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Axium Coil in Completing Endovascular Aneurysm Surgery Study (ACCESS)

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 September 2010 by ev3.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01194388
First Posted: September 3, 2010
Last Update Posted: September 3, 2010
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.
Information provided by:
ev3
September 1, 2010
September 3, 2010
September 3, 2010
September 2010
December 2011   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
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Axium Coil in Completing Endovascular Aneurysm Surgery Study
Axium Coil in Completing Endovascular Aneurysm Surgery Study: A Single-center, Prospective Observational Registry
The current observational evaluation is designed to evaluate the performance of the Axium™ MicroFx™ Detachable Coil System for the treatment of intracranial aneurysms in the real life practice.
Up to 25 patients from from US centers are anticipated to be enrolled 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.
Observational
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.
Intracranial Aneurysm
Device: MicroFx™ PGLA COILS
. 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.
MicroFx™ PGLA Treated Subjects
Intervention: Device: 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.
 
Unknown status
25
Not Provided
December 2011   (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
 
 
NCT01194388
ACCESS-09012010
No
Not Provided
Not Provided
Linda Simpson, ev3 Endovascular
ev3
Not Provided
Not Provided
ev3
September 2010