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Home » Clinical Trials » Aneurysm

Clinical Trial Details

Overview

Research Study Summary

Patients are needed to participate in a clinical research study evaluating Axium™ MicroFX™ PGLA COILS for the treatment of Aneurysm

Purpose

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

To Learn more
Gender

Both Male and Female

Age

18 to 90 Years

Overall Status

Recruiting

Lead Sponsor

ev3

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years to 90 Years

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.

Site Locations (1)

Country State City Zip Facility and Contact
United States Florida Gainesville 32611 University of Florida

Contact

Nina McGrew
352-273-7935

NCT ID: NCT01323439

Date Last Changed: March 8, 2012

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