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

Completed

Conditions studied: Aneurysm

In brief

This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 100 aneurysms.

Key facts

Study ID

NCT01323439

Run by

Medtronic Neurovascular Clinical Affairs

People needed

99

Starts

2010-04-01

Expected to finish

2012-10-01

Last updated by the study team

2017-08-30

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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