ThisIsMA wrote:My apologies if this question has already been asked.
My understanding is that balloon angioplasty is a technique that has been used for decades to expand arteries and veins in many other areas of the body.
In the past, as each new location within the body for using balloon angioplasty to treat a condition was begun, were clinical trials required? Was IRB approval required? Were doctors initially prevented from doing the procedure at a new anatomical location?
Or is this a unique process that is happening with CCSVI and MS?
I have been asking this same question, and have not gotten a good response yet. I supose the hospital administrator or whoever gives permission to do a particular procedure (Not all hospitals allow their doctors to do all procedures depending on abilities and equipment and the like). If the procedure had no known benefit, I supose the adminstrator could forbid doctors at that hospital from doing that procedure (I suspect this is what hapended at Stanford). Totally new procedures or experimantal procedures go through the IRB I think.
Angioplasty is a very safe procedure. New uses for an accepted and safe procedure should not be a big problem. Inadequate circulation in the brain is something that it seems to me should be releived if we know how.
Somehow because it has become associated with treating MS we are angsting over it.
We need to do studies to get information, but we should also offer the angioplasty to people with CCSVI if they are not participating in a study.
a doctor can treat someone with a standard technique for a new indication. HE CANNOT TREAT A GROUP without IRB.
BUt again I say that while this procedure is safe in the hands of competent people, the identification of stenoses, valve problems etc, is most difficult and requires practice, training or both.
I strongly believe that as Centers open under IRB oversite, they should be used for these treatments. More concentrated experience will provide better care to paients while teaching these techniques to the next generation of practicioners.
There are many trials that need to be done
1. how many veins need to be angioplastied
2. which signs and symptoms of MS and CCSVI will repsond to venoplasty
3. stents versus no stents
4. type of stent
5. RRMS versus SPMS versus PPMS. which does it work on?
6 Role of IVUS, Doppler, MRv, catheter venogram
7 how to reduce incidence of restenosis
8 how to reduce incidence of restenosis after stenting
9. Are MS drugs necessary after liberation
10. . what about treating stenoses in patients with no MS
11. many more,
geez, i just gave away my research career