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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01205633
Recruitment Status : Suspended (9/12/12 FDA stopped enrollment pending device exemption(IDE)application.)
First Posted : September 20, 2010
Last Update Posted : September 18, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
CCSVI Chronic Cerebrospinal Venous Insufficiency Venous Malformations of CNS Draining Veins Procedure: venous angioplasty

Detailed Description:
more to follow

Study Design

Study Type : Observational
Estimated Enrollment : 1000 participants
Time Perspective: Prospective
Official Title: Multi-center Registry for CCSVI Testing and Treatment
Study Start Date : September 2010
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01205633


Locations
United States, California
Vascular Access Center of Downey
Downey, California, United States, 90241
North County Radiology
Oceanside, California, United States, 92056
United States, Georgia
Vascular Access Care of Atlanta
Atlanta, Georgia, United States, 30309
United States, New York
Columbia endovascular Associates
New York, New York, United States, 10022
Valley Endovascular Associates
Poughkeepsie, New York, United States, 12601
United States, Ohio
Dayton Interventional Radiology
Dayton, Ohio, United States, 45409
United States, Utah
Utah Valley Interventional Associates
Provo, Utah, United States, 84604
Utah Vascular Clinic
Salt Lake City, Utah, United States, 84107
United States, Washington
Vascular Access Center of Seattle
Seattle, Washington, United States, 14220
Sponsors and Collaborators
Hubbard Foundation
Investigators
Study Chair: David R Hubbard, M.D. Hubbard Foundation
More Information

Additional Information:
Responsible Party: Hubbard Foundation
ClinicalTrials.gov Identifier: NCT01205633     History of Changes
Other Study ID Numbers: CCSVI Registry
First Posted: September 20, 2010    Key Record Dates
Last Update Posted: September 18, 2012
Last Verified: September 2012

Keywords provided by Hubbard Foundation:
neurodegenerative disease
neurovascular disease
fatigue
Hubbard Foundation
angioplasty

Additional relevant MeSH terms:
Congenital Abnormalities
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases