A Prospective, Multi-Center, Single-Arm, Real-World Study Assessing the Clinical Use of the Bard® UltraScore™ Focused Force PTA Balloon
The objective of this study is to assess the clinical use of the Bard® UltraScore™ Focused Force PTA balloon in a heterogeneous patient population in a real world, on-label clinical application.
• Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
• Subject must be either a male or non-pregnant female ≥ 21 years of age with an expected lifespan sufficient to allow for completion of all study procedures.
• Subject must be willing to comply with the protocol requirements, including the follow-up procedures.
• Subject must have a target lesion (de novo lesion or prior failed treatment) that can be treated with the UltraScore™ Focused Force PTA balloon according to the Instructions for Use (IFU). Only a target lesion in the SFA, popliteal, or infra-popliteal arteries (posterior tibial, anterior tibial, or peroneal arteries) may be treated for this study.
• Subject must have an Above the Knee (ATK) or Below the Knee (BTK) target lesion with at least one vessel run-off.
• The target lesion must be able to be crossed using a guidewire (use of chronic total occlusion (CTO) or atherectomy is allowed).