Researching AXIUM Coiling Experience and Recanalization (RACER)

Medtronic

Status: Completed

Conditions: Vascular Diseases; Cerebrovascular Disorders; Intracranial Arterial Diseases; Aneurysms

Treatments: Device: The AXIUM Progressive Coil System

Study type: Observational

Funder types: Industry

Identifiers

NCT00703794

ev3-FD1942-CR00045

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

119 participants in 1 patient group

AXIUM Coils

Treatment:

Device: The AXIUM Progressive Coil System