Clinical Trial Details

NCT ID: NCT01323439
Date Last Changed: March 8, 2012

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

Recruitment Details

Gender
Both Male and Female
Age
18 to 90 Years
Overall Status
Recruiting
Lead Sponsor
ev3
Duration
Facility Type
N/A
Compensation

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

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