Interventional Clinical Trial for CCSVI in Multiple Sclerosis Patients

Phase 1

Completed

• Conditions: Multiple Sclerosis
• Interventions: Procedure: Catheter venography with balloon venoplasty; Device: Catheter venography with balloon venoplasty and balloon

• Registration Number: NCT01864941
• Lead Sponsor: University of British Columbia

Brief Summary

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

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 Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-05-28
• Study First Posted: 2013-05-30
• Primary Completion: 2017-08-01
• Study Completion: 2017-08-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-12
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

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Exclusion Criteria

• Previous venoplasty and/or stenting of extra cranial venous system

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Catheter Venography & Balloon Venoplasty	Catheter venography with balloon venoplasty	Patients will undergo catheter venography with balloon venoplasty procedure.
Catheter Venography & Balloon Venoplasty	Catheter venography with balloon venoplasty and balloon	Patients will undergo catheter venography with balloon venoplasty procedure.
Catheter Venography Only	Catheter venography with balloon venoplasty	Patients will undergo catheter venography only.

Primary Outcome Measures

Name	Time	Method
Adverse Events	48 weeks	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.

Secondary Outcome Measures

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

Trial Locations

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; 🇨🇦 Quebec City, Quebec, Canada