Multi-center Registry for CCSVI Testing and Treatment (CCSVI)

September 15, 2012 updated by: Hubbard Foundation
Patients suspected of CCSVI (chronic cerebrospinal venous insufficiency) may be tested and if appropriate treated with catheter venoplasty by an interventional radiologist in their local community who has been credentialled either by the local hospital's IRB or a national IRB if the procedure is done in an outpatient facility. Catheter angioplasty is a long-established and accepted medical procedure, patients' insurance should but may not cover the testing or treatment.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

more to follow

Study Type

Observational

Enrollment (Anticipated)

1000

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
      • Downey, California, United States, 90241
        • Vascular Access Center of Downey
      • Oceanside, California, United States, 92056
        • North County Radiology
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Vascular Access Care of Atlanta
    • New York
      • New York, New York, United States, 10022
        • Columbia endovascular Associates
      • Poughkeepsie, New York, United States, 12601
        • Valley Endovascular Associates
    • Ohio
      • Dayton, Ohio, United States, 45409
        • Dayton Interventional Radiology
    • Utah
      • Provo, Utah, United States, 84604
        • Utah Valley Interventional Associates
      • Salt Lake City, Utah, United States, 84107
        • Utah Vascular Clinic
    • Washington
      • Seattle, Washington, United States, 14220
        • Vascular Access Center of Seattle

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

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients suspected of obstructions in the veins draining the central nervous system which may adversely affect CNS function

Description

Inclusion Criteria:

Referral by patients primary treating physician for suspected CCSVI

Exclusion Criteria:

Abnormal kidney function Allergy to either or both of the imaging contrast agents Pacemaker or other implantable device Ferrous metal in or on the body Claustrophobia Pregnancy

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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

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CNS draining vein abnormalities
Procedure: venous angioplasty
catheter venous angioplasty via femoral vein approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Short-Form 36 (SF36) Quality of Life Instrument
Time Frame: Baseline and at 1, 6 and 12 months after treatment
Baseline and at 1, 6 and 12 months after treatment

Collaborators and Investigators

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

Sponsor

Hubbard Foundation

Investigators

  • Study Chair: David R Hubbard, M.D., Hubbard Foundation

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.

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

September 1, 2010

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

September 17, 2010

First Submitted That Met QC Criteria

September 17, 2010

First Posted (Estimate)

September 20, 2010

Study Record Updates

Last Update Posted (Estimate)

September 18, 2012

Last Update Submitted That Met QC Criteria

September 15, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCSVI Registry

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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