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 — DEVICE
    Venography followed by therapeutic balloon angioplasty
  • Control arm — OTHER
    Venography 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 arm
    Venography and sham angioplasty
  • Active Comparator: Active arm
    therapeutic balloon angioplasty

Primary Outcome Measure

Percentage of Patients With Immediate and Short-term SAE [ Time Frame: 24 hours-1 month ]

Locations (1)

FacilityCityStateZIPSite coordinators
University at Buffalo NeurosurgeryBuffaloNew York14209-

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