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Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels - TRANSFORM II
Sponsor: Fondazione Ricerca e Innovazione Cardiovascolare ETS
Summary
International, multicentric, prospective, investigator-driven, open-label, randomized (1:1) clinical trial to observe and evaluate the efficacy, of Magic Touch Sirolimus Coated Balloon (SCB) compared to one of the gold standard treatment for native vessel disease (everolimus-eluting stent, EES).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1820
Start Date
2021-11-16
Completion Date
2030-08-30
Last Updated
2026-02-19
Healthy Volunteers
No
Interventions
Everolimus Eluting Stent
Patients assigned to this Arm will have an EES implanted after pre-dilatation, the angiography will be conducted as standard of care
Sirolimus Coated Balloon
Patients assigned to this Arm will be treated with Magic Touch Drug Coated Balloon (DCB) after pre-dilatation, the angiography will be conducted as standard of care
Locations (53)
Bangladesh Specialized Hospital Lt
Dhaka, Bangladesh
Kurmitola General Hospital
Dhaka, Bangladesh
LABAID Cardiac Hospital
Dhaka, Bangladesh
National Heart Foundation Hospital & Research Institute
Dhaka, Bangladesh
National Institute of Cardiovascular Disease
Dhaka, Bangladesh
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
INC (National Institute of Cardiology),
Rio de Janeiro, Brazil
InCor (Heart Institute)
São Paulo, Brazil
Institute Dante Pazzanese of Cardiology
São Paulo, Brazil
Hospital Santa Isabel R. Frei Cornélio
Ubá, Brazil
Jurong Park Medical Centre JPMC
Bandar Seri Begawan, Brunei
Clinique Louis Pasteur
Essey-lès-Nancy, France
Groupe Hospitalier de La Rochelle
La Rochelle, France
Les Hôpitaux de Chartres, Hôpital Louis Pasteur
Le Coudray, France
Hôpital Prive du Confluent, 4 Rue Éric Tabarly
Nantes, France
Clinique Saint-Hilaire
Rouen, France
Centre Hospitalier de SaintMalo
St-Malo, France
Ospedale San Giuseppe Moscati
Aversa, Italy
Fondazione Poliambulanza
Brescia, Italy
Ospedale Policlinico San Martino
Genova, Italy
Ospedale Civile Sant'Andrea
La Spezia, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Istituto clinico Sant'Ambrogio
Milan, Italy
Clinica Polispecialistica San Carlo
Paderno Dugnano, Italy
A.R.N.A.S. Ospedali Civico Di Cristina Benfratelli
Palermo, Italy
Azienda Ospedaliera "Ospedali Riuniti Villa Sofia-Cervello"
Palermo, Italy
Ospedale Sandro Pertini
Roma, Italy
Azienda Ospedaliero-Universitaria Sant'Andrea
Roma, Italy
Policlinico Tor Vergata
Roma, Italy
Ospedale S. Antonio Abate
Trapani, Italy
Azienda Ospedaliera Universitaria Integrata
Verona, Italy
Hospital Queen Elizabeth II
Kota Kinabalu, Malaysia
University Malaya Medical Centre (Teaching and Research Hospital)
Kuala Lumpur, Malaysia
OLVG Onze Lieve Vrouwe Gasthuis location East
Amsterdam, Netherlands
Albert Schweitzer Hospital
Dordrecht, Netherlands
Erasmus University Medical Center
Rotterdam, Netherlands
Maasstad Hospital
Rotterdam, Netherlands
Haga Hospital Els Borst
The Hague, Netherlands
1st Military Institute of Medicine
Lublin, Poland
Heliodors Święcicki Clinical Univeristy Hospital, Ul
Poznan, Poland
Hospital General Universitario de Ciudad Real (HGUCR)
Ciudad Real, Spain
Hospital Universitario Lucus Augusti (HULA)
Lugo, Spain
Hospital de La Princesa
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Marqués de Valdecilla (HUMV)
Santander, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Spain
Hospital Alvaro Cunqueiro-University Hospital of Vigo
Vigo, Spain
Hospital Universitario de Araba
Vitoria-Gasteiz, Spain
Ramathibodi Hospital, Mahidol University
Bangkok, Thailand
University Hospitals Birmingham
Birmingham, United Kingdom
Golden Jubilee National Hospital
Clydebank, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
Altnagelvin Area Hospital
Londonderry, United Kingdom