ClinicalTrials.gg
RecruitingNCT06215105CARUpdated Nov 10, 2026

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

An observational study in Cerebral Aneurysm and Intracranial Aneurysms, sponsored by Microvention-Terumo, Inc.. Recruiting at 27 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Microvention-Terumo, Inc. (part of Terumo Corporation) · Observational

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 8 months later.
Updated Nov 10, 2026Now RecruitingSite recruiting status changed+7 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
750
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cerebral Aneurysm
  • Intracranial Aneurysms

Browse trials for

03

In context

Intracranial Aneurysm

418 studies on the registry are indexed under Intracranial Aneurysm; 119 are open to participants now.

This study's planned enrollment of 750 is above the median of 200 across 191 observational studies indexed under Intracranial Aneurysm.

Browse Intracranial Aneurysm studies →

Lead sponsor

Microvention-Terumo, Inc. is the lead sponsor of 32 studies on the registry; 7 are open to participants now.

First submitted after Microvention-Terumo, Inc. became part of Terumo Corporation.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Nov 10, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
750 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Interventions

  • DeviceCommercially 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.

06

What researchers measure

Primary outcomes

  1. RROC

    Angiographic aneurysm occlusion (RROC) at 1 year

    Time frame: 1 year

  2. RROC

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

    Time frame: 1 year

  3. RROC

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

    Time frame: 1 year

07

Study locations

27 of 27 sites recruiting
  • Walnut Creek Medical Center
    Walnut Creek, California 94598, United States
    Recruiting
    • Melenie Aaron · Contact
    • Benjamin Yim · Principal investigator
  • Swedish Medical Center
    Englewood, Colorado 80113, United States
    Recruiting
    • Ashley Thompson · Contact
    • Eric Arias · Principal investigator
  • Hartford Hospital
    Hartford, Connecticut 06106, United States
    Recruiting
    • Aditya Vajja · Contact
    • Tapan Mehta · Principal investigator
  • Broward Health Medical Center
    Fort Lauderdale, Florida 33316, United States
    Recruiting
    • Laura Hudson · Contact
    • Mehdi Bouslama · Principal investigator
  • Memorial Regional Hospital
    Hollywood, Florida 33021, United States
    Recruiting
    • Belkis Wandique, BSN, RN · Contact
    • Brijesh Mehta · Principal investigator
  • Baptist Medical Center, Jacksonville
    Jacksonville, Florida 32207, United States
    Recruiting
    • Montserrat Lara Petrick · Contact
    • Ricardo Hanel · Principal investigator
  • Mount Sinai Medical Center - Miami
    Miami Beach, Florida 33140, United States
    Recruiting
    • Juan Vinardell Lorenzo · Contact
    • Vasu Saini · Principal investigator
  • Orlando Regional Medical Center
    Orlando, Florida 32806, United States
    Recruiting
    • Diana Mondragon · Contact
    • Jay Vachhani · Principal investigator
  • Tampa General Hospital
    Tampa, Florida 33606, United States
    Recruiting
    • Shalini Nampally · Contact
    • Kunal Vakharia · Principal investigator
  • The Queen's Medical Center Neuroscience Institute
    Honolulu, Hawaii 96813, United States
    Recruiting
    • Kelly Diedrich · Contact
    • Ferdinand Hui · Principal investigator
  • University of Iowa Hospitals & Clinics
    Iowa City, Iowa 52242, United States
    Recruiting
    • Heena Olalde · Contact
    • Edgar Samaniego · Principal investigator
  • Norton Neuroscience Institute
    Louisville, Kentucky 40241, United States
    Recruiting
    • Trina DeForrest · Contact
    • Tom Yao · Principal investigator
  • Munson Medical Center
    Traverse City, Michigan 49684, United States
    Recruiting
    • DeAnn Mosher · Contact
    • Brent Flusty · Principal investigator
  • Abbott Northwestern Hospital
    Minneapolis, Minnesota 55407, United States
    Recruiting
    • Nimco Essa · Contact
    • Josser Delgado · Principal investigator
  • Albany Medical Center
    Albany, New York 12208, United States
    Recruiting
    • Wendy Stewart · Contact
    • Alexandra Paul · Principal investigator
  • North Shore University Hospital
    Great Neck, New York 11021, United States
    Recruiting
    • Betsy Monclair · Contact
    • Timothy White · Principal investigator
  • The Mount Sinai Hospital - New York City
    New York, New York 10029, United States
    Recruiting
    • Emily Svednesen · Contact
    • Tomoyoshi Shigematsu · Principal investigator
  • Montefiore Medical Center
    The Bronx, New York 10467, United States
    Recruiting
    • Genesis Liriano · Contact
    • David Altschul · Principal investigator
  • Mayfield Clinic
    Cincinnati, Ohio 45209, United States
    Recruiting
    • Lauren Murphy · Contact
    • Andrew Ringer · Principal investigator
  • Ohio State University Wexner Medical Center
    Columbus, Ohio 43210, United States
    Recruiting
    • Uchechi Okafor · Contact
    • Patrick Youssef · Principal investigator
  • ProMedica Toledo Hospital
    Toledo, Ohio 43606, United States
    Recruiting
    • Jennifer Dura · Contact
    • Mouhammad Jumaa · Principal investigator
  • University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma 73104, United States
    Recruiting
    • Michael Omini · Contact
    • Hakeem Shakir · Principal investigator
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
    Recruiting
    • Meredith Robinson · Contact
    • Alejandro Spiotta · Principal investigator
  • Prisma Health Greenville Memorial Hospital
    Greenville, South Carolina 29605, United States
    Recruiting
    • Shawn Manos · Contact
    • Mohammad Imran Chaudry · Principal investigator
  • Fort Sanders Regional Medical Center
    Knoxville, Tennessee 37916, United States
    Recruiting
    • Cameron Carter · Contact
    • Keith Woodward · Principal investigator
  • West Virginia University Hospital
    Morgantown, West Virginia 26506, United States
    Recruiting
    • Jennifer Domico · Contact
    • Ryan Turner · Principal investigator
  • Advocate Aurora St. Lukes Medical Center
    Milwaukee, Wisconsin 53215, United States
    Recruiting
    • Stacie Bishop · Contact
    • Sudeepta Dandapat · Principal investigator
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2024 (actual). Primary completion is estimated for Jan 2029, 59 months after the start.

Of 104 observational studies under Intracranial Aneurysm, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 145. This study's planned 59 months is above that.

Start moved once since we started tracking on Sep 25, 2026: Jan 2024 → Feb 2024, on Nov 10, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jan 10, 2024
First posted
Jan 22, 2024
StartActual
Feb 19, 2024was Jan 2024
Primary completionEst.
Jan 2029
CompletionEst.
Jan 2029
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Enrolling by invitation→Recruiting
changed Nov 10, 2026
Sites
25 sites added, 3 sites removed. 2 sites changed recruiting status (2 now recruiting)
Show 2 sites
  • Abbott Northwestern Hospital · Minneapolis, United Statesno status→Recruiting
  • Albany Medical Center · Albany, United Statesno status→Recruiting
Show 25 added (25 United States)
  • Walnut Creek Medical Center · Walnut Creek, United States
  • Swedish Medical Center · Englewood, United States
  • Hartford Hospital · Hartford, United States
  • Broward Health Medical Center · Fort Lauderdale, United States
  • Memorial Regional Hospital · Hollywood, United States
  • Baptist Medical Center, Jacksonville · Jacksonville, United States
  • Mount Sinai Medical Center - Miami · Miami Beach, United States
  • Orlando Regional Medical Center · Orlando, United States
  • Tampa General Hospital · Tampa, United States
  • The Queen's Medical Center Neuroscience Institute · Honolulu, United States
  • University of Iowa Hospitals & Clinics · Iowa City, United States
  • Norton Neuroscience Institute · Louisville, United States
  • Munson Medical Center · Traverse City, United States
  • North Shore University Hospital · Great Neck, United States
  • The Mount Sinai Hospital - New York City · New York, United States
  • Montefiore Medical Center · The Bronx, United States
  • Mayfield Clinic · Cincinnati, United States
  • Ohio State University Wexner Medical Center · Columbus, United States
  • ProMedica Toledo Hospital · Toledo, United States
  • University of Oklahoma Health Sciences Center · Oklahoma City, United States
  • Medical University of South Carolina · Charleston, United States
  • Prisma Health Greenville Memorial Hospital · Greenville, United States
  • Fort Sanders Regional Medical Center · Knoxville, United States
  • West Virginia University Hospital · Morgantown, United States
  • Advocate Aurora St. Lukes Medical Center · Milwaukee, United States
Show 3 removed
  • Memorial Healthcare System · Hollywood, United States
  • Orlando Health · Orlando, United States
  • University of Iowa · Iowa City, United States
Nov 10, 2026
Start date
Jan 8, 2024→Feb 19, 2024
Nov 10, 2026
Eligibility
Minimum age none→18 Years; 2 inclusion criteria edited, 1 removed
What changed in the criteria
Inclusion criteria
  • EditedPatient'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.
  • RemovedNote: For the purposes of this protocol, ancillary/accessory devices such as balloon catheters and other access devices are not considered primary treatment devices.
  • EditedPatient or patient 's legally authorized representative (LAR) has provided written informed consent prior to treatment orand no later than 48 hours post procedure for emergent treatment of a ruptured aneurysmaneurysms.
Nov 10, 2026
Interventions
Changed Intracranial Aneurysm Devices→Commercially available MicroVention Intracranial Aneurysm Treatment Devices
Nov 10, 2026
Contact
Study contact now listed: added r•••@microvention.com · •••1045. See the current contact
Nov 10, 2026
Site contacts
Changed at 2 sites. See the sites
Show 2 sites
  • Abbott Northwestern Hospital · Minneapolis, United StatesContact added (no phone or email listed)Contact added (no phone or email listed)
  • Albany Medical Center · Albany, United StatesContact added (no phone or email listed)Contact added (no phone or email listed)
Nov 10, 2026
Title
Complex Aneurysm Registry - Real-World Evidence Data Collection for Intracranial Aneurysm Treatment Devices
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    Enrolling by invitation→Recruiting
    25 sites added, 3 sites removed. 2 sites changed recruiting status (2 now recruiting)
    Show 2 sites
    • Abbott Northwestern Hospital · Minneapolis, United Statesno status→Recruiting
    • Albany Medical Center · Albany, United Statesno status→Recruiting
    Show 25 added (25 United States)
    • Walnut Creek Medical Center · Walnut Creek, United States
    • Swedish Medical Center · Englewood, United States
    • Hartford Hospital · Hartford, United States
    • Broward Health Medical Center · Fort Lauderdale, United States
    • Memorial Regional Hospital · Hollywood, United States
    • Baptist Medical Center, Jacksonville · Jacksonville, United States
    • Mount Sinai Medical Center - Miami · Miami Beach, United States
    • Orlando Regional Medical Center · Orlando, United States
    • Tampa General Hospital · Tampa, United States
    • The Queen's Medical Center Neuroscience Institute · Honolulu, United States
    • University of Iowa Hospitals & Clinics · Iowa City, United States
    • Norton Neuroscience Institute · Louisville, United States
    • Munson Medical Center · Traverse City, United States
    • North Shore University Hospital · Great Neck, United States
    • The Mount Sinai Hospital - New York City · New York, United States
    • Montefiore Medical Center · The Bronx, United States
    • Mayfield Clinic · Cincinnati, United States
    • Ohio State University Wexner Medical Center · Columbus, United States
    • ProMedica Toledo Hospital · Toledo, United States
    • University of Oklahoma Health Sciences Center · Oklahoma City, United States
    • Medical University of South Carolina · Charleston, United States
    • Prisma Health Greenville Memorial Hospital · Greenville, United States
    • Fort Sanders Regional Medical Center · Knoxville, United States
    • West Virginia University Hospital · Morgantown, United States
    • Advocate Aurora St. Lukes Medical Center · Milwaukee, United States
    Show 3 removed
    • Memorial Healthcare System · Hollywood, United States
    • Orlando Health · Orlando, United States
    • University of Iowa · Iowa City, United States
    Start date Jan 8, 2024→Feb 19, 2024
    Eligibility Minimum age none→18 Years; 2 inclusion criteria edited, 1 removed
    What changed in the criteria
    Inclusion criteria
    • EditedPatient'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.
    • RemovedNote: For the purposes of this protocol, ancillary/accessory devices such as balloon catheters and other access devices are not considered primary treatment devices.
    • EditedPatient or patient 's legally authorized representative (LAR) has provided written informed consent prior to treatment orand no later than 48 hours post procedure for emergent treatment of a ruptured aneurysmaneurysms.
    Interventions Changed Intracranial Aneurysm Devices→Commercially available MicroVention Intracranial Aneurysm Treatment Devices
    Contact Study contact now listed: added r•••@microvention.com · •••1045. See the current contact
    Site contacts Changed at 2 sites. See the sites
    Show 2 sites
    • Abbott Northwestern Hospital · Minneapolis, United StatesContact added (no phone or email listed)Contact added (no phone or email listed)
    • Albany Medical Center · Albany, United StatesContact added (no phone or email listed)Contact added (no phone or email listed)
    Title Complex Aneurysm Registry - Real-World Evidence Data Collection for Intracranial Aneurysm Treatment Devices
    + 3 other changes: verification date, oversight details and conditions

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06215105
Responsible party
Sponsor
First posted
Jan 22, 2024
Start date
Feb 19, 2024
Primary completion
Jan 2029 (estimated)
Completion
Jan 2029 (estimated)
Last update
Nov 10, 2026

Study contacts

Robert Gash
Contact
robert.gash@microvention.com
908-914-1045
Alexandra Paul, MD
principal investigator · Albany Medical College
Edgar Samaniego, MD, MS
principal investigator · University of Iowa Hospitals & Clinics

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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