Researching AXIUM Coiling Experience and Recanalization (RACER)



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:18 - Any
Updated:10/31/2018
Start Date:June 2008
End Date:January 16, 2012

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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.


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
We found this trial at
18
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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9981 S Healthpark Dr # 465
Fort Myers, Florida 33908
239-343-5000
Lee Memorial Health System Our origins can be traced to the Fall of 1916 when...
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Fort Myers, FL
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Tampa, FL
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1313 Main Street
Buffalo, New York 14209
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Buffalo, NY
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111 Colchester Ave
Burlington, Vermont 05401
(802) 847-0000
Fletcher Allen Health Care As Vermont’s University Medical Center, we at Fletcher Allen are committed...
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Burlington, VT
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Charleston, South Carolina 29425
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Charleston, SC
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4501 North Winchester Avenue
Chicago, Illinois 60640
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Chicago, IL
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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5 Medical Park Road
Columbia, South Carolina 29203
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Columbia, SC
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2051 Marengo St
Los Angeles, California 90089
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Los Angeles, CA
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Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Madison, WI
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1611 Northwest 12th Avenue
Miami, Florida 33136
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Miami, FL
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Minneapolis, Minnesota 55407
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Minneapolis, MN
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Orange, CA
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Pittsburgh, PA
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Portland, OR
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701 6th Street South
Saint Petersburg, Florida 33701
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Saint Petersburg, FL
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Worcester, Massachusetts 01655
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Worcester, MA
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