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Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE

CompletedNA

Sponsor: State University of New York at Buffalo

Conditions: Multiple Sclerosis

Interventions: Selective Venography followed by therapeutic balloon angioplasty, Control arm

Countries: United States

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Buffalo, New York, United States