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Researching AXIUM Coiling Experience and Recanalization (RACER) (RACER)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00703794
First Posted: June 24, 2008
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs
  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
Aneurysms Vascular Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Device: The AXIUM Progressive Coil System

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: ev3 Researching AXIUM Coiling Experience and Recanalization (RACER)

Further study details as provided by Medtronic Neurovascular Clinical Affairs:

Primary Outcome Measures:
  • Percent Occlusion [ Time Frame: Defined in protocol ]

Secondary Outcome Measures:
  • Morbidity/Mortality [ Time Frame: Defined in protocol ]

Enrollment: 119
Study Start Date: June 2008
Study Completion Date: December 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
AXIUM Coils Device: The AXIUM Progressive Coil System
Embolization of aneurysm

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with intracranial aneurysm, either ruptured or un-ruptured, with aneurysm has a maximum diameter of 2mm to 20mm
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
Information from the National Library of Medicine

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


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
Medtronic Neurovascular Clinical Affairs
Investigators
Principal Investigator: Ajay K Wakhloo, MD, PhD University of Massachusetts, Worcester
  More Information

Additional Information:
Publications:
Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT00703794     History of Changes
Other Study ID Numbers: ev3-FD1942-CR00045
First Submitted: June 23, 2008
First Posted: June 24, 2008
Last Update Posted: September 29, 2017
Last Verified: September 2017

Keywords provided by Medtronic Neurovascular Clinical Affairs:
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

Additional relevant MeSH terms:
Aneurysm
Vascular Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases