Prospective Randomized Endovascular Therapy in Multiple Sclerosis (PREMiSe)

August 5, 2025 updated by: Adnan H. Siddiqui, University at Buffalo
  1. To assess the safety of endovascular therapy (balloon angioplasty) for venous stenoses in MS patients with CCSVI as documented by sonographic (extracranial echocolor-Doppler (ECD) and transcranial color Doppler (TCD)
  2. To study the morphology of the venous anomalies by using intraluminal ultrasound (IVUS).
  3. To evaluate preliminary efficacy of endovascular therapy (angioplasty) as measured by clinical (relapse rate, disability progression (EDSS)), sonographic (ECD/TCD) and MRI/MRV parameters.
  4. To evaluate change in patients self-reported QOL following the therapeutic angioplasty
  5. To evaluate whether changes in QOL, fatigue, MSFC or attention following therapeutic angioplasty are associated with brain changes as measured by functional MRI (fMRI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14209
        • Gates Circle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-65 years

    • EDSS 0-6.5
    • Diagnosis of relapsing MS according to the McDonald criteria (Polman et al., 2005)
    • Be on treatment with currently FDA approved disease-modifying treatments
    • Evidence of ≥2 sonographic parameters of suspicious abnormal extracranial cerebral venous outflow (see Table 1 background and 1.5 section)
    • Demonstration of venous occlusive disease on cervical MRV
    • Normal renal function: creatinine clearance level of >60:

Constant= 1.23 for men; 1.04 for women

Exclusion Criteria:

  • • Relapse, disease progression 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Venous Angioplasty
20 patients will have venous angio plasty
Other: Venous Angioplasty
venous angiogram to look for lesions or flaps and then plastying vessels open.
Sham Comparator: Angio with no plasty
Patients will be brought to the angio suite and given and angio but no plasty although patient will not be aware of which treatment they are having.
Other: Sham Angioplasty
Patients will be brought to the angio suite and will not know if they are having the venous angioplasty or not.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Immediate and Short-term SAE
Time Frame: 1 month post-procedure
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.
1 month post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University at Buffalo

Collaborators

Volcano Corporation

Investigators

  • Principal Investigator: Adnan H Siddiqui, M.D., Ph. D., University at Buffalo Neurosurgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

April 17, 2013

First Submitted That Met QC Criteria

May 17, 2022

First Posted (Actual)

May 18, 2022

Study Record Updates

Last Update Posted (Actual)

August 22, 2025

Last Update Submitted That Met QC Criteria

August 5, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREM 01
  • NSG1730210B (Other Identifier: HSIRB - SUNY Buffalo)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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