Study Assessing the Clinical Use of the Bard® UltraScore™ Focused Force PTA Balloon (H-41678)
The purpose of this study is to assess the clinical use of the UltraScore balloon to treat a blockage, or stenosis, in your leg. The blockage may be above or below the knee. Above the knee (ATK) arteries are the superficial femoral artery (SFA – the artery which runs the length of your thigh) or popliteal artery (the artery running from the lower thigh to the knee). Below the knee (BTK) arteries are the tibial (the artery on the front of your leg that runs from the knee to the ankle) or the peroneal (the artery on the back of your leg that runs from the knee to the ankle). This device has been cleared by the U.S. Food and Drug Administration (FDA) and is being evaluated for its on-label use. The UltraScore balloon is called a scoring balloon because of the two wires on the outside of the balloon. There are several scoring balloons on the market in the United States, including UltraScore and another made by Bard. Scoring balloons are sometimes used first on blockages of arteries to prepare the artery for a secondary treatment. Typical secondary treatments may include use of a drug coated balloon, a stent, or other procedures.
Age 21 years or older
Lesion in the SFA, popliteal, or infra-popliteal arteries.
Acute limb ischemia
Rutherford category 6