Axium Coil in Completing Endovascular Aneurysm Surgery Study

Axium Coil in Completing Endovascular Aneurysm Surgery Study: A Single-center, Prospective Observational Registry

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01194388

Acronym

ACCESS

Enrollment

Registered

2010-09-03

Start date

2010-09-30

Completion date

2012-02-29

Last updated

2021-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Aneurysm

Keywords

Patients presenting with an intracranial aneurysm

Brief 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.

Detailed 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.

Interventions

DEVICEMicroFx™ 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.

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026