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

Brief 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.
Brief Title
Complex Aneurysm Registry - Real-World Evidence Data Collection Intracranial Aneurysm Treatment Devices
Completion Date
Completion Date Type
Estimated
Conditions
Aneurysm Cerebral
Eligibility Criteria
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.
Inclusion Criteria
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.

Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Submit Date
NCT Id
NCT06215105
Org Class
Industry
Org Full Name
Microvention-Terumo, Inc.
Org Study Id
CL11025
Overall Status
Enrolling by invitation
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Complex Aneurysm Registry - Real-World Evidence Data Collection Intracranial Aneurysm Treatment Devices
Primary Outcomes
Outcome Description
Angiographic aneurysm occlusion (RROC) at 1 year
Outcome Measure
RROC
Outcome Time Frame
1 year
Outcome Description
Angiographic aneurysm occlusion (RROC) at 1 year without rebleed (ruptured aneurysms only)
Outcome Measure
RROC
Outcome Time Frame
1 year
Outcome Description
Angiographic aneurysm occlusion (RROC) at 1 year without rebleed (ruptured aneurysms only) or retreatment for residual aneurysm
Outcome Measure
RROC
Outcome Time Frame
1 year
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
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.
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
David Altschul
Investigator Email
daltschu@montefiore.org
Investigator Phone
718-920-7498
Investigator Department
Neurological Surgery
Investigator Sponsor Organization
External
Study Department
Neurological Surgery
Study Division
Not Applicable
Categories Mesh Debug
Brain, Spinal Cord & Nervous System --- CEREBROVASCULAR DISORDERS
Brain, Spinal Cord & Nervous System --- BRAIN DISEASES
Brain, Spinal Cord & Nervous System --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- NERVOUS SYSTEM DISEASES
Heart/Cardiovascular --- VASCULAR DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
MeSH Terms
INTRACRANIAL ANEURYSM
INTRACRANIAL ARTERIAL DISEASES
CEREBROVASCULAR DISORDERS
BRAIN DISEASES
CENTRAL NERVOUS SYSTEM DISEASES
NERVOUS SYSTEM DISEASES
ANEURYSM
VASCULAR DISEASES
CARDIOVASCULAR DISEASES