Paclitaxel-coated balloons versus percutaneous transluminal angioplasty for infrapopliteal chronic total occlusions: the IN.PACT BTK randomised trial.

Background: Data are mixed concerning the safety and effectiveness of drug-coated balloons (DCBs) for treating below-the-knee (BTK) lesions.

Aims: The aim of this study was to assess the safety and effectiveness of the IN.PACT 014 paclitaxel-coated balloon catheter versus conventional percutaneous transluminal angioplasty (PTA) for infrapopliteal chronic total occlusions (CTOs) in patients with chronic limb-threatening ischaemia (CLTI).