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.

Completed

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Key information

Conditions

Aneurysms Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lac+Usc/Uscuh, Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The AXIUM Progressive Coil System

Device

Embolization of aneurysm

Primary outcomes

Percent Occlusion

Time frame: Defined in protocol

Secondary outcomes

Morbidity/Mortality

Time frame: Defined in protocol

Sponsors and collaborators

Lead sponsor

Medtronic Neurovascular Clinical Affairs

Industry

Registry information

Official study title

ev3 Researching AXIUM Coiling Experience and Recanalization (RACER)

Acronym: RACER

Important dates

Study start: 2008
Primary completion: 2012
Study completion: 2012
First posted: Jun 24, 2008
Registry last updated: Oct 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed