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.
Do you know if they plan to do additional procedures if restenosis occurs, or if it's just one-shot chance? I don't know how they'd be able to work additional procedures in and keep it sham/blinded. So I would guess that if patients restenose, they are left that way.
I can't help but compare it to how my treatments went: first procedure covered fully under insurance except for the travel expenses to NY, and then a second procedure where restenosis was found and treated, again fully covered under insurance. Yes, I'd pick that experience over being in a clinical trial, maybe getting two years of sham, and not getting treated for restenosis if restenosis occurs. But if I had no access to the procedure and couldn't afford to self-pay, I could only hope to live in Saskatchewan and be among those randomly drawn to participate in this trial.
It does get back to the conversations we had quite a long time ago, about whether or not a randomized controlled trial of CCSVI would be ethical. I can't imagine going untreated with my bilateral high-grade jugular stenoses, especially in hindsight knowing how much better I am post-procedure. If randomized controlled trials are necessary, then they are necessary, but it is a shame that obstructions in the outflow from the brain are not an obvious condition in need of treatment.
I bet it's the two-year time frame of the study that upsets me. Dr. Dake's proposed three-month study was an easier amount of sham-time.
I second what 1eye said in support and appreciation of those who participate in this trial!