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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Intracranial Arterial Diseases
Vascular Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 20, 2014