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

This study is currently recruiting participants.
Verified June 2011 by ev3
Sponsor:
Collaborator:
University of Florida
Information provided by (Responsible Party):
ev3
ClinicalTrials.gov Identifier:
NCT01323439
First received: March 23, 2011
Last updated: March 8, 2012
Last verified: June 2011
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01323439

Contacts
Contact: Nina McGrew 352-273-7935

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
ev3
University of Florida
  More Information

No publications provided

Responsible Party: ev3
ClinicalTrials.gov Identifier: NCT01323439     History of Changes
Other Study ID Numbers: AMERICA
Study First Received: March 23, 2011
Last Updated: March 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by ev3:
Patients presenting with an intracranial aneurysm

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 21, 2013