This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Collaborator:
University of Florida
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier:
NCT01323439
First received: March 23, 2011
Last updated: August 28, 2017
Last verified: August 2017
  Purpose
This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 100 aneurysms.

Condition Intervention
Aneurysm Device: Axium™ MicroFX™ PGLA COILS

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Axium™ MicroFX™ for Endovascular Repair of IntraCranial Aneurysm-A Multicenter Study

Resource links provided by NLM:


Further study details as provided by Medtronic Neurovascular Clinical Affairs:

Primary Outcome Measures:
  • Anatomic occlusion of the aneurysm [ Time Frame: Immediately post-procedure ]
    Occlusion of aneurysm based on the Raymond classification


Secondary Outcome Measures:
  • 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


Enrollment: 99
Study Start Date: April 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Device: Axium™ MicroFX™ PGLA COILS
Axium™ MicroFX™ PGLA COILS to treat aneurysms

Detailed Description:
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.
  Eligibility

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
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
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 ClinicalTrials.gov identifier: NCT01323439

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
Medtronic Neurovascular Clinical Affairs
University of Florida
  More Information

Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT01323439     History of Changes
Other Study ID Numbers: AMERICA
Study First Received: March 23, 2011
Last Updated: August 28, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Medtronic Neurovascular Clinical Affairs:
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 September 21, 2017