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Tuesday, September 10, 2013 3:51 PM | CCSVI Alliance Volg link

CCSVI Alliance President, Sharon Richardson, had an opportunity to speak with Dr. Gary Siskin, the lead investigator of the now cancelled clinical trial for CCSVI venoplasty, based in Albany, NY.

Dr. Gary Siskin wanted to convey that he was disappointed in this outcome, but to also clarify that he is not skeptical of the venoplasty procedure to treat CCSVI, and sincerely hopes that this important research will continue.  This ambitious trial was originally designed to enroll 200 participants, in order to have statistical significance. This study was to have had a treatment arm and a placebo-controlled sham arm.

The Saskatchewan government had committed $2.2 million to have 86 patients from the province take part in the trial.  However, it was difficult to find people with MS who met the study criteria and were willing to be part of a placebo controlled trial.  Many patients want to know that they are being treated, rather than risk an invasive venoplasty procedure without treatment.   Participants in this trial would not know whether or not they had been treated for CCSVI, and this may have made patients resistant to enrolling for participation.  Funding for and patient interest in the American patient arm of the trial was also an issue.  Because of these factors, the Albany Medical Center team decided to stop the trial.

Dr. Siskin mentioned that additional trials and registries are being considered in the United States, and it is his hope that the opportunity arises for the Albany group to participate in one of these studies.