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Interventional Clinical Trial for CCSVI in Multiple Sclerosis Patients

NCT01864941 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2018-04-17

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Multiple Sclerosis Society of Canada

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Anthony Traboulsee, MD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2017-08-01
Completion
2017-08-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01864941 on ClinicalTrials.gov