Orbital atherectomy for infrapopliteal disease: device concept and outcome data for the OASIS trial.

Objective: The purpose of this study was to assess the safety and short-term efficacy of orbital atherectomy for chronic infrapopliteal arterial occlusive disease.

Background: Infrapopliteal occlusive disease is a common cause of critical limb ischemia and claudication. There are no American College of Cardiology/American Heart Association guidelines for infrapopliteal revascularization for chronic limb ischemia.