Study Chairman: Prof. Bernardo Cortese
Steering committee: Prof Bernardo Cortese, Prof Alexander Abizaid, Prof Fernando Alfonso, Prof Chema de la Torre Hernandez, Prof Stefano Rigattieri, Prof Antonio Greco
DSMB Coordinator: Prof Davide Capodanno
CEC Coordinator: Dr. Salvatore Brugaletta
TRANSFORM II is a multicenter, multinational, investigator-driven randomized clinical trial including centers from Europe, Asia, and South America and is comparing Magic Touch Sirolimus drug-coated balloon (DCB) to any everolimus-eluting stent in a broad spectrum of coronary artery disease (CAD) patients with native vessel disease diameters of 2–3.5 mm and lesion length up to 50 mm. This study is testing these 2 different revascularization strategies by assessing the non-inferiority of DCB as regards the primary endpoint of target lesion failure (TLF) and the superiority in terms of net adverse clinical events (NACE) at 1 year. Patients will be followed up clinically up to 5 years. The study has reached its primary endpoint and the results are expected to be presented in late 2026. This study has a DSMB coordinated by Prof Davide Capodanno, University of Catania, IT and a CEC coordinated by Dr Salvatore Brugaletta, Hospital Clínic in Barcelona, ES.
Will be presented as a late-breaking clinical trial at TCT 2026
Are you interested in participating in the study?
THE STUDY SITES AND CENTERS
Italy
Clinica San Carlo, Paderno Dugnano, Milan
PI: Guido Belli
Ospedale San Giuseppe Moscati, Aversa, CE
PI: Gianluca Caiazzo
ASST Grande Ospedale Metropolitano Niguarda, Milan
PI: Irene Bossi
Ospedale Civile Sant’Andrea, La Spezia
PI: Alberto Menozzi
Azienda Ospedaliero-Universitaria Sant’Andrea, Rome
PI: Stefano Rigattieri
Policlinico Tor Vergata, Rome
PI: Giuseppe Sangiorgi
Azienda Ospedaliera “Ospedali Riuniti Villa Sofia-Cervello” Palermo
PI: Elio Pieri
Ospedale Sandro Pertini, Rome
PI: Alessandro Sciahbasi
Ospedale S. Antonio Abate, Erice Casa Santa, Trapani
PI: Dario Buccheri
Fondazione Poliambulanza Brescia
PI: Diego Maffeo
Ospedale Policlinico San Martino, Genova
PI: Matteo Vercellino
IRCCS Ospedale Galeazzi – Sant’Ambrogio, Milan
PI: Alfonso Ielasi
A.R.N.A.S. Ospedali Civico Di Cristina Benfratelli Palermo
PI: Marco Caruso
Azienda Ospedaliera Universitaria Integrata Verona
PI: Flavio Ribichini
United Kingdom
University Hospitals Birmingham
PI: Sandeep Basavarajaiah
Golden Jubilee National Hospital
PI: Angie Ghattas
Altnagelvin Area Hospital
PI: Aaron Peace
St Bartholomew’s Hospital, W Smithfield, London EC1A 7BE, United Kingdom
PI: Daniel Jones
France
Clinique Louis Pasteur 7 Rue Parmentier, 54270 Essey-lès-Nancy, Francia
PI: Julien Lemoine
Groupe Hospitalier de La Rochelle
PI: Ludovic Meunier
Les Hôpitaux de Chartres, Hôpital Louis Pasteur, 4 Rue Claude Bernard 28630, Le Coudray, France
PI: Gregoire Range
Centre Hospitalier de Saint-Malo 1 Rue de la Marne, 35400 Saint-Malo, Francia
PI: Mourad Mejri
Hôpital Prive du Confluent, 4 Rue Éric Tabarly, 44000 Nantes, France
PI: Erwan Bressollette
Clinique Saint-Hilaire, 2 Pl. Saint-Hilaire, 76000 Rouen, France
PI: Matthieu Godin
Poland
1st Military Institute of Medicine, Aleje Racławickie 23, 20-049 Lublin
PI: Grzegorz Sobieszek
Heliodors Święcicki Clinical Univeristy Hospital, Ul. Stanislawa Przybyszewskiego 49, 60-355 Poznań
PI: Maciej Lesiak
Thailand
Ramathibodi Hospital, Mahidol University
PI: Mann Chandavimol
Spain
Hospital General Universitario de Ciudad Real (HGUCR), Ciudad Real
PI: Ignacio Sanchez-Perez
Hospital Universitario La Paz, Madrid
PI: Raul Moreno Gómez
Hospital Universitario Marqués de Valdecilla (HUMV), Santander
PI: Jose M De La Torre Hernandez
Hospital Universitario y Politécnico La Fe, Valencia
PI: Jorge Sanz Sánchez
Hospital Universitario de Txagorritxu, Vitoria-Gasteiz
PI: Merche Sanz Sanchez
Hospital de la Princesa, Madrid
PI: Fernando Alfonso
Lucus Augusti University Hospital, Lugo
PI: Carlos González Juanatey
Hospital Alvaro Cunqueiro-University Hospital of Vigo, Vigo
PI: Victor Alfonso Jiménez Díaz
Netherland
Albert Schweitzer Hospital, Dordrecht
PI: Oemrawsingh R.M
Erasmus University Medical Center, Rotterdam
PI: Roberto Diletti
Maasstad Hospital, RotterdamPI: Valeria Paradies
OLGV Onze Lieve Vrouwe Gasthuis location East, Amsterdam
PI: Vink M.A
Haga Hospital Els Borst-Eilersplein 275, Den Haag
PI: Samer Somi
Bangladesh
National Heart Foundation Hospital & Research Institute
PI: Fazila Malik
Bangladesh Specialized Hospital Ltd, Dhaka, Bangladesh
PI: Mir Jamal Uddin
Kurmitola General Hospital, Dhaka
PI: Mohsin Ahmed
National Institute of Cardiovascular Disease, Dhaka, Bangladesh
PI: Sayeedur Rahman Khan Rumi
LABAID Cardiac Hospital, Dhaka, Bangladesh
PI: Golam Azam
Malaysia
Hospital Queen Elizabeth II, Sabah
PI: Liew Houng Bang
University Malaya Medical Centre (Teaching and Research Hospital)
PI: Ahmad Syadi
Brunei
Jurong Park Medical Centre JPMC
PI: Paula Mota
Brazil
Institute Dante Pazzanese of Cardiology
PI: Ricardo Costa
INC (National Institute of Cardiology), Rio de Janeiro, RJ
PI: Cesar Medeiros
Hospital Santa Isabel R. Frei Cornélio, 200, Ubá- MG
PI: Ricardo Ghetti
InCor (Heart Institute)
PI: Carlo Campos
Hospital de Clínicas de Porto Alegre
PI: Marco Wainstein