I bet a lot of people with CCSVI are going to be pleased. This is a randomized placebo controlled trial. I'm sure there will be good blinding. If you are a Saskatchewanian who is going into this trial, be of good cheer, because a lot of people are cheering for you. I know what its like to be on placebo for 2 years. You can do it. You'll come through OK, in spite of the ravages that will be allowed to go unchecked. I don't know if they are planning to allow people to continue on DMDs, but even if they don't, DMDs are marginally (if at all) better than placebo anyway, when you aren't risking your life. I don't know what the inclusion parameters are, if they are taking PP"MS" people. If they want to reproduce Dr. Zamboni's work, they have to. I don't think there should be a washout period. That would delay things even more, and they are not testing a new drug, but a proven, safe procedure. If there are immediate results, you'll hear it argued that that was the DMD you are not on any more. The results, if they happen at all, will be obvious. Better than anything you ever got from a drug. I progressed while I was on placebo. Make sure you take care, get exercise, and follow cheerleader's program. It makes the treatment work even better.
You'll survive, you will go back on treatment, whatever that is, if the procedure doesn't work (fat chance), and you'll have the gratitude of a whole lot of Canadians. If it were me I'd be going back on nothing, no DMDs, which is what they have to offer. That's because of my SP"MS" status. I hope they run the trial on all pw"MS", and that by random chance, the number of SP and PP people who are in the placebo group is zero.
Restenosis: They will want to distinguish a treatment effect from placebo. One of the arguments is likely to be, that it wasn't restenosis, it was just placebo wearing off. I do think all should be followed after the trial ends. There are bound to be disputes when restenosis appears. I think that will be less likely as time goes by. My symptom relief lasted more than 1 year. Though I was treated 1.5 years ago, plenty of people have been treated since me, and there has been a lot of experience gained. I think by another 1.5 years, restenosis rates will be way down. For some it has lasted well, but it is still early. The use of IVUS will make things a lot better. The IRs will sort that out. JMHO.
"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'MS' is over - if you want it
Patients sans/without patience
I am not a doctor. Do not take anything I say as medical advice.