Researching AXIUM Coiling Experience and Recanalization (RACER) (RACER)
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|ClinicalTrials.gov Identifier: NCT00703794|
Recruitment Status : Completed
First Posted : June 24, 2008
Last Update Posted : October 29, 2018
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 or disease||Intervention/treatment|
|Aneurysms Vascular Diseases Cerebrovascular Disorders Intracranial Arterial Diseases||Device: The AXIUM Progressive Coil System|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||119 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||ev3 Researching AXIUM Coiling Experience and Recanalization (RACER)|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||January 16, 2012|
|Actual Study Completion Date :||January 16, 2012|
Device: The AXIUM Progressive Coil System
Embolization of aneurysm
- Percent Occlusion [ Time Frame: Defined in protocol ]
- Morbidity/Mortality [ Time Frame: Defined in protocol ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00703794
|Principal Investigator:||Ajay K Wakhloo, MD, PhD||University of Massachusetts, Worcester|