We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov Menu
Trial record 1 of 19 for:    Ccsvi
Previous Study | Return to List | Next Study

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

This study has suspended participant recruitment.
(9/12/12 FDA stopped enrollment pending device exemption(IDE)application.)
ClinicalTrials.gov Identifier:
First Posted: September 20, 2010
Last Update Posted: September 18, 2012
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.
Information provided by (Responsible Party):
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.

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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Multi-center Registry for CCSVI Testing and Treatment

Resource links provided by NLM:

Further study details as provided by Hubbard Foundation:

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

Estimated Enrollment: 1000
Study Start Date: September 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CNS draining vein abnormalities Procedure: venous angioplasty
catheter venous angioplasty via femoral vein approach

Detailed Description:
more to follow

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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
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 Submitted: September 17, 2010
First Posted: September 20, 2010
Last Update Posted: September 18, 2012
Last Verified: September 2012

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

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