Prospective Randomized Endovascular Therapy in Multiple Sclerosis

Part of paid clinical trials in Buffalo, New York.

Sponsor
University at Buffalo
Study ID
NCT05380362
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Venous Angioplasty — OTHER
    venous angiogram to look for lesions or flaps and then plastying vessels open.
  • Sham Angioplasty — OTHER
    Patients will be brought to the angio suite and will not know if they are having the venous angioplasty or not.

Study Details

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).

Key Dates

Start date
Jun 30, 2010
Status verified
Aug 2025
Primary completion
Apr 30, 2013
Completion
Apr 30, 2013

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Venous Angioplasty
    20 patients will have venous angio plasty
  • 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.

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Gates Circle HospitalBuffaloNew York14209-

Find similar trials in Buffalo, NY

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
Gates Circle Hospital· Buffalo, NY

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