PICCOLETO XI Cohort A
Study Chairman: Prof. Bernardo Cortese
PI: Dr Filippo Gurgoglione, Dr Jasim Hasan
Scientific Committee: Dr Filippo Gurgoglione, Dr Jasim Hasan, Dr Bharat Kialani, Prof. Bernardo Cortese
PICCOLETO XI trial is an international, multicenter, investigator-driven study with a combined retrospective and prospective approach that aims to compare the performance of speciality balloons (scoring balloons, cutting balloons and OPN balloons) against standard balloons (semi compliant balloons and non compliant ones) prior to DCB angioplasty. The target population will be in-stent restenosis (Cohort A) and de novo lesions (Cohort B). The study primary endpoint is MACE at 1 year, secondary endpoints will be procedural success, post procedural diameter stenosis, myocardial infarction and TLR. This study reflects the real world patients and practices, is expected to generate hypotheses and construct the foundation for future randomised controlled trials.
Data collection for Cohort A was completed in Q2 2026, and the study will be presented at the upcoming TCT 2026 in San Diego.
Are you interested in participating in the study?