Of course a double blind placebo controlled trial is the only way to prove once and for all if venoplasty helps MS patients but this is a very difficult and expensive study to do. We sympathize with Dr Siskin that he had difficulty recruiting subjects who might only get a sham procedure.
Our philosophy with the Registry is to continue collecting data and improving venoplasty technique under the auspices of the FDA to keep up the momentum until such a double blind placebo controlled study can be done.
Here is a very brief summary of where we stand with the FDA:
It's not funded, patients or their insurance must pay for the procedure. There are ultrasounds before and at 1 week and 1, 6 and 12 months. The FDA is also allowing only one brand of stent under clearly constrained circumstances, and requiring that patients have an EDSS score before and at 12 months. Otherwise it's pretty straightforward quality-of-life and adverse event form completions. Approximately 100 people have expressed interest in participating and a group of very experienced interventional radiologists around the country are waiting to begin ( we're not posting their names yet until they have a chance to review the final FDA requirements).