View Clinical Trial (Medical Research Study)
Axium™ MicroFX™ for Endovascular Repair of IntraCranial Aneurysm-A Multicenter Study
| City: |
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Gainesville |
| State: |
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Florida |
| Zip Code: |
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32611 |
| Conditions: |
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Aneurysm |
| Purpose: |
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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
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| Study Summary: |
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| Criteria: |
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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.
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| NCT ID: |
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NCT01323439 |
| Primary Contact: |
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Nina McGrew
Phone: 352-273-7935
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| Backup Contact: |
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N/A |
| Location Contact: |
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Gainesville, Florida 32611
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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