Axium Coil in Completing Endovascular Aneurysm Surgery Study (ACCESS)

Medtronic

Status: Withdrawn

Conditions: Intracranial Aneurysm

Treatments: Device: MicroFx™ PGLA COILS

Study type: Observational

Funder types: Industry

Identifiers

NCT01194388

ACCESS-09012010

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 1 patient group

MicroFx™ PGLA Treated Subjects

Treatment:

Device: MicroFx™ PGLA COILS