Interventional Clinical Trial for CCSVI in Multiple Sclerosis Patients

University of British Columbia104 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

104

Conditions

Multiple Sclerosis

Interventions

Catheter venography with balloon venoplastyPROCEDURE

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 balloonDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (4)

Vancouver Coastal Health - University of British Columbia Hospital

Vancouver, British Columbia, Canada

University of Manitoba Health Sciences Centre

Winnipeg, Manitoba, Canada

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

CHU de Québec - Hôpital de l'Enfant-Jésus

Québec, Quebec, Canada

Outcomes

Primary Outcomes

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.

Time frame: 48 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 48 weeks

Clinical Outcome

To evaluate the efficacy of balloon venoplasty compared to sham as reflected by MRI 48 weeks after the procedure.

Time frame: 48 weeks

Clinical Outcome

To evaluate the efficacy of balloon venoplasty compared to sham as reflected by catheter venography 48 weeks after the procedure.

Time frame: 48 weeks

Data from ClinicalTrials.gov

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