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

Medtronic Neurovascular Clinical Affairs99 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Aneurysm

Interventions

Axium™ MicroFX™ PGLA COILSDEVICE

Axium™ MicroFX™ PGLA COILS to treat aneurysms

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Anatomic occlusion of the aneurysm

Occlusion of aneurysm based on the Raymond classification

Time frame: Immediately post-procedure

Secondary Outcomes

Safety during the procedure

Morbidity and mortality rate

Time frame: Discharge, up to two years

Safety post-procedure

Morbidity and mortality rate

Time frame: 3-6 months follow-up

Detachment system performance

Occurrence of detachment failure

Time frame: During procedure

Stability of embolization

Rate of change towards worsening Raymond grades

Time frame: 3-6 months follow-up

Packing efficacy

increase in packing density calculated as ration between volume of coils and the aneurysm volume

Time frame: 36- months follow-up

Data from ClinicalTrials.gov

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