Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE (PREMiSE)

Inclusion Criteria:

• Age 18-65 years
• EDSS 0-6.5 (0-5.5 in the phase II of the study)
• Diagnosis of relapsing MS according to the McDonald criteria (Polman et al., 2005)
• 1 relapse within the past 12 months or GAD positive lesion on an MRI within the past 3 months (only for phase II of the study)
• Be on treatment with currently FDA approved disease-modifying treatments (excluding Tysabri or steroids (within the last 30 days prior to enrollment)
• Evidence of ≥2 sonographic parameters of suspicious abnormal extracranial cerebral venous outflow (see Table 1 background and 1.5 section)
• Normal renal function: creatinine clearance level of >60

Exclusion Criteria:

• Relapse, disease progression and Tysabri and steroid treatment in the 30 days preceding study entry
• Pre-existing medical conditions known to be associated with brain pathology (e.g., neurodegenerative disorder, cerebrovascular disease, positive history of alcohol abuse, etc.)
• Severe peripheral chronic venous insufficiency
• Abnormal renal function
• Contrast allergy (anaphylaxis)
• Not accepting to undergo the endovascular treatment
• Peripheral Vascular Disease