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

Medtronic

Status: Completed

Conditions: Aneurysm

Treatments: Device: Axium™ MicroFX™ PGLA COILS

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01323439

AMERICA

Details and patient eligibility

About

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

Full description

This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 99 patients at 13 study centers. The primary endpoint of the trial was the anatomic occlusion of the aneurysm in the immediate post-procedure angiogram basedon the Raymond classification. Secondary endpoints included safety during the procedure, safety after the procedure, detachment system performance, stability of the embolization, and packing efficacy.

Enrollment: 99 patients

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

99 participants in 1 patient group

Axium™ MicroFX™ PGLA Treated Subjects

Description:

This observational evaluation will evaluate early experience using the Axium™ MicroFX™ PGLA 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

Treatment:

Device: Axium™ MicroFX™ PGLA COILS