This single-arm, prospective, multi-center CE marked study (IIT) is planned to include up to 80 subjects with CLI in below the knee vessels with de novo stenoses or non-stented re-stenotic in total greater or equal 70% stenosis or occlusion of lower limb lesion. During the index procedure at Day 1 patients will be treated with ULTRASCORE™ Focused Force balloon.~Follow-up investigations for evaluation of parameters for primary and secondary endpoints will be performed at 4 weeks, 6 months, and 12 months after the index procedure..
The purpose of this single-arm, exploratory study is to evaluate safety and performance of treatment of critical limb ischemia (CLI) with the ULTRASCORE™ Focused Force balloon.~Patients with CLI in below the knee vessels will receive a percutaneous transluminal angioplasty with the device and will be followed up for 12 months.