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

NCT01323439 | Completed FDA Device

• 1 other identifier: AMERICA
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aneurysm

Keywords

Patients presenting with an intracranial aneurysm

Outcome Measures

Primary Outcomes (1)

• Anatomic occlusion of the aneurysm

  Occlusion of aneurysm based on the Raymond classification

  Immediately post-procedure

Secondary Outcomes (5)

• Safety during the procedure

  Discharge, up to two years

• Safety post-procedure

  3-6 months follow-up

• Detachment system performance

  During procedure

• Stability of embolization

  3-6 months follow-up

• Packing efficacy

  36- months follow-up

Study Arms (1)

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

Interventions

Axium™ MicroFX™ PGLA COILS DEVICE

Axium™ MicroFX™ PGLA COILS to treat aneurysms

Axium™ MicroFX™ PGLA Treated Subjects

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Neurovascular Clinical Affairs: lead
• University of Florida: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 25, 2011
• Study Start: April 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: August 30, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)