Study Chairman: Prof. Bernardo Cortese
Steering committee: W.Wanha, M.Iannaccone, D.Jones, S. Fezzi, F.D’Ascenzo
PI: Filippo Gurgoglione
PICCOLETO IX PHENO is an investigator-driven, international multicenter observational study designed to evaluate the prognostic impact of de novo coronary artery disease phenotypes assessed by optical coherence tomography (OCT) prior to drug-coated balloon (DCB) angioplasty. The study aims to determine whether different OCT-derived plaque phenotypes are associated with different clinical outcomes following DCB-based percutaneous coronary intervention. The primary endpoint is target lesion revascularization at 12 months, with secondary endpoints including mortality and myocardial infarction-related outcomes. By integrating intracoronary imaging and clinical follow-up, this study seeks to improve lesion assessment and patient selection for DCB angioplasty and to support more personalized treatment strategies in coronary artery disease. The study plans to enroll a total of 600 patients (300 in the retrospective cohort, and 300 in the prospective cohort). The findings are expected to improve patient selection, lesion preparation and optimize stent-free revascularization strategies in contemporary coronary interventions.
Study received ethical approval in Italy for the prospective cohort and is expected to begin enrolment for the prospective cohort in Q3 2026.
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THE STUDY SITES AND CENTERS
Italy
Rivoli Infermi Hospital, ASLTO3 Rivoli, Turin
PI: Cerrato
Univ Piemonte Orientale, Alessandria
PI: Secco
Humanitas University, Pieve Emanuele-Milan
PI: Colombo/Gitto
University Hospital Careggi, Florence
PI: Mattesini
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna
PI: Ghetti
Department of Medical Sciences, University of Turin, Turin
PI: D’Ascenzo/Bruno
Department of Cardiology, Azienda Ospedaliero Universitaria of Parma, Parma
PI: Gurguglione
Presidio Ospedaliero Sant’Andrea di Vercelli, Vercelli, Piedmont
PI: Ugo/Franzino
Verona University Hospital
PI: Fezzi
Azienda Ospedaliera Papa Giovanni XXIII, Bergamo
PI: Canova
Department of Biomedicine and Prevention, Tor Vergata University, 00133 Rome
PI: Benedetto
IRCCS Ospedale Galeazzi-Sant’Ambrogio, Milan
PI: Ielasi
San Martino Hospital, Genova
PI: Vergallo.
Department of Cardiology, Catanzaro, Italy
PI:Cacia
France
Department of Cardiology, Centre Hospitalier La Rochelle Ré Aunis, La Rochelle
PI: Ludovic Meunier
Portugal
Hospital Espírito Santo, 7000-811 Évora
PI: David Neves
United Kingdom
Bart Hospital
PI: Dan Jones
Poland
Division of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice
PI: Wojciech Wańha
Ist Department of Cardiology Poznan University of Medical Sciences, Poznań
PI: Sylwia Iwańczyk
Department of Cardiology, Medical College of the University of Rzeszów, Rzeszów
PI: Piotr Wańczura
1st Department of Cardiology, Medical University of Gdansk, Gdansk
PI: Maksymilian Mielczarek
Department of Cardiology, State Medical Institute of the Ministry of Interior and Administration, Warsaw
PI: Robert Gil
Secong Department of Cardiology, Medical University of Silesia, Katowice
PI: Grzegorz Smolka
Department of Cardiology-Intensive Therapy and Internal Diseases, Poznan University of Medical Sciences, Poznań
PI: Miłosz Dziarmaga
Clinical Department of Cardiology and Cardiovascular Interventions, University Hospital, Kraków
PI: Stanisław Bartuś
Department of Cardiology, Wałbrzych
PI: Michał Kryjak
Finland
Heart Center, Central Hospital of North Karelia, Siunsote, Joensuu, Finland.
PI: Tuomas Rissanen
Spain
Department of Cardiology, Hospital Universitario de La Princesa, Madrid
PI: Fernando Alfonso