Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE
Part of paid clinical trials in Buffalo, New York.
- Sponsor
- State University of New York at Buffalo
- Study ID
- NCT01450072
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Selective Venography followed by therapeutic balloon angioplasty — DEVICEVenography followed by therapeutic balloon angioplasty
- Control arm — OTHERVenography and sham angioplasty
Study Details
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).
Key Dates
- Start date
- Jun 30, 2010
- Status verified
- Jun 2025
- Primary completion
- Dec 31, 2011
- Completion
- Dec 31, 2012
Study Design
- Enrollment
- 20 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Sham Comparator: Control armVenography and sham angioplasty
- Active Comparator: Active armtherapeutic balloon angioplasty
Primary Outcome Measure
Percentage of Patients With Immediate and Short-term SAE [ Time Frame: 24 hours-1 month ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University at Buffalo Neurosurgery | Buffalo | New York | 14209 | - |
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