Multiple Sclerosis Clinical Trial
Official title:
Phase I/II Interventional Clinical Trial of Balloon Venoplasty for Chronic Cerebrospinal Venous Insufficiency 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
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