Trial record 1 of 13 for:    Ccsvi
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Multi-center Registry for CCSVI Testing and Treatment

This study has suspended participant recruitment.
(9/12/12 FDA stopped enrollment pending device exemption(IDE)application.)
Sponsor:
Information provided by (Responsible Party):
Hubbard Foundation
ClinicalTrials.gov Identifier:
NCT01205633
First received: September 17, 2010
Last updated: September 15, 2012
Last verified: September 2012
  Purpose

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Hubbard Foundation
ClinicalTrials.gov Identifier: NCT01205633     History of Changes
Other Study ID Numbers: CCSVI Registry
Study First Received: September 17, 2010
Last Updated: September 15, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 24, 2014