This study is for patients that have Critical Limb Ischemia (CLI), a form of Peripheral Arterial Disease (PAD) in which an artery (blood vessel) in their lower leg (calf) may have become blocked. This study involves the use of an investigational devices called a stent (a small mesh tube typically used to hold open blood vessels). The study device (stent) that will be used in this study is called the Bare Temporary Spur Stent System. It is intended to be used for treatment of Critical Limb Ischemia (CLI). The stent portion is made of nitinol, a metal commonly used in stents. It is unique from other similar approved devices, such as balloons and stents, because it consists of a delivery system that can deliver and re-capture the Bare Temporary Spur Stent and balloon, so that no metal is left behind in the body. The Bare Temporary Spur Stent has small spurs (spikes) on the outer surface of the stent, which pierce the inner lining of the artery. Together, the spurs and the stent may help to support the artery as it rebounds after the balloon inflation. The purpose of this is to help the artery stay open so that there is a channel for blood flow to the foot.
We will recruit 30 healthy human participants and measure their blood pressure in their arm as well as collect heart rate. We will then place two commercially-available, FDA-approved tourniquets around each thigh to stop blood flow to the legs. We will measure the blood pressure and heart rate in the arms again. We will then release the tourniquets after blood pressure measurement. This will be repeated three times with breaks between each repetition.