Phase I/II Interventional Clinical Trial of Balloon Venoplasty for Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis Patients
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- University of British Columbia
- Enrollment
- 104
- Locations
- 4
- Primary Endpoint
- Adverse Events
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Anthony Traboulsee
Principal Investigator
University of British Columbia
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) or Secondary Progressive MS according to the McDonald criteria 2010
- •Age 18 to 65 years inclusive
- •Neurostatus (EDSS) score at screening from 0 to 6.5
- •Fulfill ultrasound criteria for CCSVI
Exclusion Criteria
- •Previous venoplasty and/or stenting of extra cranial venous system
Outcomes
Primary Outcomes
Adverse Events
Time Frame: 48 weeks
To investigate the safety and tolerability of balloon venoplasty compared to sham in Multiple Sclerosis (MS) patients with CCSVI as measured by adverse events occurring within 48 weeks of the procedure.
Secondary Outcomes
- Clinical Outcome(48 weeks)