Interventional Clinical Trial for CCSVI in Multiple Sclerosis Patients

Study Overview
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Brief Summary
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To investigate the safety and tolerability of balloon venoplasty compared to sham in Multiple Sclerosis patients with Chronic Cerebrospinal Venous Insufficiency (CCSVI) as measured by adverse events occurring within 48 weeks of the procedure.

Detailed Description
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Overview of study objectives are: To determine the safety and tolerability of venoplasty of CCSVI in Multiple Sclerosis (MS). To determine the short term and long term impact on validated patient measures and by physician and radiologic reported MS outcomes. To determine the short term and long term recurrence rate of CCSVI for veins that have been treated with venoplasty

Official Title
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Phase I/II Interventional Clinical Trial of Balloon Venoplasty for Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis Patients

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Procedure: Catheter venography with balloon venoplasty
* Device: Catheter venography with balloon venoplasty and balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) or Secondary Progressive MS according to the McDonald criteria 2010 Age 18 to 65 years inclusive Neurostatus (EDSS) score at screening from 0 to 6.5 Fulfill ultrasound criteria for CCSVI Exclusion Criteria: Previous venoplasty and/or stenting of extra cranial venous system

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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Catheter Venography & Balloon Venoplasty<br>Patients will undergo catheter venography with balloon venoplasty procedure. | Procedure: Catheter venography with balloon venoplasty<br>* All eligible patients will undergo catheter venography with balloon venoplasty and/or sham at baseline and at week 48 (i.e. Cross over design) followed by clinical and radiologic observation for a minimum of 48 weeks after each procedure.<br>Device: Catheter venography with balloon venoplasty and balloon<br> <br> |
| Sham Comparator: Catheter Venography Only<br>Patients will undergo catheter venography only. | Procedure: Catheter venography with balloon venoplasty<br>* All eligible patients will undergo catheter venography with balloon venoplasty and/or sham at baseline and at week 48 (i.e. Cross over design) followed by clinical and radiologic observation for a minimum of 48 weeks after each procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | To investigate the safety and tolerability of balloon venoplasty compared to sham in Multiple Sclerosis (MS) patients with CCSVI as measured by adverse events occurring within 48 weeks of the procedure. | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcome | To evaluate the efficacy of balloon venoplasty compared to sham as reflected by patient reported quality of life, pain and fatigue scales 48 weeks after the procedure. | 48 weeks | 
| Clinical Outcome | To evaluate the efficacy of balloon venoplasty compared to sham as reflected by physician reported clinical scales 48 weeks after the procedure. | 48 weeks | 
| Clinical Outcome | To evaluate the efficacy of balloon venoplasty compared to sham as reflected by MRI 48 weeks after the procedure. | 48 weeks | 
| Clinical Outcome | To evaluate the efficacy of balloon venoplasty compared to sham as reflected by catheter venography 48 weeks after the procedure. | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, MS, CCSVI, Zamboni, catheter venography, balloon angioplasty