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Completed

NCT Number: NCT01323439

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

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

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Key information

Conditions

Aneurysm Cardiovascular Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Axium™ MicroFX™ PGLA COILS

Device

Axium™ MicroFX™ PGLA COILS to treat aneurysms

Primary outcomes

  1. Anatomic occlusion of the aneurysm

    Time frame: Immediately post-procedure

    Occlusion of aneurysm based on the Raymond classification

Secondary outcomes

  1. Safety during the procedure

    Time frame: Discharge, up to two years

    Morbidity and mortality rate

  2. Safety post-procedure

    Time frame: 3-6 months follow-up

    Morbidity and mortality rate

  3. Detachment system performance

    Time frame: During procedure

    Occurrence of detachment failure

  4. Stability of embolization

    Time frame: 3-6 months follow-up

    Rate of change towards worsening Raymond grades

  5. Packing efficacy

    Time frame: 36- months follow-up

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

Sponsors and collaborators

Lead sponsor

Medtronic Neurovascular Clinical Affairs

Industry

Collaborators

  • University of Florida

Registry information

Acronym: AMERICA

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 25, 2011
Registry last updated
Aug 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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