The purpose of this research is to evaluate the efficacy of a new investigational Sirolimus coated balloon device in the treatment of insufficient blood flow of legs (peripheral arterial disease, PAD).

This is a prospective, multi-center, double-arm, randomized, single-blind, evaluator blinded clinical trial designed to assess the safety and efficacy of the SelfWrap for prophylactic treatment intended to improve clinical outcomes for CKD patients referred for vascular access creation surgery.

To evaluate the safety and effectiveness of direct carotid access for stenting using
the Neuroguard IEP® Direct System in subjects at elevated risk for adverse events
following carotid endarterectomy (CEA).