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

Aneurysm Cerebral Clinical Trial

— CAR  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06215105
• Other study ID #: CL11025
• Status: Enrolling by invitation
• Start date: January 8, 2024
• Est. completion date: January 8, 2029

Study information

• Verified date: April 2024
• Source: Microvention-Terumo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 750
• Est. completion date: January 8, 2029
• Est. primary completion date: January 8, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm Cerebral
• Intracranial Aneurysm

Intervention

Device:
• Intracranial Aneurysm Devices
Intracranial Aneurysm occlusion

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Microvention-Terumo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RROC	Angiographic aneurysm occlusion (RROC) at 1 year	1 year
Primary	RROC	Angiographic aneurysm occlusion (RROC) at 1 year without rebleed (ruptured aneurysms only)	1 year
Primary	RROC	Angiographic aneurysm occlusion (RROC) at 1 year without rebleed (ruptured aneurysms only) or retreatment for residual aneurysm	1 year