Axium Coil in Completing Endovascular Aneurysm Surgery Study (ACCESS)
Recruitment status was Active, not recruiting
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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 |
| 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 |
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.
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 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 May 19, 2013