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Researching AXIUM Coiling Experience and Recanalization (RACER)
This study is currently recruiting participants.
Verified by ev3 Endovascular, Inc., December 2008
Sponsored by: ev3 Endovascular, Inc.
Information provided by: ev3 Endovascular, Inc.
ClinicalTrials.gov Identifier: NCT00703794
  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 IV

MedlinePlus related topics: Aneurysms Brain Diseases Vascular Diseases
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: ev3 Researching AXIUM Coiling Experience and Recanalization (RACER)

Further study details as provided by ev3 Endovascular, Inc.:

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 ]

Estimated Enrollment: 125
Study Start Date: June 2008
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
AXIUM Coils: Experimental 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

Contacts
Contact: Kathy Akagha, MPH 949-837-3700 kakagha@ev3.net

Locations
United States, California
Vascular and Interventional Specialists of Orange County, Inc. - St. Joseph Hospital of Orange Recruiting
Orange, California, United States, 92868
Contact: Doreen Robinson, RN, CCRC     714-560-4450        
Principal Investigator: Howard L. Dorne, MD            
United States, Florida
Lee Memorial Health System Recruiting
Fort Myers, Florida, United States, 33908
Contact: Katie Knutson     239-336-6800        
Principal Investigator: Eric Eskioglu, MD            
Bayfront Medical Center Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Andrea Bozeman     727-893-6040        
Principal Investigator: Nasser Razack, MD            
United States, Illinois
Neurologic & Orthopedic Hospital of Chicago (NOHC) Recruiting
Chicago, Illinois, United States, 60640
Contact: Grant Griffin     773-250-0423        
Principal Investigator: Demetrius Lopes, MD            
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Colin Gorman     617-726-9143        
Principal Investigator: Albert Yoo, MD            
University of Massachusetts Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Jill Gray     508-856-6941        
United States, New York
Kaleida Health - Millard Fillmore Recruiting
Buffalo, New York, United States, 14209
Contact: Annemarie Crumlish     716-887-5200        
Principal Investigator: Elad Levy, MD            
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Doreen Andrews-Hinders     216-445-9243        
Principal Investigator: Peter Rasmussen, MD            
United States, South Carolina
Medical University of South Carolina (MUSC) Recruiting
Charleston, South Carolina, United States, 29425
Contact: Adrian T Parker     843-792-3164        
Principal Investigator: Aquilla S Turk, DO            
United States, Vermont
Fletcher Allen Health Care Recruiting
Burlington, Vermont, United States, 05401-1473
Contact: Hollister McFadden     802-847-6845        
Principal Investigator: Grant Linnell, DO            
Sponsors and Collaborators
ev3 Endovascular, Inc.
Investigators
Principal Investigator: Ajay K Wakhloo, MD, PhD University of Massachusetts
  More Information

Cerebral Aneurysm Fact Sheet  This link exits the ClinicalTrials.gov site
ev3 Inc.  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: ev3 Neurovascular Clinical Research Manager ( ev3 Neurovascular )
Study ID Numbers: ev3-FD1942-CR00045
Study First Received: June 23, 2008
Last Updated: December 18, 2008
ClinicalTrials.gov Identifier: NCT00703794  
Health Authority: United States: Institutional Review Board

Keywords provided by ev3 Endovascular, Inc.:
ev3 Neurovascular
aneurysms
cerebrovascular
endovascular
neurovascular therapies
RACER
AXIUM
The AXIUM Progressive Coil System
ev3
MTI
Micro Therapeutics
FX detachable coil system
K060747
brain diseases

Study placed in the following topic categories:
Aneurysm
Vascular Diseases
Central Nervous System Diseases
Brain Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009