Prospective Randomized Endovascular Therapy in Multiple Sclerosis

Study Overview
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Brief Summary
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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) To study the morphology of the venous anomalies by using intraluminal ultrasound (IVUS). To evaluate preliminary efficacy of endovascular therapy (angioplasty) as measured by clinical (relapse rate, disability progression (EDSS)), sonographic (ECD/TCD) and MRI/MRV parameters. To evaluate change in patients self-reported QOL following the therapeutic angioplasty To evaluate whether changes in QOL, fatigue, MSFC or attention following therapeutic angioplasty are associated with brain changes as measured by functional MRI (fMRI).

Official Title
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Prospective Randomized Endovascular Therapy in Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Venous Angioplasty
* Other: Sham Angioplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Venous Angioplasty<br>20 patients will have venous angio plasty | Other: Venous Angioplasty<br>* venous angiogram to look for lesions or flaps and then plastying vessels open.<br>|
| Sham Comparator: Angio with no plasty<br>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<br>* Patients will be brought to the angio suite and will not know if they are having the venous angioplasty or not.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAE | Severe Adverse Events measured at 24 hours Immediate and 1 month Short term post-surgical safety outcome in MS patients diagnosed with CCSVI that underwent therapeutic angioplasty | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis