Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE

University at Buffalo (UB)

Status

Completed

Conditions

Multiple Sclerosis

Treatments

Other: Control arm

Device: Selective Venography followed by therapeutic balloon angioplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT01450072

NSG1730210B

Details and patient eligibility

About

The Departments of Neurology and Neurosurgery are conducting this research study to evaluate the safety and effectiveness of intravascular angioplasty for the treatment of venous narrowing in the treatment of Multiple Sclerosis (MS).

Enrollment

20 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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