PICCOLETO-XIImpact of Aggressive vs Standard Lesion Preparation on Drug-coated Balloon Angioplasty for In-stent Restenosis

The PICCOLETO XI A-PREP study focuses on understanding the impact of different lesion preparation strategies used before drug-coated balloon (DCB) angioplasty for in-stent restenosis (ISR). In-stent restenosis is a condition where a previously placed stent narrows again, posing a significant challenge. The DCB angioplasty is a treatment method that doesn't involve adding more metal layers, which could be beneficial. The study emphasizes the importance of proper lesion preparation for better drug delivery and reduced risk of restenosis. It involves patients who will be grouped based on their lesion preparation strategy, either aggressive or standard. The aggressive approach uses tools like cutting, scoring, or specific types of balloons, while the standard approach uses semi-compliant or non-compliant balloons. The study aims to improve care for those with in-stent restenosis by finding the best preparation method. During the study, participants will undergo their assigned preparation strategy and subsequent DCB angioplasty. The results will be measured based on Major Adverse Cardiovascular Events (MACE), which is a combination of three potential outcomes: cardiac death, non-fatal heart attack, or the need for another procedure on the same treated area. These outcomes will be assessed at one year and the longest available follow-up period. The study's findings could provide insights into the most effective and safe preparation strategies for in-stent restenosis treatment.