Lower-Limb Adventitial Infusion of DexaMethasone Via Bullfrog to Reduce Occurrence of Restenosis After Percutaneous Transluminal Angioplasty Revascularization

Inclusion Criteria: Screening Criteria: * Age ≥18 years * Patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed an IRB/EC approved consent form * Female patients of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation * Patient has documented chronic Critical Limb Ischemia (CLI) in the target limb from the popliteal artery to the ankle joint prior to the study procedure with Rutherford Category 4, 5 or 6 * Life expectancy \>1 year in the Investigator's opinion Angiographic Criteria: * Successful revascularization of the TL with less than 30% residual stenosis, run-off down to the foot and direct in-line flow to any foot wound * Reference vessel(s) diameter ≥2 mm * Single or multiple atherosclerotic lesion ≥70% in at least one infrapopliteal crural target vessel including the tibioperoneal trunk that totals up to 30 cm in length (with no greater than 5 cm length of contiguous intervening normal artery), with possible extension into the popliteal artery distal to the center of the knee joint space (the P3 segment) Exclusion Criteria: Screening Criteria: * Patient unwilling or unlikely to comply with visit schedule * Planned major index limb amputation * Active foot infection; however, osteomyelitis in the toes or mild cellulitis around the perimeter of gangrene or small ulce…