Real-world outcomes of MicroVention devices for intracranial aneurysm treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry gathers data on functional, imaging, and safety outcomes from patients treated with MicroVention intracranial aneurysm devices. Data come from routine clinical care, without randomization or a predefined experimental protocol. The study focuses on outcomes after endovascular treatment and aims to reflect everyday practice. Ancillary devices used during procedures are not counted as primary treatment devices. Participation requires informed consent and follow-up visits as determined by treating physicians.

Why it matters

Who can join: the full rules

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.

Where it's running

• Walnut Creek Medical Center
  Walnut Creek, California, United States Recruiting
• Swedish Medical Center
  Englewood, Colorado, United States Recruiting
• Hartford Hospital
  Hartford, Connecticut, United States Recruiting
• Broward Health Medical Center
  Fort Lauderdale, Florida, United States Recruiting
• Memorial Regional Hospital
  Hollywood, Florida, United States Recruiting
• Baptist Medical Center, Jacksonville
  Jacksonville, Florida, United States Recruiting

Study contacts

• Principal investigator: Alexandra Paul, MD — Albany Medical College
• Study coordinator: Robert Gash
• Email: robert.gash@microvention.com
• Phone: 908-914-1045

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.