Skip to main content
OpenTrials
Completed

NCT Number: NCT01864941

Interventional Clinical Trial for CCSVI in Multiple Sclerosis Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Vancouver Coastal Health - University of British Columbia Hospital, Vancouver, British Columbia, Canada

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Catheter venography with balloon venoplasty

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

Device

Primary outcomes

  1. Adverse Events

    Time frame: 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 outcomes

  1. Clinical Outcome

    Time frame: 48 weeks

    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.

  2. Clinical Outcome

    Time frame: 48 weeks

    To evaluate the efficacy of balloon venoplasty compared to sham as reflected by physician reported clinical scales 48 weeks after the procedure.

  3. Clinical Outcome

    Time frame: 48 weeks

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

  4. Clinical Outcome

    Time frame: 48 weeks

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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Multiple Sclerosis Society of Canada

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
May 30, 2013
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.