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NCT Number: NCT01450072

Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE

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).

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University at Buffalo Neurosurgery

Buffalo, New York, 14209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Selective Venography followed by therapeutic balloon angioplasty

Device

Venography followed by therapeutic balloon angioplasty

Control Arm

Other

Venography and sham angioplasty

Primary outcomes

  1. Percentage of Patients With Immediate and Short-term SAE

    Time frame: 24 hours-1 month

    Percent (%) of patients with Severe Adverse Events (SAE) measured at 1 month (Short term) post-surgical safety outcome in MS patients diagnosed with CCSVI that underwent therapeutic angioplasty. The 95% confidence interval of the SAE rates for immediate and short terms will be obtained by the exact method, respectively. The immediate and short term SAE rates will be analyzed, respectively, using the Fisher's exact test.

Secondary outcomes

  1. Number of Participants With More Than 75% of Normal Outflow at 1 Year Post-angioplasty

    Time frame: 1 month, 3 months, 6 months, and 1 year post-angioplasty

    Restoration of venous outflow (more than 75% of normal outflow) as measured by the combined ECD/TCD and MRV at 1 year following the angioplasty as compared to baseline as well as compared to a parallel control group of MS patients that will undergo only selective venography without balloon angioplasty (sham-angioplasty). These comparisons will be accomplished by the hierarchical linear model which takes into account the correlation within subjects. Based on the residuals, we will check the normality assumptions by the normal quantile plot and skewness.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Acronym: PREMiSE

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Oct 12, 2011
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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