An Efficacy and Safety Study to Evaluate Ranger DEB for BTK Angioplasty in Patients With CLI (RANGER-BTK)

Inclusion Criteria

• •Age ≥18 years and ≤85 years
• •Patient signed an approved consent form
• •Patient has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Category 4, 5 or 6
• •Menopausal or under contraception for women
• •Negative serum β-HCG for women of childbearing age
• •Single or multiple lesions with ≥70% diameter stenosis (DS) of different lengths in one or more main below the knee vessels
• •Intraluminal recanalization of the target lesion with successful traversal of the target lesion and placement of the guidewire into the distal true lumen
• •Reference vessel reference diameter comprised between 2 and 4 mm
• •Patient with known hypersensitivity to paclitaxel
• •Patient unwilling or unlikely to comply with Follow-Up schedule
• •Life expectancy \<1 year (investigator's appreciation)
• •Planned major index limb amputation
• •Pregnant or breast feeding women