Researching AXIUM Coiling Experience and Recanalization (RACER) (RACER)

October 26, 2018 updated by: Medtronic Neurovascular Clinical Affairs

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

119

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90089
        • Lac+Usc/Uscuh
      • Orange, California, United States, 92868
        • Vascular and Interventional Specialists of Orange County, Inc. - St. Joseph Hospital of Orange
    • Florida
      • Fort Myers, Florida, United States, 33908
        • Lee Memorial Health System
      • Miami, Florida, United States, 33136
        • University of Miami - Jackson Memorial Hospital Systems
      • Saint Petersburg, Florida, United States, 33701
        • Bayfront Medical Center
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Neurologic & Orthopedic Hospital of Chicago (NOHC)
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern
    • New York
      • Buffalo, New York, United States, 14209
        • Kaleida Health - Millard Fillmore
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University (OHSU)
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina (MUSC)
      • Columbia, South Carolina, United States, 29203
        • Palmetto Richland Health Memorial Hospital
    • Vermont
      • Burlington, Vermont, United States, 05401-1473
        • Fletcher Allen Health Care
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with intracranial aneurysm, either ruptured or un-ruptured, with aneurysm has a maximum diameter of 2mm to 20mm

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AXIUM Coils
Device: The AXIUM Progressive Coil System
Embolization of aneurysm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Occlusion
Time Frame: Defined in protocol
Defined in protocol

Secondary Outcome Measures

Outcome Measure
Time Frame
Morbidity/Mortality
Time Frame: Defined in protocol
Defined in protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Neurovascular Clinical Affairs

Investigators

  • Principal Investigator: Ajay K Wakhloo, MD, PhD, University of Massachusetts, Worcester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

January 16, 2012

Study Completion (Actual)

January 16, 2012

Study Registration Dates

First Submitted

June 23, 2008

First Submitted That Met QC Criteria

June 23, 2008

First Posted (Estimate)

June 24, 2008

Study Record Updates

Last Update Posted (Actual)

October 29, 2018

Last Update Submitted That Met QC Criteria

October 26, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ev3-FD1942-CR00045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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