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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01323439
First Posted: March 25, 2011
Last Update Posted: August 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Florida
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs
March 23, 2011
March 25, 2011
August 30, 2017
April 2010
October 2012   (Final data collection date for primary outcome measure)
Anatomic occlusion of the aneurysm [ Time Frame: Immediately post-procedure ]
Occlusion of aneurysm based on the Raymond classification
Not Provided
Complete list of historical versions of study NCT01323439 on ClinicalTrials.gov Archive Site
  • Safety during the procedure [ Time Frame: Discharge, up to two years ]
    Morbidity and mortality rate
  • Safety post-procedure [ Time Frame: 3-6 months follow-up ]
    Morbidity and mortality rate
  • Detachment system performance [ Time Frame: During procedure ]
    Occurrence of detachment failure
  • Stability of embolization [ Time Frame: 3-6 months follow-up ]
    Rate of change towards worsening Raymond grades
  • Packing efficacy [ Time Frame: 36- months follow-up ]
    increase in packing density calculated as ration between volume of coils and the aneurysm volume
Not Provided
Not Provided
Not Provided
 
Axium™ MicroFX™ for Endovascular Repair of IntraCranial Aneurysm-A Multicenter Study
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.
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.
Observational
Observational Model: Other
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 to treat aneurysms
Axium™ MicroFX™ PGLA Treated Subjects
This observational evaluation will evaluate early experience using the Axium™ MicroFX™ PGLA 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.
 
Completed
99
October 2012
October 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01323439
AMERICA
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Plan to Share IPD: No
Medtronic Neurovascular Clinical Affairs
Medtronic Neurovascular Clinical Affairs
University of Florida
Not Provided
Medtronic Neurovascular Clinical Affairs
August 2017