Axium Coil in Completing Endovascular Aneurysm Surgery Study
NCT ID: NCT01194388
Last Updated: 2021-05-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2010-09-30
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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MicroFx™ PGLA Treated Subjects
MicroFx™ PGLA COILS
. This observational evaluation will evaluate early experience using the Axium™ MicroFx™ Detachable Coils as compared to published literature of coils with electrolytic, thermal or hydraulic detachment process or the Axium™ bare Detachable Coils arm obtained from previous evaluation conducted following the same protocol.
Interventions
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MicroFx™ PGLA COILS
. This observational evaluation will evaluate early experience using the Axium™ MicroFx™ Detachable Coils as compared to published literature of coils with electrolytic, thermal or hydraulic detachment process or the Axium™ bare Detachable Coils arm obtained from previous evaluation conducted following the same protocol.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
90 Years
ALL
No
Sponsors
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Medtronic Neurovascular Clinical Affairs
INDUSTRY
Responsible Party
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Locations
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University of Florida
Gainesville, Florida, United States
Countries
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Other Identifiers
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ACCESS-09012010
Identifier Type: -
Identifier Source: org_study_id
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