CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 119 enrolled
Drug / intervention
The AXIUM Progressive Coil Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00703794
NCT00703794N/ACompleted
CompareCT.gov

ev3 Researching AXIUM Coiling Experience and Recanalization (RACER)

Medtronic Neurovascular Clinical Affairs·observational·Posted Jun 24, 2008·Updated Oct 29, 2018

In Brief

An observational study evaluating The AXIUM Progressive Coil System for Aneurysms and 3 related conditions. Completed, enrolled 119 participants across 18 sites.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAneurysms, Vascular Diseases, Cerebrovascular Disorders, Intracranial Arterial Diseases
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 24, 2008
Enrollment StartJun 1, 2008
Primary CompletionJan 16, 2012
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 18.0 years ago

Interventions

The AXIUM Progressive Coil Systemdevice

Embolization of aneurysm