Overview

This trial is active, not recruiting.

Condition intracranial aneurysm
Treatment microfx™ pgla coils
Sponsor ev3
Start date September 2010
End date December 2011
Trial size 25 participants
Trial identifier NCT01194388, ACCESS-09012010

Summary

The current observational evaluation is designed to evaluate the performance of the Axium™ MicroFx™ Detachable Coil System for the treatment of intracranial aneurysms in the real life practice.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
microfx™ pgla coils
. This observational evaluation will evaluate early experience using the Axium™ MicroFx™ Detachable Coils as compared to published literature of coils with electrolytic, thermal or hydraulic detachment process or the Axium™ bare Detachable Coils arm obtained from previous evaluation conducted following the same protocol.

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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.

Additional Information

Official title Axium Coil in Completing Endovascular Aneurysm Surgery Study: A Single-center, Prospective Observational Registry
Description Up to 25 patients from from US centers are anticipated to be enrolled 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2010.
Information provided to ClinicalTrials.gov by ev3.