Drug-Eluting Balloons vs Mimetic Stents for Popliteal Artery Disease

More advanced and severe cases of chronic lower limb ischemia (the so-called critical lower limb ischemia) are painful and limiting conditions that impact on patients' quality of life.Until now, the available evidence for the femoropopliteal area only defines open surgery or endovascular treatment indications. However, the best strategy for endovascular procedures is still unclear. The popliteal artery is a challenging anatomical site for balloon angioplasty alone and standard nitinol stenting angioplasty.This randomized clinical trial aims to assess the superiority of nitinol stent angioplasty compared to pharmacoactive balloon angioplasty to treat critical lower limb ischemia due to popliteal artery arteriosclerosis.

Inclusion Criteria:Patients diagnosed of critical lower limb ischemia according to the TASC (TransAtlantic Inter-Society Consensus) working group.Patients admitted to the Vascular Surgery Department of the Bellvitge Hospital University to treat critical lower limb ischemia for endovascular treatment.With involvement of the Popliteal artery in-between the Hunter's canal and the start of the tibial artery branch.WOCBP must use highly effective methods of contraception.Patients who sign the written informed consent.Exclusion Criteria:Patients diagnosed of critical lower limb ischemia according to the TASC working group undergoing medical treatment or open surgery.Patients requiring amputation.Patients who underwent previous revascularization of the same limb (same artery).The main involvement is from an arterial territory other than the popliteal artery.Pregnant women.Inability of overcoming the arterial lesion during the endovascular procedure.Affected artery's diameter <4 mm.