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CCSVI Study by Center for Vascular, Albany, NY – 500 Persons

Last modified: 01.04.2010 - 20:52 CET Created: 01.04.2010 - simplex

Study to evaluate treating chronic cerebrospinal venous insufficiency (CCSVI) in multiple sclerosis patients. 500 persons are enrolled.

[prep_mehta10a]

Mehta M: Liberation Study. clinicaltrials.gov: NCT01089686. v-aware Vol. 2, Issue 1, March 2010, p18: Announcement.
The Vascular Group, PLLC, Albany NY.
Description
Primary Outcome Measures:
  • Incidence of major adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    The evaluation of safety will be defined as the incidence of major adverse events at 30 days following the index procedure. The evaluation of feasibility and efficacy will be determined by those patients that do not have more than 50 percent restenosis within the 30 day time frame.
Secondary Outcome Measures:
  • Mortality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Secondary endpoints will be evaluated with all subjects based upon mortality, incidence of all secondary interventions and incidence of all major adverse events for a period of 2 years.
Estimated Enrollment: 500
Study Start Date: April 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
  • Procedure: Angioplasty
    To identify the presence of CCSVI, all patients will undergo a clinical evaluation by a neurologist, a duplex ultrasound of central extracranial venous system, an MRV, and a venogram. The decision to enroll patient in percutaneous angioplasty for CCSVI will be made at the time of venogram, in select patients that have greater than or equal to 50 percent stenosis of the extracranial central veins including the internal jugular veins and the azygos vein. Extracranial venous ultrasound will be performed at 3, 6, 12, 18, and 24 months following the procedure or if clinical symptoms recur. MRV and venograms will be performed at 12months and 24 months or if clinical symptoms recur.
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