PICCOLETO VI is a multicenter study that seeks to determine if paclitaxel drug-coated balloon is more effective than sirolimus drug-coated balloon in patients with complex coronary artery disease. The hypothesis behind this trial is that sirolimus may not be able to penetrate the vessel wall in complex lesions if the lesion preparation is not optimal. This trial is collecting data from various devices, including Sequent Please, Sequent Sirolimus (B Braun), Elutax (AR Baltic Medical), Selution (MedAlliance), Magic Touch (Concept Medical), Prevail (Medtronic), and Pantera Lux (Biotronik). In addition to evaluating the angiographic performance of these devices as a primary end point at 6-month follow-up, the study will also assess physiological performance of all DCBs by means of mu-FR. The trial has been presented during EuroPCR 2024, demonstrating significance and impact in the interventional cardiology community. Blinded core lab will assess the performance of these devices.
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