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

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

sites

Massachusetts General Hospital

185 Cambridge Street
Boston, Massachusetts 02114

617-724-5200