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

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

Study Overview

• Status: Completed
• Conditions: Aneurysm
• Intervention / Treatment: Device: Axium™ MicroFX™ PGLA COILS

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 99

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients presenting with an intracranial aneurysm will be evaluated by the neuro interventional team, in accordance with institutional practice, to establish an appropriate treatment plan based on the patient's medical condition and available diagnostic screening prior to recruitment

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Axium™ MicroFX™ PGLA Treated Subjects; 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	Device: Axium™ MicroFX™ PGLA COILS; Axium™ MicroFX™ PGLA COILS to treat aneurysms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomic occlusion of the aneurysm	Occlusion of aneurysm based on the Raymond classification	Immediately post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety during the procedure	Morbidity and mortality rate	Discharge, up to two years
Safety post-procedure	Morbidity and mortality rate	3-6 months follow-up
Detachment system performance	Occurrence of detachment failure	During procedure
Stability of embolization	Rate of change towards worsening Raymond grades	3-6 months follow-up
Packing efficacy	increase in packing density calculated as ration between volume of coils and the aneurysm volume	36- months follow-up

Collaborators and Investigators

• Sponsor: Medtronic Neurovascular Clinical Affairs
• Collaborators: University of Florida

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: March 23, 2011
• First Submitted That Met QC Criteria: March 24, 2011
• First Posted (Estimate): March 25, 2011

Study Record Updates

• Last Update Posted (Actual): August 30, 2017
• Last Update Submitted That Met QC Criteria: August 28, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Patients presenting with an intracranial aneurysm
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: AMERICA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No