Prospective Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus Conventional Balloon Angioplasty in Treating Below the Knee Arterial Lesions in Chronic Limb Threatening Ischemia: The CRURAL DEB Study

This single-center prospective randomized study could not demonstrate superiority of DCB compared with conventional balloon angioplasty regarding the primary endpoint, as primary patency, when treating BTK arterial lesions in patients with CLTI.Clinical ImpactThis randomised trial aims to pragmatically investigate whether there is a clinically relevant difference between drug eluting angioplasty and standard plain old balloon angioplasty in treating below the knee arterial lesions in subjects with chronic limb threatening ischemia. Regarding the primary endpoint variable, the study was not able to reveal a significant DCB superiority in primary patency.