 year without rebleed (ruptured aneurysms only) or retreatment for residual aneurysm
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
TBD TBD principal investigator
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm Cerebral, run by Microvention-Terumo, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RROC (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.