What is the MOBILE Trial?

VBT is currently the standard of care for treating in-stent restenosis in the coronary (heart) arteries based on the results of several clinical trials. These trials have demonstrated a significant reduction in the need for additional interventional procedures when VBT is used following angioplasty or other procedures to re-open the area of in-stent restenosis. In addition, several studies using VBT to treat narrowing of the arteries in the leg show significant reduction in the occurrence of restenosis, but further clinical trials are necessary in order to obtain FDA approval to use VBT in the peripheral arteries. The MOBILE Trial is designed to evaluate our newly designed peripheral vascular brachytherapy system and its effectiveness in reducing in-stent restenosis in the arteries of the leg. There are two phases in the MOBILE Trial: the Roll-in phase and the Randomized phase. Up to 150 patients will be part of the Roll-in phase, which means that they will not be randomized, but will all receive vascular brachytherapy treatment. If you are selected for the Randomized phase, you will be assigned by chance to receive VBT or no further treatment following your intervention performed by your physician. Approximately one-half of the patients enrolled will be randomly selected to receive VBT treatment; the other half will receive the current medical standard of care (no radiation).