Axium Coil in Completing Endovascular Aneurysm Surgery Study

NCT01194388 | Withdrawn

• 1 other identifier: ACCESS-09012010
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Aneurysm

Keywords

Patients presenting with an intracranial aneurysm

Study Arms (1)

MicroFx™ PGLA Treated Subjects

Device: MicroFx™ PGLA COILS

Interventions

MicroFx™ PGLA COILS DEVICE

. 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.

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

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; 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: September 1, 2010
• First Posted: September 3, 2010
• Study Start: September 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: May 26, 2021

Record last verified: 2021-05

Locations

US (1)