The PICCOLETO XI A-PREP Study

To compare the angiographic and clinical outcomes of aggressive versus standard balloon preparation during drug-coated balloon (DCB) angioplasty for in-stent restenosis (ISR). The study will evaluate whether more aggressive lesion preparation with cutting/scoring/OPN balloons improves outcomes compared to standard preparation with semi-compliant or non-compliant balloons.

NCT Number	NCT07391033
Lead Sponsor	Fondazione Ricerca e Innovazione Cardiovascolare ETS
Conditions	In-Stent Coronary Artery Restenosis, Coronary Artery Disease
Enrollment	500 participants
Start Date	2026-06-01
Primary Completion	2027-12-01 (estimated)
Study Completion	2028-06-01 (estimated)
Updated on ClinicalTrials.gov	2026-02-05