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

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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):
Hubbard Foundation

Tracking Information
First Submitted Date September 17, 2010
First Posted Date September 20, 2010
Last Update Posted Date September 18, 2012
Study Start Date September 2010
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 1, 2012)
Short-Form 36 (SF36) Quality of Life Instrument [ Time Frame: Baseline and at 1, 6 and 12 months after treatment ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01205633 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Multi-center Registry for CCSVI Testing and Treatment
Official Title Multi-center Registry for CCSVI Testing and Treatment
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.
Detailed Description more to follow
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • CCSVI
  • Chronic Cerebrospinal Venous Insufficiency
  • Venous Malformations of CNS Draining Veins
Intervention Procedure: venous angioplasty
catheter venous angioplasty via femoral vein approach
Study Groups/Cohorts CNS draining vein abnormalities
Intervention: Procedure: venous angioplasty
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Suspended
Estimated Enrollment
 (submitted: September 17, 2010)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2015
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility 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

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Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01205633
Other Study ID Numbers CCSVI Registry
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hubbard Foundation
Study Sponsor Hubbard Foundation
Collaborators Not Provided
Investigators
Study Chair: David R Hubbard, M.D. Hubbard Foundation
PRS Account Hubbard Foundation
Verification Date September 2012