Angiosafe, Inc.

This research study is to learn more about the safety and effectiveness of a medical device called the "AngioSafe Peripheral-5 CTO Crossing System." This device is used as part of a medical procedure to restore blood flow of people with complete blockages (chronic total occlusions, or CTOs) in an arterial blood vessel of the leg below the knee. To fix the blockage the doctor must first deliver a guidewire through it so that other medical devices can be used to reduce the blockage. In this trial, the AngioSafe Peripheral-5 CTO Crossing System is the medical device that will be used to deliver the guidewire through the blockage. This will allow other devices needed for the procedure, such as treatment balloons and stents, to be used to open a pathway for blood to flow to the legs.

The study is designed to evaluate the safety and efficacy of the AngioSafe Peripheral CTO Crossing System.