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Prospective Randomized Endovascular Therapy in Multiple Sclerosis

NCT05380362 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-22

Study results available
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Summary

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).

Conditions

Interventions

OTHER

Venous Angioplasty

venous angiogram to look for lesions or flaps and then plastying vessels open.

OTHER

Sham Angioplasty

Patients will be brought to the angio suite and will not know if they are having the venous angioplasty or not.

Sponsors & Collaborators

  • Volcano Corporation

    collaborator INDUSTRY

  • University at Buffalo

    lead OTHER

Principal Investigators

  • Adnan H Siddiqui, M.D., Ph. D. · University at Buffalo Neurosurgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05380362 on ClinicalTrials.gov