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OpenTrials
Enrolling by Invitation

NCT Number: NCT06215105

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

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.

Enrolling by Invitation

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Healthcare System, Hollywood, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Intracranial Aneurysm Devices

Device

Intracranial Aneurysm occlusion

Primary outcomes

  1. RROC

    Time frame: 1 year

    Angiographic aneurysm occlusion (RROC) at 1 year

  2. RROC

    Time frame: 1 year

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

  3. RROC

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Microvention-Terumo, Inc.

Industry

Registry information

Acronym: CAR

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jan 22, 2024
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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