Interventional Clinical Trial for CCSVI in Multiple Sclerosis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2017-08-01

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.

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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

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Catheter Venography & Balloon Venoplasty

Patients will undergo catheter venography with balloon venoplasty procedure.

Group Type ACTIVE_COMPARATOR

Catheter venography with balloon venoplasty

Intervention Type PROCEDURE

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.

Catheter venography with balloon venoplasty and balloon

Intervention Type DEVICE

Catheter Venography Only

Patients will undergo catheter venography only.

Group Type SHAM_COMPARATOR

Catheter venography with balloon venoplasty

Intervention Type PROCEDURE

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.

Interventions

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Catheter venography with balloon venoplasty

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.

Intervention Type PROCEDURE

Catheter venography with balloon venoplasty and balloon

Intervention Type DEVICE

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