Axium™ MicroFX™ for Endovascular Repair of IntraCranial Aneurysm-A Multicenter Study



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 90
Updated:4/2/2016
Start Date:March 2011
Contact:Nina McGrew
Phone:352-273-7935

Use our guide to learn which trials are right for you!

Trial Summary
Trial Overview
Inclusion Criteria

Ten study centers from US are anticipated to participate for this evaluation. Published
literature on coils with electrolytic, thermal or hydraulic detachment will serve as the
basis for control comparisons to the Axium™ MicroFX™ Detachable Coil System for patients
undergoing embolization of intracranial aneurysm. Comparison will be based on criteria
evaluating the safety of the procedure, the reliability of detachment, the occlusion
stability and the packing density impact


Inclusion Criteria:

- 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 Criteria:

- 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.
We found this trial at
1
site
University of Florida
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
?
mi
from
Gainesville, FL
Click here to add this to my saved trials