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Researching AXIUM Coiling Experience and Recanalization (RACER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ev3
ClinicalTrials.gov Identifier:
NCT00703794
First received: June 23, 2008
Last updated: March 8, 2012
Last verified: June 2011
History of Changes

June 23, 2008
March 8, 2012
June 2008
July 2010   (final data collection date for primary outcome measure)
Percent Occlusion [ Time Frame: Defined in protocol ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00703794 on ClinicalTrials.gov Archive Site
Morbidity/Mortality [ Time Frame: Defined in protocol ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Researching AXIUM Coiling Experience and Recanalization (RACER)
ev3 Researching AXIUM Coiling Experience and Recanalization (RACER)

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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aneurysms
  • Vascular Diseases
  • Cerebrovascular Disorders
  • Intracranial Arterial Diseases
Device: The AXIUM Progressive Coil System
Embolization of aneurysm
Experimental: AXIUM Coils
Intervention: Device: The AXIUM Progressive Coil System

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
December 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00703794
ev3-FD1942-CR00045
Yes
ev3
ev3
Not Provided
Principal Investigator: Ajay K Wakhloo, MD, PhD University of Massachusetts, Worcester
ev3
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP