Prospective Randomized Endovascular Therapy in Multiple Sclerosis - 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