Trial record 1 of 1 for:    traboulsee ccsvi
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Interventional Clinical Trial for CCSVI in Multiple Sclerosis Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of British Columbia
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Multiple Sclerosis Society of Canada
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01864941
First received: May 13, 2013
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Procedure: Catheter venography with balloon venoplasty
Device: Catheter venography with balloon venoplasty and balloon
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase I/II Interventional Clinical Trial of Balloon Venoplasty for Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis Patients

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    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:
  • Clinical Outcome [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    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.

  • Clinical Outcome [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    To evaluate the efficacy of balloon venoplasty compared to sham as reflected by physician reported clinical scales 48 weeks after the procedure.

  • Clinical Outcome [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    To evaluate the efficacy of balloon venoplasty compared to sham as reflected by MRI 48 weeks after the procedure.

  • Clinical Outcome [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    To evaluate the efficacy of balloon venoplasty compared to sham as reflected by catheter venography 48 weeks after the procedure.


Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Catheter Venography & Balloon Venoplasty
Patients will undergo catheter venography with balloon venoplasty procedure.
Procedure: 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.
Device: Catheter venography with balloon venoplasty and balloon
Sham Comparator: Catheter Venography Only
Patients will undergo catheter venography only.
Procedure: 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.

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01864941

Contacts
Contact: Laura Harvey ccsvi@brain.ubc.ca
Contact: Jennifer Tzeng ccsvi@brain.ubc.ca

Locations
Canada, British Columbia
Vancouver Coastal Health - University of British Columbia Hospital Recruiting
Vancouver, British Columbia, Canada, V6T 2B5
Contact: Laura Harvey       ccsvi@brain.ubc.ca   
Contact: Jennifer Tzeng       ccsvi@brain.ubc.ca   
Principal Investigator: Anthony Traboulsee, FRCPC         
Canada, Manitoba
University of Manitoba Health Sciences Centre Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Contact: Nick Hall       ccsvi@hsc.mb.ca   
Contact: Barbara Stanger       ccsvi@hsc.mb.ca   
Principal Investigator: Reza Vosoughi, FRCPC         
Canada, Quebec
Centre Hospitalier de l'Université de Montréal Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Guylaine Lucier       guylaine.lucier.chum@ssss.gouv.qc.ca   
Principal Investigator: Marc Girard, FRCPC         
CHU de Québec - Hôpital de l'Enfant-Jésus Recruiting
Quebec City, Quebec, Canada, G1J 1Z4
Contact: Lucie Morel       lucie.morel.cha@ssss.gouv.qc.ca   
Principal Investigator: Francois Emond, FRCPC         
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Multiple Sclerosis Society of Canada
Investigators
Study Director: Anthony Traboulsee, MD University of British Columbia
  More Information

Additional Information:
No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01864941     History of Changes
Other Study ID Numbers: H12-01153
Study First Received: May 13, 2013
Last Updated: June 17, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Multiple Sclerosis
MS
CCSVI
Zamboni
catheter venography
balloon angioplasty

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Venous Insufficiency
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014