NCT05380362

Prospective Randomized Endovascular Therapy in Multiple Sclerosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University at Buffalo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

• Multiple Sclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-06-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2022-05-18
• Last updated: 2025-08-22
• Results posted: 2025-08-22

Locations

1 site across 1 country: United States