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Study Details
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Objective
- – To observe and evaluate the efficacy, of Magic Touch SCB compared to one of the gold standard treatment for native vessel disease (everolimus eluting stent, EES)
- – International, multicentric, prospective, investigator-driven, open-label, randomized (1:1) clinical trial
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Endpoints
Primary Endpoints:
To verify the non-inferiority of Magic Touch SCB hypothesized in target lesion failure (TLF), a composite of cardiac death, ischemia-driven target lesion revascularization (TLR), target vessel myocardial infarction (MI), at 12 months.
Co-primary endpoint
To verify the non-inferiority of Magic Touch SCB hypothesized in target lesion failure (TLF), a composite of cardiac death, ischemia-driven target lesion revascularization (TLR), target vessel myocardial infarction (MI), at 12 months.
Secondary Endpoints:
To verify the non-inferiority of Magic Touch SCB hypothesized in target lesion failure (TLF), a composite of cardiac death, ischemia-driven target lesion revascularization (TLR), target vessel myocardial infarction (MI), at 12 months.
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Clinicaltrials.gov
NCT04893291
Patients Enrolled
1845
Study Countries
Italy
| Center | Investigator |
|---|---|
| Clinica Polispecialistica San Carlo, Milano | Dr. Guido Belli |
| Ospedale Sandro Pertini, Roma | Dr. Alessandro Sciahbasi |
| Ospedale Civile San Giuseppe Moscati, Aversa | Dr. Gianluca Caiazzo |
| Ospedale S. Antonio Abate, Erice Casa Santa | Dr. Dario Buccheri |
| ASST Grande Ospedale Metropolitano Niguarda, Milano | Dr. Irene Bossi |
| Fondazione Poliambulanza – Istituto Ospedaliero, Brescia | Dr. Diego Maffeo |
| Ospedale Civile Sant’Andrea, La Spezia | Dr. Alberto Menozzi |
| Ospedale Policlinico San Martino, Genova | Dr. Matteo Vercellino |
| Azienda Ospedaliero-Universitaria Sant’Andrea, Roma | Dr. Stefano Rigattieri |
| IRCCS Ospedale Galeazzi, Milano | Dr. Alfonso Ielasi |
| Policlinico Tor Vergata, Roma | Dr. Giuseppe Sangiorgi |
| Presidio Ospedaliero “S. Elia”, Caltanissetta | Dr. Alberto Pietro Chisari |
| Dr. Alberto Pietro Chisari, Palermo | Dr. Marco Caruso |
| Azienda Ospedaliera “Ospedali Riuniti Villa Sofia-Cervello”, Palermo | Dr. Elio Pieri |
| Azienda Ospedaliera Universitaria Integrata, Verona | Dr. Flavio Ribichini |
UK
| Center | Investigator |
|---|---|
| University Hospitals Birmingham, Birmingham | Dr. Sandeep Basavarajaiah |
| Altnagelvin Area Hospital, Londonderry | Dr. Aaron Peace |
| Golden Jubilee National Hospital, Clydebank | Dr. Angie Ghattas |
| St Bartholomew’s Hospital | Dr. Daniel Jones |
Brunei
| Center | Investigator |
|---|---|
| Jurong Park Medical Centre, Brunei Darussalam | Dr. Rajagopal Rajinikanth |
Bangladesh
| Center | Investigator |
|---|---|
| National Heart Foundation Hospital & Research Institute, Dhaka | Dr. Fazila Malik |
| National Institute of Cardiovascular Disease, Dhaka | Dr. Mohsin Ahmed |
| Bangladesh Specialized Hospital, Dhaka | Dr. Mir Jamal Uddin |
| LABAID Cardiac Hospital | Dr. Golam Azam |
Poland
| Center | Investigator |
|---|---|
| 1st Military Institute of Medicine, Lublin | Dr. Grzegorz Sobieszek |
| Heliodors Święcicki Clinical University Hospital, Poznań | Dr. Maciej Lesiak |
Spain
| Center | Investigator |
|---|---|
| Hospital General Universitario de Ciudad Real (HGUCR), Ciudad Real | Dr. Ignacio Sanchez-Perez |
| Hospital Universitario de Txagorritxu, Vitoria-Gasteiz – Araba | Dr. Alfonso Torres-Bosco |
| Hospital Universitario La Paz, Madrid | Dr. Raul Moreno |
| Hospital de la Princesa, Madrid | Dr. Fernardo Alfonso |
| Hospitales Marqués de Valdecilla (HUMV), Santander – Cantabria | Dr. José María de la Torre Hernández |
| Lucus Augusti University Hospital, Lugo | Dr. Carlos González Juanatey |
| Hospital Universitari i Politècnic La Fe, Valencia | Dr. Jorge Sanz Sánchez |
| Hospital Alvaro Cunqueiro, Vigo | Dr. Victor Alfonso Jiménez Díaz |
The Netherlands
| Center | Investigator |
|---|---|
| Maasstad Hospital, Rotterdam | Dr. Valeria Paradies |
| OLVG Onze Lieve Vrouwe Gasthuis location East, Amsterdam | Dr. Vink M.A |
| Amphia Breda Hospital, Breda | Dr. Menno van Gameren |
| Albert Schweitzer Hospital, Dordrecht | Dr. Oemrawsingh R.M |
| Haga Hospital, Den Haag | Dr. Samer Somi |
| Erasmus University Medical Center, Rotterdam | Dr. R. Diletti |
France
| Center | Investigator |
|---|---|
| Clinique Louis Pasteur, Essey-lès-Nancy | Dr. Julien Lemoine |
| Centre Hospitalier de Saint-Malo, Saint-Malo | Dr. Mourad Mejri |
| Groupe Hospitalier de La Rochelle-Ré-Aunis, La Rochelle | Dr. Ludovic Meunier |
| Hôpital Cochin, Paris | Dr. Fabien Picard |
| Hôpital Prive du Confluent, Nantes | Dr. Erwan Bressollette |
| Les Hôpitaux de Chartres, Le Coudray | Dr. Gregoire Range |
| Clinique Saint-Hilaire, Rouen | Dr. Matthieu Godin |
Malaysia
| Center | Investigator |
|---|---|
| Hospital Queen Elizabeth II, Sabah | Dr. Liew Houng Bang |
| University Malaya Medical Centre (UMMC) | Dr. Ahamad Syadi Mahmood Zuhdi |
Thailand
| Center | Investigator |
|---|---|
| Siriraj Hospital, Nakhon Pathom | Assoc. Prof. Nuttawut Wongpraparut |
| Ramathibodi Hospital, Nakhon Pathom | Dr. Mann Chandavimol |
Brazil
| Center | Investigator |
|---|---|
| Institute Dante Pazzanese of Cardiology, São Paulo | Dr. Ricardo Alves da Costa |
| InCor (Heart Institute), São Paulo | Dr. Alexandre Abizaid |
| INC (National Institute of Cardiology) | Dr. Cesar Rocha Medeiros |
| Instituto de Cardiologia do Rio Grande do Sul | Dr. Rogério Sarmento Leite |
| Hospital de Clínicas de Porto Alegre | Dr. Marco Vugman Wainstein |
| Hospital Santa Isabel | Dr. Ricardo Mauro Ghetti Cabral |
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