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Researching AXIUM Coiling Experience and Recanalization (RACER)

NCT00703794 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 119

Last updated 2018-10-29

No results posted yet for this study

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.

Conditions

  • Aneurysms
  • Vascular Diseases
  • Cerebrovascular Disorders
  • Intracranial Arterial Diseases

Interventions

DEVICE

The AXIUM Progressive Coil System

Embolization of aneurysm

Sponsors & Collaborators

  • Medtronic Neurovascular Clinical Affairs

    lead INDUSTRY

Principal Investigators

  • Ajay K Wakhloo, MD, PhD · University of Massachusetts, Worcester

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2012-01-16
Completion
2012-01-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00703794 on ClinicalTrials.gov