This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

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

Sponsored by Microvention-Terumo, Inc.

About this trial

Last updated 7 months ago

Study ID

CL11025

Status

Enrolling by invitation

Type

Observational

Placebo

No

Accepting

All Ages
All Sexes

Trial Timing

Started 2 years ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

1. Patient must have a single ruptured or unruptured IA for which endovascular treatment has been determined appropriate.

2. 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.

3. 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.

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.