Interventional Clinical Trial for CCSVI in Multiple Sclerosis Patients
Interventional Clinical Trial for CCSVI in Multiple Sclerosis Patients
To investigate the safety and tolerability of balloon venoplasty compared to sham in Multiple
 Sclerosis patients with Chronic Cerebrospinal Venous Insufficiency (CCSVI) as measured by
 adverse events occurring within 48 weeks of the procedure.
Overview of study objectives are:

 -  To determine the safety and tolerability of venoplasty of CCSVI in Multiple Sclerosis
 (MS).

 -  To determine the short term and long term impact on validated patient measures and by
 physician and radiologic reported MS outcomes.

 -  To determine the short term and long term recurrence rate of CCSVI for veins that have
 been treated with venoplasty
Inclusion Criteria:

 -  Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) or Secondary Progressive MS
 according to the McDonald criteria 2010

 -  Age 18 to 65 years inclusive

 -  Neurostatus (EDSS) score at screening from 0 to 6.5

 -  Fulfill ultrasound criteria for CCSVI

 Exclusion Criteria:

 -  Previous venoplasty and/or stenting of extra cranial venous system