Status:
WITHDRAWN
Axium Coil in Completing Endovascular Aneurysm Surgery Study
Lead Sponsor:
Medtronic Neurovascular Clinical Affairs
Conditions:
Intracranial Aneurysm
Eligibility:
All Genders
18-90 years
Brief Summary
The current observational evaluation is designed to evaluate the performance of the Axium™ MicroFx™ Detachable Coil System for the treatment of intracranial aneurysms in the real life practice.
Detailed Description
Up to 25 patients from from US centers are anticipated to be enrolled for this evaluation. Published literature on coils with electrolytic, thermal or hydraulic detachment will serve as the basis for ...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of one or more intracranial aneurysm, either ruptured or unruptured.
- Information on data collection provided to the patient or legally authorized representative and signed informed consent.
- Aneurysm diameter ≤10mm
- Age range of 18 - 90.
Exclusion
- Aneurysm previously treated.
- Aneurysm AVM related or dissecting.
- Participation in a clinical investigation of other aneurysm treating or related devices.
- Any condition that would preclude the conduct of protocol follow-up.
- Aneurysm anatomy that is determined inappropriate for Axium coil placement, prior to opening of an Axium coil.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01194388
Start Date
September 1 2010
End Date
February 1 2012
Last Update
May 26 2021
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32611