Axium Coil in Completing Endovascular Aneurysm Surgery Study (ACCESS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by ev3.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
ev3
ClinicalTrials.gov Identifier:
NCT01194388
First received: September 1, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Intracranial Aneurysm
Device: MicroFx™ PGLA COILS

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Axium Coil in Completing Endovascular Aneurysm Surgery Study: A Single-center, Prospective Observational Registry

Resource links provided by NLM:


Further study details as provided by ev3:

Estimated Enrollment: 25
Study Start Date: September 2010
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
MicroFx™ PGLA Treated Subjects 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.

Detailed Description:

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.

  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
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: NCT01194388

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

No publications provided

Responsible Party: Linda Simpson, ev3 Endovascular
ClinicalTrials.gov Identifier: NCT01194388     History of Changes
Other Study ID Numbers: ACCESS-09012010
Study First Received: September 1, 2010
Last Updated: September 1, 2010
Health Authority: United States: Institutional Review Board

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 August 18, 2014