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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by ev3.
Recruitment status was:  Recruiting
University of Florida
Information provided by (Responsible Party):
ev3 Identifier:
First received: March 23, 2011
Last updated: March 8, 2012
Last verified: June 2011
Ten study centers from US are anticipated to participate for this evaluation. Published literature on coils with electrolytic, thermal or hydraulic detachment will serve as the basis for control comparisons to the Axium™ MicroFX™ Detachable Coil System for patients undergoing embolization of intracranial aneurysm. Comparison will be based on criteria evaluating the safety of the procedure, the reliability of detachment, the occlusion stability and the packing density impact

Condition Intervention
Aneurysm Device: Axium™ MicroFX™ PGLA COILS

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by ev3:

Estimated Enrollment: 100
Study Start Date: March 2011
Groups/Cohorts Assigned Interventions
Axium™ MicroFX™ PGLA Treated Subjects
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
Device: Axium™ MicroFX™ PGLA COILS
Axium™ MicroFX™ PGLA COILS


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01323439

Contact: Nina McGrew 352-273-7935

United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
  More Information

Responsible Party: ev3 Identifier: NCT01323439     History of Changes
Other Study ID Numbers: AMERICA
Study First Received: March 23, 2011
Last Updated: March 8, 2012

Keywords provided by ev3:
Patients presenting with an intracranial aneurysm

Additional relevant MeSH terms:
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on August 16, 2017