NCT01323439CompletedNot Applicable
Axium™ MicroFX™ for Endovascular Repair of IntraCranial Aneurysm-A Multicenter Study
Medtronic Neurovascular Clinical Affairs1 site in 1 country99 target enrollmentStarted: April 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Anatomic occlusion of the aneurysm
Study Overview
Brief Summary
This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 100 aneurysms.
Detailed Description
This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 99 patients at 13 study centers. The primary endpoint of the trial was the anatomic occlusion of the aneurysm in the immediate post-procedure angiogram basedon the Raymond classification. Secondary endpoints included safety during the procedure, safety after the procedure, detachment system performance, stability of the embolization, and packing efficacy.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Anatomic occlusion of the aneurysm
Time Frame: Immediately post-procedure
Occlusion of aneurysm based on the Raymond classification
Secondary Outcomes
- Stability of embolization(3-6 months follow-up)
- Packing efficacy(36- months follow-up)
- Safety during the procedure(Discharge, up to two years)
- Safety post-procedure(3-6 months follow-up)
- Detachment system performance(During procedure)
Investigators
Study Sites (1)
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