Researching AXIUM Coiling Experience and Recanalization (RACER)
This study has been completed.
Sponsor:
ev3
Information provided by (Responsible Party):
ev3
ClinicalTrials.gov Identifier:
NCT00703794
First received: June 23, 2008
Last updated: March 8, 2012
Last verified: June 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The data collected in this study will be used to support International Regulatory submissions. The study objective is to evaluate the continued safety and efficacy of the AXIUM Progressive Coil System.
This Device has been used clinically at approximately 150 Institutions under FDA 510(k) clearance since April 24, 2007. The device received CE authorization on June 30, 2007. Through December 2007, more than 1000 patients have been treated with the AXIUM Coils.
| Condition | Intervention | Phase |
|---|---|---|
|
Aneurysms Vascular Diseases Cerebrovascular Disorders Intracranial Arterial Diseases |
Device: The AXIUM Progressive Coil System |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | ev3 Researching AXIUM Coiling Experience and Recanalization (RACER) |
Resource links provided by NLM:
Further study details as provided by ev3:
Primary Outcome Measures:
- Percent Occlusion [ Time Frame: Defined in protocol ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Morbidity/Mortality [ Time Frame: Defined in protocol ] [ Designated as safety issue: Yes ]
| Enrollment: | 119 |
| Study Start Date: | June 2008 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: AXIUM Coils |
Device: The AXIUM Progressive Coil System
Embolization of aneurysm
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient or patient's legally authorized representative has signed and dated an Informed Consent Form
- Must be at least 18 years of age
- Aneurysm location, angio-architecture, morphology, or medical condition, is considered by the neurosurgical / interventional team to be at very high risk for management by traditional operative techniques, or aneurysm is considered to be inoperable
- Patient is willing to conduct follow-up visits
Exclusion Criteria:
- Aneurysm was previously treated
- Patient has a cerebral aneurysm with a location, angioarchitecture or morphology that presents an unacceptable risk of morbidity due to the Study procedures
- Patient is participating in another clinical research Study
- Patient has a medical, social or psychological condition, which precludes the patient from receiving Study required treatment, evaluation, procedures and follow-up
- Female patient is pregnant or breast-feeding
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703794
Locations
| United States, California | |
| Lac+Usc/Uscuh | |
| Los Angeles, California, United States, 90089 | |
| Vascular and Interventional Specialists of Orange County, Inc. - St. Joseph Hospital of Orange | |
| Orange, California, United States, 92868 | |
| United States, Florida | |
| Lee Memorial Health System | |
| Fort Myers, Florida, United States, 33908 | |
| University of Miami - Jackson Memorial Hospital Systems | |
| Miami, Florida, United States, 33136 | |
| Bayfront Medical Center | |
| Saint Petersburg, Florida, United States, 33701 | |
| Tampa General Hospital | |
| Tampa, Florida, United States, 33606 | |
| United States, Illinois | |
| Neurologic & Orthopedic Hospital of Chicago (NOHC) | |
| Chicago, Illinois, United States, 60640 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| University of Massachusetts Medical Center | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Minnesota | |
| Abbott Northwestern | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, New York | |
| Kaleida Health - Millard Fillmore | |
| Buffalo, New York, United States, 14209 | |
| United States, Ohio | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oregon | |
| Oregon Health & Science University (OHSU) | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, South Carolina | |
| Medical University of South Carolina (MUSC) | |
| Charleston, South Carolina, United States, 29425 | |
| Palmetto Richland Health Memorial Hospital | |
| Columbia, South Carolina, United States, 29203 | |
| United States, Vermont | |
| Fletcher Allen Health Care | |
| Burlington, Vermont, United States, 05401-1473 | |
| United States, Wisconsin | |
| University of Wisconsin | |
| Madison, Wisconsin, United States, 53792 | |
Sponsors and Collaborators
ev3
Investigators
| Principal Investigator: | Ajay K Wakhloo, MD, PhD | University of Massachusetts, Worcester |
More Information
Additional Information:
Publications:
| Responsible Party: | ev3 |
| ClinicalTrials.gov Identifier: | NCT00703794 History of Changes |
| Other Study ID Numbers: | ev3-FD1942-CR00045 |
| Study First Received: | June 23, 2008 |
| Last Updated: | March 8, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by ev3:
|
aneurysms endovascular neurovascular therapies ev3 Neurovascular cerebrovascular RACER AXIUM |
The AXIUM Progressive Coil System ev3 MTI Micro Therapeutics FX detachable coil system K060747 brain diseases |
Additional relevant MeSH terms:
|
Aneurysm Cerebrovascular Disorders Vascular Diseases Intracranial Arterial Diseases |
Cardiovascular Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013