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MS-CCSVI Phase I/II Treatment Trial
The Djavad Mowafaghian Centre for Brain Health MS Clinic and the UBC Hospital Interventional Radiology Centre have lead a national CCSVI treatment trial called Phase I/II Interventional Clinical Trial of Balloon Venoplasty for CCSVI (Chronic Cerebrospinal Venous Insufficiency) in Multiple Sclerosis patients.
- The phase I/II treatment trial funded by the Canadian Institutes of Health Research (CIHR), The MS Society of Canada, the Michael Smith Foundation for Health Research, the Provinces of Manitoba and Quebec involved four Canadian centres (Vancouver, Winnipeg, Montreal and Quebec City). 104 MS patients participated in this blinded sham controlled trial to determine if venoplasty improves MS symptoms and is safe.
- Results after participants completed one year of follow up were presented by Dr. L. Machan (Interventional Radiologist, UBC) at the Society for Interventional Radiology annual meeting in Washington, DC, on March 8, 2017.
About the trial
- This study is multidisciplinary involving neurologists, vascular radiologists, MRI specialists, cardiologists and ethicists.
- Stringent safety protocols are in place, including an independent data safety monitory board, which would look at the ethics of continuing the study if it were not in the best interests of patients.
- The goals of the trial are to determine the safety and efficacy of treating CCSVI as an MS strategy. It will also focus on the impact on quality of life and routinely used clinical and MRI outcomes.
- Participants were randomized to receive balloon venoplasty intervention or a sham intervention and cross over to the other intervention at year one, so all patients will receive the venoplasty at some point.
- The venography, sham and venoplasty procedures underwent stringent standardization and training to ensure uniformity across the 4 centers.
- Participants, physicians, and nurses were blinded to the intervention throughout the study.