Multi-center Registry for CCSVI Testing and Treatment
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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 |
- 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 |
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| 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 | |
| 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 May 16, 2013