Coronary Artery Disease Clinical Trial
— e-UltimasterOfficial title:
Prospective, Single Arm, Multi-centre, Observational Registry to Further Validate Safety and Efficacy of the Ultimaster Des System in Unselected Patients Representing Everyday Clinical Practice
| NCT number | NCT02188355 |
| Other study ID # | T123E2 |
| Secondary ID | |
| Status | Active, not recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 2014 |
| Est. completion date | June 2020 |
| Verified date | October 2019 |
| Source | Terumo Europe N.V. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
The e-Ultimaster will further validate the safety and efficacy of Ultimaster DES system in unselected patients representing everyday clinical practice. Also the study will assess the impact of non-compliance with dual antiplatelet therapy, one month after stent implementation (frequently observed in every day clinical practice), on stent thrombosis.
| Status | Active, not recruiting |
| Enrollment | 37000 |
| Est. completion date | June 2020 |
| Est. primary completion date | June 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 18 years or older - eligible for percutaneous coronary intervention using DES (and RVD matches available Ultimaster DES sizes) - informed about the nature of the study and agreess to its provisionss and has provided written informed consent as approved by the Institutional Review Board / Ethics committee of the respective clinical site, wherever such requirement exists. Exclusion Criteria: - following instruction for use |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Fundación Favaloro | Buenos Aires | |
| Argentina | Hospital San Juan de Dios | Buenos Aires | |
| Argentina | Hospital Universitario Austral | Buenos Aires | |
| Argentina | Instituto Cardiovascular de Buenos Aires | CABA - Buenos Aires | |
| Argentina | Clinica Centro Médico Privado Junin | Junin | |
| Argentina | Clinica Monte Grande | Monte Grande | |
| Argentina | Instituto Cardiovascular de Rosario | Rosario | |
| Argentina | Sanatorio San Miguel | San Miguel | |
| Armenia | Medical center Gyumri CJSC | Gyumri | |
| Armenia | "QANCOR" cardiovascular MC LLC | Yerevan | |
| Armenia | Astghik Medical Center (Natali Farm) | Yerevan | |
| Armenia | QANCOR Cardiovascular MC LLC | Yerevan | |
| Armenia | Republican Medical Center Armenia CJSC | Yerevan | |
| Armenia | Yerevan State medical University Hospital | Yerevan | |
| Austria | Medizinische Universität Graz | Graz | |
| Austria | AKh Linz | Linz | |
| Austria | Hanusch Krankenhaus der Wiener Gebietskrankenkasse | Vienna | |
| Austria | Krankenanstalt Rudolfstiftung der Stadt Wien | Vienna | |
| Austria | Vienna General Hospital | Vienna | |
| Bangladesh | National Heart Foundation Hospital and Research Institute | Dhakuli | |
| Belarus | City Clinical Emergency Hospital | Minsk | |
| Belarus | RSPC | Minsk | |
| Belgium | Olvz Aalst | Aalst | |
| Belgium | OLVZ Aalst, Onze Lieve Vrouw Ziekenhuis vzw-Campus Aalst | Aalst | |
| Belgium | Imelda Ziekenhuis | Bonheiden | |
| Belgium | Imelda Ziekenhuis - Bonheiden | Bonheiden | |
| Belgium | Cliniques Saint-Luc | Brussels | |
| Belgium | CHU Charleroi | Charleroi | |
| Belgium | AZ Sint Lucas | Gent | |
| Belgium | Epicura-Hornu | Hornu | |
| Belgium | Jan Yperman Ziekenhuis | Ieper | |
| Belgium | CHR de la Citadelle | Liège | |
| Belgium | Hôpital Ambroise Paré de Mons | Mons | |
| Belgium | CHU UCL Mont Godinne Namur | Yvoir | |
| Brazil | Hospital Felicio Rocho | Belo Horizonte | |
| Brazil | Unimed Joinville | Joinville | |
| Brazil | Hospital Monte Sinai | Juiz De Fora | |
| Brazil | UNICOR | Linhares | |
| Brazil | Paraná Medical Research Center | Maringá | |
| Brazil | Eurolatino Natal Medical Research | Natal | |
| Brazil | Hospital São Vicente de Paulo | Passo Fundo | |
| Brazil | Hospital Moinhos de Vento | Porto Alegre | |
| Brazil | Hospital e Maternidade Dr. Christóvão da Gama | Santo André | |
| Brazil | Beneficência Portuguesa de São Paulo | São Paulo | |
| Brazil | Hospital Santa Cruz | São Paulo | |
| Bulgaria | "Mhat Puls" Ad | Blagoevgrad | |
| Bulgaria | City clinic Burgas | Burgas | |
| Bulgaria | MBAL Haskovo AD | Haskovo | |
| Bulgaria | Cardiolife-Lovech | Lovech | |
| Bulgaria | Mbal Montana City Clinic Sveti Georgi | Montana | |
| Bulgaria | MBAL St. Karidad | Plovdiv | |
| Bulgaria | MHAT Plovdiv | Plovdiv | |
| Bulgaria | University Hospital Sveti Georgi | Plovdiv | |
| Bulgaria | City clinic University Multi-Profile Hospital for Acute Care,Sofia | Sofia | |
| Bulgaria | MBAZ-II-Sofia | Sofia | |
| Bulgaria | MHATEM N.I.Pirogov | Sofia | |
| Bulgaria | National Heart Hospital | Sofia | |
| Bulgaria | Tokuda Hospital | Sofia | |
| Bulgaria | UMHAT Alexandrovska | Sofia | |
| Bulgaria | UMHAT St.Ekaterina | Sofia | |
| Bulgaria | Trakiya Hospital | Stara Zagora | |
| Bulgaria | Umbal Stojan Kirkovich | Stara Zagora | |
| Bulgaria | Specialized Cardiology Hospital for Active Treatment | Varna | |
| Bulgaria | MBAL Sveta Petka Vidin | Vidin | |
| Chile | Hospital Antofagasta | Antofagasta | |
| Chile | Hospital Guillermo Grant Benavente | Concepcion | |
| Chile | Hospital Regional Puerto Montt | Puerto Montt | |
| Chile | Clinica Bicentenario | Region Metropolitana | |
| Chile | Clinica Santa Maria | Santiago | |
| Chile | Hospital San Borja Arriaran | Santiago | |
| Chile | Hospital San Juan de Dios | Santiago | |
| Chile | Hospital Van Buren | Valparaíso | |
| Colombia | Clinica Marly | Bogota | |
| Colombia | Clinica Shaio | Bogota | |
| Colombia | Fundación Cardiovascular de Colombia | Bucaramanga | |
| Colombia | Instituto del corazón de Bucaramanga | Bucaramanga | |
| Colombia | Centro Cardiovascular de Caldas | Manizales | |
| Czechia | Fakultni nemocnice u svate Anny v Brne | Brno | |
| Czechia | Karlovarská Krajská nemocnice | Karlovy Vary | |
| Czechia | FNKV | Prag | Srobarova |
| Czechia | Kardiologie na Bulovce | Prague | |
| Czechia | Krajska nemocnice t. Bati | Zlín | |
| Egypt | Police Hospital | Alexandria | |
| Egypt | Al Hayat Hospital | Cairo | |
| Egypt | Al Nakheel Hospital | Cairo | |
| Egypt | Dr Ahmed Abdel Aziz Multicenter | Cairo | |
| Egypt | Dr Hisham Ammar Multicenter | Cairo | |
| Egypt | Dr Hussien Heshmat - As Salam International Hospital | Cairo | |
| Egypt | Dr. Tarek Rashid | Cairo | |
| Egypt | Dr.Hazem Al Guindi | Cairo | |
| Egypt | El Marwa Hospital | Cairo | |
| Egypt | Italian Hospital | Cairo | |
| Egypt | Nile Badrawy Hospital | Cairo | |
| Egypt | Sheraton Hospital for Medical Services | Cairo | |
| Egypt | Wadi El Neel Hospital | Cairo | |
| Egypt | Um El Korra Hospital | El Gharbeya | |
| Egypt | L-Fouad Cardiac Center | Menofia | |
| Estonia | East-Tallinn Central Hospital | Tallinn | |
| Estonia | North Estonia Medical Center | Tallinn | |
| France | CHU Angers | Angers | |
| France | Hopital Européen de Paris La Roseraie | Aubervilliers | |
| France | Clinique Rhône Durance | Avignon | |
| France | GCS Cardiologique de Bayonne | Bayonne | |
| France | Clinique St Augustin Bordeaux-Centre d'exploration-chirurgie | Bordeaux | |
| France | CHU Caen | Caen | |
| France | Hopital Privé Saint Martin | Caen | |
| France | CHU Clermont-Ferrand | Clermont-Ferrand | |
| France | Pôle Santé République Clermont Ferrand | Clermont-Ferrand | |
| France | Hopital Albert Schweitzer GHCA Colmar | Colmar | |
| France | CH Sud Francilien | Corbeil Essonnes | |
| France | Clinique de Fontaine | Dijon | |
| France | Groupement mutualiste de Grenoble | Grenoble | |
| France | CH Haguenau | Haguenau | |
| France | CH de Marne la Vallée | Jossigny | |
| France | CHD Vendée La Roche sur Yon | La Roche sur Yon | |
| France | Groupe Hospitalier de la Rochelle Ré Aunis | La Rochelle | |
| France | CH Louis Pasteur-Le Coudray | Le Coudray | |
| France | Hopital privé La Louviere-Lille | Lille | |
| France | CH St Joseph St Luc Lyon | Lyon | |
| France | Hopital Privé Jacques Cartier Massy | Massy | |
| France | Clinique du Pont de Chaume Montauban | Montauban | |
| France | Clinique du Milénaire | Montpellier | |
| France | CH Montreuil | Montreuil | |
| France | Clinique Diaconat Fonderie Mulhouse | Mulhouse | |
| France | Clinique Louis Pasteur Essey les Nancy | Nancy | |
| France | Le Confluent Nouvelles Cliniques Nantaises | Nantes | |
| France | Clinique Ambroise Paré | Neuilly Sur Seine | |
| France | Polyclinique les Fleurs | Ollioules | |
| France | CHR Orléans | Orléans | |
| France | Groupe Hopitalier Paris Saint Joseph | Paris | |
| France | Centre Hospitalier de Pau | Pau | |
| France | Hôpital Privé St Martin de Pessac | Pessac | |
| France | Hopital privé St Martin Pessac (DR Levy) | Pessac | |
| France | CHU de Poitiers | Poitiers | |
| France | CH René Dubos Pontoise | Pontoise | |
| France | CHIC Quimper | Quimper | |
| France | Hopiatl Privé Claude Galien Quincy | Quincy sous sénart | |
| France | Clinique Saint-Laurent Rennes | Rennes | |
| France | Clinique ST Hilaire Rouen | Rouen | |
| France | CH Yves le Foll - Saint Brieuc | Saint Brieuc | |
| France | CH La Timone Marseille | Saint Pierre | |
| France | CH Général de Saint Quentin | Saint-Quentin | |
| France | Institut Arnault Tzanck St Laurent du Var | St Laurent du Var | |
| France | Nouvel Hopital Civil de Strasbourg | Strasbourg | |
| France | Clinique Saint Joseph | Trélazé | |
| France | CH de Valence | Valence | |
| France | CH Bretagne Atlantique | Vannes | |
| Georgia | Diagnostic Services Ltd. Cardio Clinic | Tbilisi | |
| Georgia | Helsicore Clinic | Tbilisi | |
| Georgia | JoAnn Medical Center | Tbilisi | |
| Hungary | Semmelweis University | Budapest | |
| Hungary | Hospital Pándy Kálmán | Gyula | |
| Hungary | Moritz Kaposi General Hospital | Kaposvár | |
| Hungary | Szatmar-Szabolcs-Bereg county hospital and university teaching hospital | Nyíregyháza | |
| Hungary | Pecs University | Pecs | |
| Hungary | Markusovszky University Teaching Hospital | Szombathely | |
| Iceland | Landspitali National University hospital | Reykjavik | |
| India | Kamalnayan Bajaj Hospital | Aurangabad | |
| India | MMM, Chennai | Chennai | |
| India | G. Kuppuswamy Naidu Memorial Hospital (GKNM), Coimbatore | Coimbatore | |
| India | Medanta Hospital, Delhi | Delhi | |
| India | Care Hospital, Hyderabad | Hyderabad | |
| India | SMS Hospital, Jaipur | Jaipur | |
| India | BM Birla, Kolkata | Kolkata | |
| India | KMC, Mangalore | Mangalore | |
| India | Fortis Hospital, Mohali | Mohali | |
| India | H.J. Doshi Ghatkopar Hindusabha Hospital | Mumbai | |
| India | Hiranandani Hospital, Mumbai | Mumbai | |
| India | Wockhardt Hospital, Nagpur | Nagpur | |
| India | Maharaja Agrasen Hospital, New Delhi | New Delhi | |
| India | Max Super Speciality Hospital, Saket, Delhi | New Delhi | |
| India | SCTIT, Trivanderum | Trivanderum | |
| Indonesia | Medistra Hospital | Jakarta | |
| Indonesia | National Cardiovascular Center Harapan Kita | Jakarta Barat | |
| Indonesia | RSUPN Cipto Mangunkusumo | Jakarta Pusat | |
| Indonesia | RSUP Fatmawati General Hospital | Jakarta Selatan | |
| Indonesia | Binawaluya Cardiac Center | Jakarta Timur | |
| Indonesia | Awal Bros Hospital | Makassar | |
| Indonesia | Dr. Wahidin Sudirohusodo General Hospital | Makassar | |
| Indonesia | Saiful Anwar Hospital | Malang | |
| Indonesia | Dr. Soetomo General Hospital | Surabaya | |
| Ireland | Cork University Hospital | Cork | |
| Ireland | University Hospital Galway | Galway | |
| Ireland | University Hospital Limerick | Limerick | |
| Israel | Rambam Medical Center | Haifa | |
| Israel | Galilee Medical Center | Nahariya | |
| Israel | Assaf Harofeh Medical Center | Tzrifin | |
| Israel | Ziv M.C | Zefat | |
| Japan | Kansai Rosai Hospital | Amagasaki Hyougo | |
| Japan | Kokura Memorial Hospital | Fukuoka | |
| Japan | Iwaki Kyoritsu General Hospital | Fukushima | |
| Japan | Tokai University Hachiouji Hospital | Hachioji | |
| Japan | Hakodate Municipal Hospital | Hakodate Hokkaido | |
| Japan | Seirei Hamamatsu General Hospital | Hamamatsu | |
| Japan | Kakogawa East City Hospital | Kakogawa | |
| Japan | Shonan Kamakura General Hospital | Kanagawa | |
| Japan | Komaki City Hospital | Komaki Aichi | |
| Japan | Kyoto Katsura Hospital | Kyoto | |
| Japan | Gunma Prefectural Cardiovascular Center | Maebashi | |
| Japan | Mie Heart Center | Mie | |
| Japan | Osaka General Medical Center | Osaka | |
| Japan | Sakurabashi Watanabe Hospital | Osaka | |
| Japan | Saitama Cardiovascular and Respiratory Center | Saitama | |
| Japan | Mimihara General Hospital | Sakai | |
| Japan | Osaka Rosai Hospital | Sakai Osaka | |
| Japan | Sapporo Higashi Tokushukai Hospital | Sapporo Hokkaido | |
| Japan | Saiseikai Senri Hospital | Suita | |
| Japan | Okamura Memorial Hospital | Suntougun Shizuoka | |
| Japan | Higashi Takarazuka Satoh Hospital | Takarazuka Hyougo | |
| Japan | Kouseikai Takai Hospital | Tennri Nara | |
| Japan | Saiseikai Yamaguchi General Hospital | Yamaguchi | |
| Japan | Saiseikai Yokohama City Eastern Hospital | Yokohama | |
| Japan | Seirei Yokohama Hospital | Yokohama | |
| Japan | Showa University Fujigaoka Hospital | Yokohama Kanagawa | |
| Jordan | Jordan Hospital | Amman | |
| Kazakhstan | Aktobe Regional Hospital | Aktobe | |
| Kazakhstan | Medical University Clinic West Kazakhstan | Aktobe | |
| Kazakhstan | Almaty city cardio center | Almaty | |
| Kazakhstan | National Surgery Center Almat | Almaty | |
| Kazakhstan | City Hospital #2 | Astana | |
| Kazakhstan | JSC Nat. Scient. Cardiosurgery Ctr. | Astana | |
| Kazakhstan | National Scientific Medical Research Center JSC | Astana | |
| Kazakhstan | Regional Cardiosurgery Center | Karaganda | |
| Kazakhstan | Karagandy Regional Cardiac Center | Karagandy | |
| Kazakhstan | Akmola Regional Hospital | Kokshetau | |
| Kazakhstan | Pavlodar Regional Cardiologic center | Pavlodar | |
| Kazakhstan | Cardiology Center Petropavl | Petropavl | |
| Kazakhstan | Rudnyi City Hospital | Rudnyi | |
| Kazakhstan | University Hospital of Semey | Semey | |
| Kazakhstan | Shymkent Regional Cardiology Center | Shymkent | |
| Kazakhstan | Clinical Center of Cardiac Surgery and Transplantation | Taraz | |
| Kuwait | Sabah Al Ahmad Cardiac Center | Kuwait | |
| Lebanon | Hopital Abou Jaoudé | Beirut | |
| Lebanon | Labib Medical Center | Sidon | |
| Lithuania | LSMU Kauno Klinikos | Kaunas | |
| Lithuania | Klaipeda Seamen's Hospital | Klaipeda | |
| Malaysia | Hospital Sultanah Bahiyah | Alor Setar, Kedah | |
| Malaysia | Hospital Serdang | Kajang | |
| Malaysia | Desa Park City | Kuala Lumpur | |
| Malaysia | HSC Medical Center | Kuala Lumpur | |
| Malaysia | Hospital Tengku Ampuan Afzan | Kuantan | |
| Malaysia | UiTM Sg. Buloh Campus | Sungai Buloh | |
| Mexico | Fray Juan de San Miguel | Michoacan | |
| Mexico | Clinica Hospital San Jose de Navojoa SA de CV | Sonora | |
| Mexico | Hospital Star Médica Merida | Yucatán | |
| Morocco | Clinique Achifaa de Casablanca | Casablanca | |
| Morocco | CLINIQUE INTERNATIONALE de Marrakech | Marrakech | |
| Morocco | Clinique Grant Atlas | Marrakesh | |
| Morocco | Cherradi_Clinique Agdal | Rabat | |
| Netherlands | Meander Amersfoort | Amersfoort | |
| Netherlands | Rijnstate | Arnhem | |
| Netherlands | Amphia Ziekenhuis | Breda | |
| Netherlands | Jeroen Bosch Ziekenhuis | Den Bosch | |
| Netherlands | Medisch Centrum Haaglanden | Den Haag | |
| Netherlands | Albert Schweitzer Ziekenhuis | Dordrecht | |
| Netherlands | Catharina Hospital | Eindhoven | |
| Netherlands | Catharina Ziekenhuis | Eindhoven | |
| Netherlands | Scheper Ziekenhuis | Emmen | |
| Netherlands | Medisch Spectrum Twente | Enschede | |
| Netherlands | Medisch Centrum Leeuwarden | Leeuwarden | |
| Netherlands | Maasstad Ziekenhuis | Rotterdam | |
| Netherlands | Zorgzaam Ziekenhuis Zeeuws-Vlaanderen | Terneuzen | |
| Netherlands | VieCuri Medical Centre | Venlo | |
| North Macedonia | City General Hospital 8th September Skopje | Skopje | |
| North Macedonia | University Clinic of Cardiology | Skopje | |
| Oman | Muscat Private Hospital | Muscat | |
| Poland | Miedziowe Centrum Zdrowia | Lubin | |
| Poland | Szpital Kliniczny Przemienienia Panskiego UM im. K. Marcinkowskiego w Poznaniu | Poznan | |
| Poland | Infant Jesus Teaching Hospital | Warsaw | |
| Poland | Instytut Kardiologii im. Prymasa Tysiaclecia Stefana Kardynala Wyszynskiego | Warsaw | |
| Portugal | Hospital Santa María | Lisboa | |
| Romania | Clinicile ICCO | Brasov | |
| Romania | Centrele de Exelenta ARES | Constanta | |
| Romania | Spitalul Judetean de Urgenta Sibiu | Sibiu | |
| Romania | Cordismed SRL | Timisoara | |
| Saudi Arabia | Prince Abdullah Bin Abdulaziz Cardiac Center | North Region Arar KSA | |
| Saudi Arabia | Dallah Hospital | Riyadh | |
| Serbia | Cardiology Clinic, Clinical Centre of Serbia | Belgrade | |
| Serbia | Cardiovascular Institute Dedinje | Belgrade | |
| Serbia | CHC Bezanijska kosa | Belgrade | |
| Serbia | KBC Zvezdara | Belgrade | |
| Serbia | Clinical Center Kragujevac | Kragujevac | |
| Serbia | Institute of cardiovascular diseases Vojvodina | Sremska Kamenica | |
| Slovakia | Stredodlovensky Ustav Srdcovych A Cievnych Chorob | Banská Bystrica | |
| South Africa | Dr JCW Badenhorst - Netcare Unitas Hospital | Centurion | |
| South Africa | Unitas Hospital | Centurion | |
| South Africa | Unitas Hospital - Dr. Ebrahim | Centurion | |
| South Africa | Milpark Hospital | Johannesburg | |
| South Africa | Netcare Union Hospital | Johannesburg | |
| South Africa | Ethekwini Hospital & Heart centre | Newlands | |
| South Africa | Netcare Greenacres Hospital | Port Elizabeth | |
| South Africa | Netcare Unitas Hospital | Pretoria | |
| Spain | Hospital general de Albacete | Albacete | |
| Spain | Hospital General de Alicante | Alicante | |
| Spain | Hospital Infanta Cristina - Badajoz | Badajoz | |
| Spain | Hospital G. Trias i Pujol (Badalona) | Badalona | |
| Spain | Hospital de Cruces-Barakaldo | Barakaldo | |
| Spain | Bellvitge University Hospital | Barcelona | |
| Spain | Hospital del Mar | Barcelona | |
| Spain | Hospital Sant Pau (Barcelona) | Barcelona | |
| Spain | Hospital V. Hebrón | Barcelona | |
| Spain | Hospital Vall d'Hebron | Barcelona | |
| Spain | Hospital de Galdakano | Bizkaia | |
| Spain | Hospital General Universitario de Burgos | Burgos | |
| Spain | Hospital San Pedro de Alcantara-Caceres | Caceres | |
| Spain | Hospital Santa Lucia de Cartagena | Cartagena | |
| Spain | Universitario Santa Lucia (Hospital Nostra Señora Rossell) (Cartagena) | Cartagena | |
| Spain | Hospital Santa Lucia de Cartagena | Cartagena (Murcia) | |
| Spain | Hospital General Castellón | Castellón | |
| Spain | Hospital General Ciudad Real | Ciudad Real | |
| Spain | Hospital de la Cruz Roja de Córdoba | Córdoba | |
| Spain | Hospital Reina Sofia de Córdoba | Córdoba | |
| Spain | Hospital de Galdakao | Galdakao | |
| Spain | Hospital Cabueñes (Gijón) | Gijón | |
| Spain | Hospital Universitario de Guadalajara | Guadalajara | |
| Spain | Hospital Juan Ramón Jiménez | Huelva | |
| Spain | Complexo Hospitalario Universitario A Coruña (CHUAC) | La Coruña | |
| Spain | Hospital San Rafael (La Coruña) | La Coruña | |
| Spain | Hosp Universitario de Gran Canaria Dr. Negrin | Las Palmas De Gran Canaria | |
| Spain | Hospital de León | León | |
| Spain | Hospital San Pedro | Logroño | |
| Spain | Hospital San Pedro (Logroño - La Rioja) | Logroño | |
| Spain | Hospital Universitario Lucus Augusti (HULA) | Lugo | |
| Spain | Clinica La Luz | Madrid | |
| Spain | Clínica San Fransisco de Asis (Madrid) | Madrid | |
| Spain | Hospital 12 Octubre | Madrid | |
| Spain | Hospital Fundacion Alcorcon | Madrid | |
| Spain | Hospital La Luz | Madrid | |
| Spain | Hospital Moncloa | Madrid | |
| Spain | Hospital Moncloa (Madrid) | Madrid | |
| Spain | Hospital Puerta de Hierro (Madrid) | Majadahonda | |
| Spain | Hospital Manises (Valencia) | Manises | |
| Spain | Hospital de Mérida | Mérida | |
| Spain | Hospital Virgen Arrixaca (Murcia) | Murcia | |
| Spain | Universitario central de Asturias | Oviedo | |
| Spain | Universitario central de Asturias (Oviedo) | Oviedo | |
| Spain | Hospital de Navarra | Pamplona | |
| Spain | San Juan de Alicante | San Juan | |
| Spain | Hospital de Donostia | San Sebastián | |
| Spain | Hospital Universitario Donostia | San Sebastián | |
| Spain | Hospital Marqués de Valdecilla | Santander | |
| Spain | Hospital Marqués de Valdecilla, Santander | Santander | |
| Spain | Hospital Clínico Universitario de Santiago de Compostela | Santiago de Compostela | |
| Spain | Hospital Virgen De La Salud | Toledo | |
| Spain | Hospital Virgen De La Salud (Toledo) | Toledo | |
| Spain | Clínico Universitario Valencia | Valencia | |
| Spain | Instituto Cardiologico Hospital Campo Grande | Valladolid | |
| Spain | Instituto Cardiologico Hospital Campo Grande (Valladolid) | Valladolid | |
| Spain | Hospital Meixoeiro-MEDTEC (Vigo) | Vigo | |
| Spain | Hospital Txagorritxu | Vitoria | |
| Spain | Hospital Clínico Lozano Blesa de Zaragoza | Zaragoza | |
| Spain | Hospital Universitario Miguel Servet | Zaragoza | |
| Sweden | Gavle Sjukhus | Gavle | |
| Sweden | Malarsjukshuet | Malarsjukhuset | |
| Sweden | sjukhuset Orebro | Orebro | |
| Sweden | Universitets Sjukhuset I Örebro | Örebro | |
| Sweden | Skaraborgs Sjukhus | Skovde | |
| Sweden | Skaraborgs sjukhus v Skövde | Skövde | |
| Sweden | Sundvalls Sjukhus | Sundvalls | |
| Sweden | Vastmanlads Sjukhus | Vasteras | |
| Sweden | Västmanlads sjukhus Västerås | Västerås | |
| Switzerland | Spital Thurgau AG | Frauenfeld | |
| Switzerland | Hopitaux Universitaires de Genève | Genève | |
| Switzerland | Kantonsspital Baselland | Liestal | |
| Switzerland | Cardiocenter Lugano, Ticino (TI) | Lugano | |
| Switzerland | Cardiocentro Ticino | Lugano | |
| Switzerland | Kantonsspital Luzern | Luzern | |
| Switzerland | La Tour Hospital | Meyrin Geneva | |
| Switzerland | HerzGefässZentrum | Zürich | |
| Switzerland | HerzGefässZentrum Zürich | Zürich | |
| Thailand | Paolo Memorial Hospital Phaholyothin | Bangkok | |
| Thailand | Police General Hospital | Bangkok | |
| Thailand | Ramkhamhaeng Hospital | Bangkok | |
| Thailand | HRH Princess Maha Chakri Siridhorn Medical Center | Nakhon Navok | |
| Thailand | HRH Princess Maha Chakri Sirindhorn Medical Center (Nakornayok) | Nakhon Navok | |
| Thailand | Central Chest Institute of Thailand | Nonthaburi | |
| Thailand | Phatara Thonburi Hospital | Pathum Thani | |
| Thailand | Udonthani HP. | Udon Thani | |
| Thailand | Udonthani Hospital | Udonthani | |
| Tunisia | Clinique Hannibal Lac 2_Dr. Mohamed Drissa | El Mourouj | |
| Tunisia | Clinique Générale et Cardiovasculaire de Tunis_Dr. Sami Bouziri | La Marsa | |
| Tunisia | Bassatine Clinic_Dr. Elyes Kharrat | Sfax | |
| Tunisia | Polyclinique Bassatine Cite gardin Sfax_Dr. Zeineb Grati Guermazi | Sfax | |
| Tunisia | Polyclinique El Bassatine SFAX_Dr. Sami Fourati | Sfax | |
| Tunisia | Polyclinique El bassatine_Dr. Mohamed Najeh Abid | Sfax | |
| Tunisia | Polyclinique El Bassatine_Dr. Ridha Ennouri | Sfax | |
| Tunisia | Centre Urbain Nord_Dr. Salem Abdessalem | Tunis | |
| Tunisia | Clinique Cartagène_Dr. Dhaker Lahidheb | Tunis | |
| Tunisia | Clinique Général et Cardiovasculaire de Tunis_Dr. Saloua Trabelsi | Tunis | |
| Tunisia | Clinique Générale et Cardiovasculaire de Tunis_Dr. Saloua TRABELSI | Tunis | |
| Tunisia | Clinique Hannibal Lac 2_Gharbi Mostari | Tunis | |
| Tunisia | Clinique Montplaisir_Dr. Badi Darghouth | Tunis | |
| Tunisia | HU Mohamed Taher El Maâmouri | Tunis | |
| Tunisia | Policlinique Taoufik_Jamel Langar | Tunis | |
| Tunisia | Soukra Medical_Dr. Ben Chedli Tarek | Tunis | |
| Ukraine | Heart Institute | Kiev | |
| Ukraine | Institute of Heart (Ministry of Health) | Kiev | |
| Ukraine | NAMS Amosov | Emergency Endovascular Surgery department | Kiev | |
| Ukraine | NAMS Amosov | X-Ray diagnostics and invasive cardiology department | Kiev | |
| Ukraine | National Institute of Cardiovascular Surgery NAMS | Kiev | |
| Ukraine | National Institute of Surgery and Transplantology NAMS | Kiev | |
| Ukraine | S.P.M.C. of Pediatric Cardiology and Cardiac Surgery | Kiev | |
| Ukraine | Strazhesko Institute of Cardiology (National Scientific Centre) | Kiev | |
| Ukraine | Government institution Regional centre of cardiac and vessel disease | Zaporizhzhya | |
| United Arab Emirates | Al Noor Hospital-Airport Rd. | Abu Dhabi | |
| United Arab Emirates | LifeCare Hospital | Abu Dhabi | |
| United Arab Emirates | Al Zahra Private hospital, Dubai | Dubai | |
| United Arab Emirates | Belhoul Speciality Hospital | Dubai | |
| United Arab Emirates | Dr. Sulaiman Al Habib Hospital | Dubai | |
| United Arab Emirates | Dubai Hospital | Dubai | |
| United Arab Emirates | Iranian hospital | Dubai | |
| United Arab Emirates | Prime Hospital | Dubai | |
| United Arab Emirates | Rashid Hospital | Dubai | |
| United Arab Emirates | Al Qassimi Hopsital | Sharja | |
| United Kingdom | Essex Cardiothoracic centre | Basildon | |
| United Kingdom | Royal United Hospital, Bath | Bath | |
| United Kingdom | Bedford Hospital | Bedford | |
| United Kingdom | Queen Elizabeth Hospital | Birmingham | |
| United Kingdom | Sandwell and West Birmingham Hospitals | Birmingham | |
| United Kingdom | Royal Blackburn Hospital | Blackburn | |
| United Kingdom | Blackpool Victoria Hospital | Blackpool | |
| United Kingdom | Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust | Bournemouth | |
| United Kingdom | Bradford teaching hospitals | Bradford | |
| United Kingdom | Royal Sussex Hospital, Brighton | Brighton | |
| United Kingdom | University Hospital Wales | Cardiff | |
| United Kingdom | Royal Brompton and Harefield | Chelsea | London |
| United Kingdom | Croydon University Hospital | Croydon | |
| United Kingdom | Royal Derby Hospital | Derby | |
| United Kingdom | Dorset County Hospital | Dorchester | |
| United Kingdom | Eastbourne and Conquest Hospitals | Eastbourne | |
| United Kingdom | Freeman Hospital | Freeman | |
| United Kingdom | West Middlesex Hospital | Isleworth | |
| United Kingdom | Kettering General Hospital | Kettering | |
| United Kingdom | University Hospitals of Leicester | Leicester | |
| United Kingdom | Lincoln County Hospital | Lincoln | |
| United Kingdom | Royal Free Hospital | London | |
| United Kingdom | The Royal Free Hospital | London | |
| United Kingdom | University Hospital of South Manchester | Manchester | |
| United Kingdom | James Cook University Hospital | Middlesbrough | |
| United Kingdom | Wolverhampton | New Cross | |
| United Kingdom | Royal Gwent Hospital, Newport | Newport | |
| United Kingdom | Northwick Park Hospital | Northwick Park | |
| United Kingdom | Norfolk and Norwich University Hospital | Norwich | |
| United Kingdom | Nottingham University Hospitals - Queen's Medical Centre | Nottingham | |
| United Kingdom | Queens medical center Nottingham | Nottingham | |
| United Kingdom | Bircham Park Offices Plymouth | Plymouth | |
| United Kingdom | Plymouth Hospital | Plymouth | |
| United Kingdom | Royal Berkshire | Reading | |
| United Kingdom | Salisbury District Hospital | Salisbury | |
| United Kingdom | Sheffield teaching hospital | Sheffield | |
| United Kingdom | Lister Hospital, Stevenage | Stevenage | |
| United Kingdom | Royal Stoke University Hospital | Stoke-on-Trent | |
| United Kingdom | King's Mill Hospital | Sutton in Ashfield | |
| United Kingdom | Royal Cornwall Hospitals | Truro | |
| United Kingdom | Tunbridge Wells Hospital | Tunbridge Wells | |
| United Kingdom | Coventry and Warwickshire | Walsgrave | |
| United Kingdom | Wrightington Hospital | Wigan | |
| United Kingdom | Worcestershire Acute Hospitals | Worcestershire | |
| United Kingdom | Worthing Hospital, West Sussex | Worthing | |
| United Kingdom | Buckinghamshire, Wycombe | Wycombe | |
| Uzbekistan | Republic Specialized Center of Surgery | Tashkent | |
| Vietnam | Thong Nhat Hospital | Hò Chi Minh City |
| Lead Sponsor | Collaborator |
|---|---|
| Terumo Europe N.V. |
Argentina, Armenia, Austria, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Chile, Colombia, Czechia, Egypt, Estonia, France, Georgia, Hungary, Iceland, India, Indonesia, Ireland, Israel, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Morocco, Netherlands, North Macedonia, Oman, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | TLF | Target Lesion Failure defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically drive target lesion revascularization (TLR) at 1 year. | 1 year | |
| Secondary | success endpoints | Procedural success and Device success | 3 months and 1 year | |
| Secondary | safety endpoints | cardiac death / mi (peri and post procedural) stent thrombosis (according to ARC definitions) acute/subacute/late primary/secondary Composite endpoint of cardiac death and post procedural MI Composite endpoint of cardiac death , post procedural MI and stent thrombosis rate during the course of DAPT versus the same events after cessaton of DAPT Major vascular and bleeding complications | 3months and 1 year | |
| Secondary | efficacy and patient oriented (composite) endpoints | TLR rate (re-pci/CABG) TLF rate Target Vessel Failure rate (TVF) defined as target vessel revascularization target vessel related q-wave or non q-wave myocardial infarction, or cardiax death that could ot be clearly attributed to a veessl other than the target vessel Patient oriented composite endpoint (POCE) defined as any cause of mortality, mi (q-wave and non qwave) or any TVR | 3months and 1 year |
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