This is a double blind clinical trial, with an arm. It is also a half treated with the real CCSVI angioplasty, and a half sham treatment. (placebo)
All must have a US Doppler or MRI/MRV proof of meeting CCSVI criteria prior.
I think they have to return for a few follow-ups unless the US Doppler will be in Canada. They required me to have a 3, 6, 9 and 12 month US Doppler in Albany, NY. I believe it could be more local if I called and could not make it for one of those visits, and consultations with the Dr.
But with a DB trial, they have to make sure that the trial co-coordinators, IR's and Neurologists get all the i's dotted and t's crossed. It takes time to set up a clinical trial, even for drugs, let alone a procedure.
There will be many QOL questionnaires. I did many now, and I was not in a trial. It is a lengthily booklet. A little on the order of how Dr Timothy Vollmer (sp?) did his 6 month questionnaires on MS. I did them for 10 years =boring. Lol You know those, "In the last 4 weeks, how was this______? type of questions.
FYI: At my first CCSVI procedure, at Albany Hospital (yes), while on the table before they started, the resident doctor asked out loud if I were the sham or true procedure? WHAT!!!!
I think she sent my bp monitor flying upward. He yelled, NO! this is a true case not part of any trial. Whew! I sure wanted some drugs after that scare, yet little drugs are given.
Where there is a will, there is a way. "HOPE"
CCSVI Procedure December 2010