Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by ev3.
Recruitment status was  Recruiting
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

March 23, 2011
March 8, 2012
March 2011
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT01323439 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Axium™ MicroFX™ for Endovascular Repair of IntraCranial Aneurysm-A Multicenter Study
Not Provided

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Aneurysm
Device: Axium™ MicroFX™ PGLA COILS
Axium™ MicroFX™ PGLA COILS
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
Intervention: Device: Axium™ MicroFX™ PGLA COILS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
Not Provided

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.
Both
18 Years to 90 Years
No
Contact: Nina McGrew 352-273-7935
United States
 
NCT01323439
AMERICA
Not Provided
ev3
ev3
University of Florida
Not Provided
ev3
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP