e-Ultimaster: Prospective, Single-arm, Multi Centre Observations Ultimaster Des Registry
Sponsor
Terumo Europe N.V. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02188355
Collaborator
(none)
37,000
462
72
80.1
1.1
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
All consecutive patients suitable for treatment with DES according to hospital routine practice in centres across the world that agree to participate in the e-ULTIMASTER registry will be treated with Ultimaster DES.
Secondary objectives Evaluation of worldwide utilization of DES, Detection of rare events in representative patient population, identification of predictors of major advers events, assessment of radial access site utilization and its impact on bleeding and vascular complications, assessment of procedural particularities and patients pathology in wide geographic area, assessment of duration and type of DAPT, assesment of the performace of Ultimaster DES is patients lesions subsets, assessment of possible benefits of biodegradable polymer in lager complex patiets/lesions subset and assessment of sirolimus efficacy in different races.
Data will be collected in a e-CRF and online monitoring will be done. Audits will be allowed by sponsor or qualified designees.
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
37000 participants
Observational Model:
Other
Time Perspective:
Prospective
Official 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
Actual Study Start Date
:
Jun 1, 2014
Anticipated Primary Completion Date
:
Jun 1, 2020
Anticipated Study Completion Date
:
Jun 1, 2020
Outcome Measures
Primary Outcome Measures
- TLF [1 year]
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.
Secondary Outcome Measures
- success endpoints [3 months and 1 year]
Procedural success and Device success
- safety endpoints [3months and 1 year]
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
- efficacy and patient oriented (composite) endpoints [3months and 1 year]
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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fundación Favaloro | Buenos Aires | Argentina | ||
| 2 | Hospital San Juan de Dios | Buenos Aires | Argentina | ||
| 3 | Hospital Universitario Austral | Buenos Aires | Argentina | ||
| 4 | Instituto Cardiovascular de Buenos Aires | CABA - Buenos Aires | Argentina | ||
| 5 | Clinica Centro Médico Privado Junin | Junin | Argentina | ||
| 6 | Clinica Monte Grande | Monte Grande | Argentina | ||
| 7 | Instituto Cardiovascular de Rosario | Rosario | Argentina | ||
| 8 | Sanatorio San Miguel | San Miguel | Argentina | ||
| 9 | Medical center Gyumri CJSC | Gyumri | Armenia | 3103 | |
| 10 | "QANCOR" cardiovascular MC LLC | Yerevan | Armenia | ||
| 11 | Astghik Medical Center (Natali Farm) | Yerevan | Armenia | ||
| 12 | QANCOR Cardiovascular MC LLC | Yerevan | Armenia | ||
| 13 | Republican Medical Center Armenia CJSC | Yerevan | Armenia | ||
| 14 | Yerevan State medical University Hospital | Yerevan | Armenia | ||
| 15 | Medizinische Universität Graz | Graz | Austria | ||
| 16 | AKh Linz | Linz | Austria | ||
| 17 | Hanusch Krankenhaus der Wiener Gebietskrankenkasse | Vienna | Austria | ||
| 18 | Krankenanstalt Rudolfstiftung der Stadt Wien | Vienna | Austria | ||
| 19 | Vienna General Hospital | Vienna | Austria | ||
| 20 | National Heart Foundation Hospital and Research Institute | Dhakuli | Bangladesh | ||
| 21 | City Clinical Emergency Hospital | Minsk | Belarus | ||
| 22 | RSPC | Minsk | Belarus | ||
| 23 | OLVZ Aalst, Onze Lieve Vrouw Ziekenhuis vzw-Campus Aalst | Aalst | Belgium | ||
| 24 | Olvz Aalst | Aalst | Belgium | ||
| 25 | Imelda Ziekenhuis - Bonheiden | Bonheiden | Belgium | ||
| 26 | Imelda Ziekenhuis | Bonheiden | Belgium | ||
| 27 | Cliniques Saint-Luc | Brussels | Belgium | ||
| 28 | CHU Charleroi | Charleroi | Belgium | ||
| 29 | AZ Sint Lucas | Gent | Belgium | ||
| 30 | Epicura-Hornu | Hornu | Belgium | ||
| 31 | Jan Yperman Ziekenhuis | Ieper | Belgium | ||
| 32 | CHR de la Citadelle | Liège | Belgium | ||
| 33 | Hôpital Ambroise Paré de Mons | Mons | Belgium | ||
| 34 | CHU UCL Mont Godinne Namur | Yvoir | Belgium | ||
| 35 | Hospital Felicio Rocho | Belo Horizonte | Brazil | ||
| 36 | Unimed Joinville | Joinville | Brazil | ||
| 37 | Hospital Monte Sinai | Juiz De Fora | Brazil | ||
| 38 | UNICOR | Linhares | Brazil | ||
| 39 | Paraná Medical Research Center | Maringá | Brazil | ||
| 40 | Eurolatino Natal Medical Research | Natal | Brazil | ||
| 41 | Hospital São Vicente de Paulo | Passo Fundo | Brazil | ||
| 42 | Hospital Moinhos de Vento | Porto Alegre | Brazil | ||
| 43 | Hospital e Maternidade Dr. Christóvão da Gama | Santo André | Brazil | ||
| 44 | Beneficência Portuguesa de São Paulo | São Paulo | Brazil | ||
| 45 | Hospital Santa Cruz | São Paulo | Brazil | ||
| 46 | "Mhat Puls" Ad | Blagoevgrad | Bulgaria | ||
| 47 | City clinic Burgas | Burgas | Bulgaria | ||
| 48 | MBAL Haskovo AD | Haskovo | Bulgaria | ||
| 49 | Cardiolife-Lovech | Lovech | Bulgaria | ||
| 50 | Mbal Montana City Clinic Sveti Georgi | Montana | Bulgaria | ||
| 51 | MBAL St. Karidad | Plovdiv | Bulgaria | ||
| 52 | MHAT Plovdiv | Plovdiv | Bulgaria | ||
| 53 | University Hospital Sveti Georgi | Plovdiv | Bulgaria | ||
| 54 | City clinic University Multi-Profile Hospital for Acute Care,Sofia | Sofia | Bulgaria | ||
| 55 | MBAZ-II-Sofia | Sofia | Bulgaria | ||
| 56 | MHATEM N.I.Pirogov | Sofia | Bulgaria | ||
| 57 | National Heart Hospital | Sofia | Bulgaria | ||
| 58 | Tokuda Hospital | Sofia | Bulgaria | ||
| 59 | UMHAT Alexandrovska | Sofia | Bulgaria | ||
| 60 | UMHAT St.Ekaterina | Sofia | Bulgaria | ||
| 61 | Trakiya Hospital | Stara Zagora | Bulgaria | ||
| 62 | Umbal Stojan Kirkovich | Stara Zagora | Bulgaria | ||
| 63 | Specialized Cardiology Hospital for Active Treatment | Varna | Bulgaria | ||
| 64 | MBAL Sveta Petka Vidin | Vidin | Bulgaria | ||
| 65 | Hospital Antofagasta | Antofagasta | Chile | ||
| 66 | Hospital Guillermo Grant Benavente | Concepcion | Chile | ||
| 67 | Hospital Regional Puerto Montt | Puerto Montt | Chile | ||
| 68 | Clinica Bicentenario | Region Metropolitana | Chile | ||
| 69 | Clinica Santa Maria | Santiago | Chile | ||
| 70 | Hospital San Borja Arriaran | Santiago | Chile | ||
| 71 | Hospital San Juan de Dios | Santiago | Chile | ||
| 72 | Hospital Van Buren | Valparaíso | Chile | ||
| 73 | Clinica Marly | Bogota | Colombia | ||
| 74 | Clinica Shaio | Bogota | Colombia | ||
| 75 | Fundación Cardiovascular de Colombia | Bucaramanga | Colombia | ||
| 76 | Instituto del corazón de Bucaramanga | Bucaramanga | Colombia | ||
| 77 | Centro Cardiovascular de Caldas | Manizales | Colombia | ||
| 78 | FNKV | Prag | Srobarova | Czechia | |
| 79 | Fakultni nemocnice u svate Anny v Brne | Brno | Czechia | ||
| 80 | Karlovarská Krajská nemocnice | Karlovy Vary | Czechia | ||
| 81 | Kardiologie na Bulovce | Prague | Czechia | ||
| 82 | Krajska nemocnice t. Bati | Zlín | Czechia | ||
| 83 | Police Hospital | Alexandria | Egypt | ||
| 84 | Al Hayat Hospital | Cairo | Egypt | ||
| 85 | Al Nakheel Hospital | Cairo | Egypt | ||
| 86 | Dr Ahmed Abdel Aziz Multicenter | Cairo | Egypt | ||
| 87 | Dr Hisham Ammar Multicenter | Cairo | Egypt | ||
| 88 | Dr Hussien Heshmat - As Salam International Hospital | Cairo | Egypt | ||
| 89 | Dr. Tarek Rashid | Cairo | Egypt | ||
| 90 | Dr.Hazem Al Guindi | Cairo | Egypt | ||
| 91 | El Marwa Hospital | Cairo | Egypt | ||
| 92 | Italian Hospital | Cairo | Egypt | ||
| 93 | Nile Badrawy Hospital | Cairo | Egypt | ||
| 94 | Sheraton Hospital for Medical Services | Cairo | Egypt | ||
| 95 | Wadi El Neel Hospital | Cairo | Egypt | ||
| 96 | Um El Korra Hospital | El Gharbeya | Egypt | ||
| 97 | L-Fouad Cardiac Center | Menofia | Egypt | ||
| 98 | East-Tallinn Central Hospital | Tallinn | Estonia | ||
| 99 | North Estonia Medical Center | Tallinn | Estonia | ||
| 100 | CHU Angers | Angers | France | ||
| 101 | Hopital Européen de Paris La Roseraie | Aubervilliers | France | ||
| 102 | Clinique Rhône Durance | Avignon | France | ||
| 103 | GCS Cardiologique de Bayonne | Bayonne | France | ||
| 104 | Clinique St Augustin Bordeaux-Centre d'exploration-chirurgie | Bordeaux | France | ||
| 105 | CHU Caen | Caen | France | ||
| 106 | Hopital Privé Saint Martin | Caen | France | ||
| 107 | CHU Clermont-Ferrand | Clermont-Ferrand | France | ||
| 108 | Pôle Santé République Clermont Ferrand | Clermont-Ferrand | France | ||
| 109 | Hopital Albert Schweitzer GHCA Colmar | Colmar | France | ||
| 110 | CH Sud Francilien | Corbeil Essonnes | France | ||
| 111 | Clinique de Fontaine | Dijon | France | ||
| 112 | Groupement mutualiste de Grenoble | Grenoble | France | ||
| 113 | CH Haguenau | Haguenau | France | ||
| 114 | CH de Marne la Vallée | Jossigny | France | ||
| 115 | CHD Vendée La Roche sur Yon | La Roche sur Yon | France | ||
| 116 | Groupe Hospitalier de la Rochelle Ré Aunis | La Rochelle | France | ||
| 117 | CH Louis Pasteur-Le Coudray | Le Coudray | France | ||
| 118 | Hopital privé La Louviere-Lille | Lille | France | ||
| 119 | CH St Joseph St Luc Lyon | Lyon | France | ||
| 120 | Hopital Privé Jacques Cartier Massy | Massy | France | ||
| 121 | Clinique du Pont de Chaume Montauban | Montauban | France | ||
| 122 | Clinique du Milénaire | Montpellier | France | ||
| 123 | CH Montreuil | Montreuil | France | ||
| 124 | Clinique Diaconat Fonderie Mulhouse | Mulhouse | France | ||
| 125 | Clinique Louis Pasteur Essey les Nancy | Nancy | France | ||
| 126 | Le Confluent Nouvelles Cliniques Nantaises | Nantes | France | ||
| 127 | Clinique Ambroise Paré | Neuilly Sur Seine | France | ||
| 128 | Polyclinique les Fleurs | Ollioules | France | ||
| 129 | CHR Orléans | Orléans | France | ||
| 130 | Groupe Hopitalier Paris Saint Joseph | Paris | France | ||
| 131 | Centre Hospitalier de Pau | Pau | France | ||
| 132 | Hopital privé St Martin Pessac (DR Levy) | Pessac | France | ||
| 133 | Hôpital Privé St Martin de Pessac | Pessac | France | ||
| 134 | CHU de Poitiers | Poitiers | France | ||
| 135 | CH René Dubos Pontoise | Pontoise | France | ||
| 136 | CHIC Quimper | Quimper | France | ||
| 137 | Hopiatl Privé Claude Galien Quincy | Quincy sous sénart | France | ||
| 138 | Clinique Saint-Laurent Rennes | Rennes | France | ||
| 139 | Clinique ST Hilaire Rouen | Rouen | France | ||
| 140 | CH Yves le Foll - Saint Brieuc | Saint Brieuc | France | ||
| 141 | CH La Timone Marseille | Saint Pierre | France | ||
| 142 | CH Général de Saint Quentin | Saint-Quentin | France | ||
| 143 | Institut Arnault Tzanck St Laurent du Var | St Laurent du Var | France | ||
| 144 | Nouvel Hopital Civil de Strasbourg | Strasbourg | France | ||
| 145 | Clinique Saint Joseph | Trélazé | France | ||
| 146 | CH de Valence | Valence | France | ||
| 147 | CH Bretagne Atlantique | Vannes | France | ||
| 148 | Diagnostic Services Ltd. Cardio Clinic | Tbilisi | Georgia | ||
| 149 | Helsicore Clinic | Tbilisi | Georgia | ||
| 150 | JoAnn Medical Center | Tbilisi | Georgia | ||
| 151 | Semmelweis University | Budapest | Hungary | ||
| 152 | Hospital Pándy Kálmán | Gyula | Hungary | ||
| 153 | Moritz Kaposi General Hospital | Kaposvár | Hungary | ||
| 154 | Szatmar-Szabolcs-Bereg county hospital and university teaching hospital | Nyíregyháza | Hungary | ||
| 155 | Pecs University | Pecs | Hungary | ||
| 156 | Markusovszky University Teaching Hospital | Szombathely | Hungary | ||
| 157 | Landspitali National University hospital | Reykjavik | Iceland | ||
| 158 | Kamalnayan Bajaj Hospital | Aurangabad | India | ||
| 159 | MMM, Chennai | Chennai | India | ||
| 160 | G. Kuppuswamy Naidu Memorial Hospital (GKNM), Coimbatore | Coimbatore | India | ||
| 161 | Medanta Hospital, Delhi | Delhi | India | ||
| 162 | Care Hospital, Hyderabad | Hyderabad | India | ||
| 163 | SMS Hospital, Jaipur | Jaipur | India | ||
| 164 | BM Birla, Kolkata | Kolkata | India | ||
| 165 | KMC, Mangalore | Mangalore | India | ||
| 166 | Fortis Hospital, Mohali | Mohali | India | ||
| 167 | H.J. Doshi Ghatkopar Hindusabha Hospital | Mumbai | India | ||
| 168 | Hiranandani Hospital, Mumbai | Mumbai | India | ||
| 169 | Wockhardt Hospital, Nagpur | Nagpur | India | ||
| 170 | Maharaja Agrasen Hospital, New Delhi | New Delhi | India | ||
| 171 | Max Super Speciality Hospital, Saket, Delhi | New Delhi | India | ||
| 172 | SCTIT, Trivanderum | Trivanderum | India | ||
| 173 | National Cardiovascular Center Harapan Kita | Jakarta Barat | Indonesia | ||
| 174 | RSUPN Cipto Mangunkusumo | Jakarta Pusat | Indonesia | ||
| 175 | RSUP Fatmawati General Hospital | Jakarta Selatan | Indonesia | ||
| 176 | Binawaluya Cardiac Center | Jakarta Timur | Indonesia | ||
| 177 | Medistra Hospital | Jakarta | Indonesia | ||
| 178 | Awal Bros Hospital | Makassar | Indonesia | ||
| 179 | Dr. Wahidin Sudirohusodo General Hospital | Makassar | Indonesia | ||
| 180 | Saiful Anwar Hospital | Malang | Indonesia | ||
| 181 | Dr. Soetomo General Hospital | Surabaya | Indonesia | ||
| 182 | Cork University Hospital | Cork | Ireland | ||
| 183 | University Hospital Galway | Galway | Ireland | ||
| 184 | University Hospital Limerick | Limerick | Ireland | ||
| 185 | Rambam Medical Center | Haifa | Israel | ||
| 186 | Galilee Medical Center | Nahariya | Israel | ||
| 187 | Assaf Harofeh Medical Center | Tzrifin | Israel | ||
| 188 | Ziv M.C | Zefat | Israel | ||
| 189 | Kansai Rosai Hospital | Amagasaki Hyougo | Japan | ||
| 190 | Kokura Memorial Hospital | Fukuoka | Japan | ||
| 191 | Iwaki Kyoritsu General Hospital | Fukushima | Japan | ||
| 192 | Tokai University Hachiouji Hospital | Hachiōji | Japan | ||
| 193 | Hakodate Municipal Hospital | Hakodate Hokkaido | Japan | ||
| 194 | Seirei Hamamatsu General Hospital | Hamamatsu | Japan | ||
| 195 | Kakogawa East City Hospital | Kakogawa | Japan | ||
| 196 | Shonan Kamakura General Hospital | Kanagawa | Japan | ||
| 197 | Komaki City Hospital | Komaki Aichi | Japan | ||
| 198 | Kyoto Katsura Hospital | Kyoto | Japan | ||
| 199 | Gunma Prefectural Cardiovascular Center | Maebashi | Japan | ||
| 200 | Mie Heart Center | Mie | Japan | ||
| 201 | Osaka General Medical Center | Osaka | Japan | ||
| 202 | Sakurabashi Watanabe Hospital | Osaka | Japan | ||
| 203 | Saitama Cardiovascular and Respiratory Center | Saitama | Japan | ||
| 204 | Osaka Rosai Hospital | Sakai Osaka | Japan | ||
| 205 | Mimihara General Hospital | Sakai | Japan | ||
| 206 | Sapporo Higashi Tokushukai Hospital | Sapporo Hokkaido | Japan | ||
| 207 | Saiseikai Senri Hospital | Suita | Japan | ||
| 208 | Okamura Memorial Hospital | Suntougun Shizuoka | Japan | ||
| 209 | Higashi Takarazuka Satoh Hospital | Takarazuka Hyougo | Japan | ||
| 210 | Kouseikai Takai Hospital | Tennri Nara | Japan | ||
| 211 | Saiseikai Yamaguchi General Hospital | Yamaguchi | Japan | ||
| 212 | Showa University Fujigaoka Hospital | Yokohama Kanagawa | Japan | ||
| 213 | Saiseikai Yokohama City Eastern Hospital | Yokohama | Japan | ||
| 214 | Seirei Yokohama Hospital | Yokohama | Japan | ||
| 215 | Jordan Hospital | Amman | Jordan | ||
| 216 | Aktobe Regional Hospital | Aktobe | Kazakhstan | ||
| 217 | Medical University Clinic West Kazakhstan | Aktobe | Kazakhstan | ||
| 218 | Almaty city cardio center | Almaty | Kazakhstan | ||
| 219 | National Surgery Center Almat | Almaty | Kazakhstan | ||
| 220 | City Hospital #2 | Astana | Kazakhstan | ||
| 221 | JSC Nat. Scient. Cardiosurgery Ctr. | Astana | Kazakhstan | ||
| 222 | National Scientific Medical Research Center JSC | Astana | Kazakhstan | ||
| 223 | Regional Cardiosurgery Center | Karaganda | Kazakhstan | ||
| 224 | Karagandy Regional Cardiac Center | Karagandy | Kazakhstan | ||
| 225 | Akmola Regional Hospital | Kokshetau | Kazakhstan | ||
| 226 | Pavlodar Regional Cardiologic center | Pavlodar | Kazakhstan | ||
| 227 | Cardiology Center Petropavl | Petropavl | Kazakhstan | ||
| 228 | Rudnyi City Hospital | Rudnyi | Kazakhstan | ||
| 229 | University Hospital of Semey | Semey | Kazakhstan | ||
| 230 | Shymkent Regional Cardiology Center | Shymkent | Kazakhstan | ||
| 231 | Clinical Center of Cardiac Surgery and Transplantation | Taraz | Kazakhstan | ||
| 232 | Sabah Al Ahmad Cardiac Center | Kuwait | Kuwait | ||
| 233 | Hopital Abou Jaoudé | Beirut | Lebanon | ||
| 234 | Labib Medical Center | Sidon | Lebanon | ||
| 235 | LSMU Kauno Klinikos | Kaunas | Lithuania | ||
| 236 | Klaipeda Seamen's Hospital | Klaipėda | Lithuania | ||
| 237 | Hospital Sultanah Bahiyah | Alor Setar, Kedah | Malaysia | ||
| 238 | Hospital Serdang | Kajang | Malaysia | ||
| 239 | Desa Park City | Kuala Lumpur | Malaysia | ||
| 240 | HSC Medical Center | Kuala Lumpur | Malaysia | ||
| 241 | Hospital Tengku Ampuan Afzan | Kuantan | Malaysia | ||
| 242 | UiTM Sg. Buloh Campus | Sungai Buloh | Malaysia | ||
| 243 | Fray Juan de San Miguel | Michoacan | Mexico | ||
| 244 | Clinica Hospital San Jose de Navojoa SA de CV | Sonora | Mexico | ||
| 245 | Hospital Star Médica Merida | Yucatán | Mexico | ||
| 246 | Clinique Achifaa de Casablanca | Casablanca | Morocco | ||
| 247 | CLINIQUE INTERNATIONALE de Marrakech | Marrakech | Morocco | ||
| 248 | Clinique Grant Atlas | Marrakesh | Morocco | ||
| 249 | Cherradi_Clinique Agdal | Rabat | Morocco | ||
| 250 | Meander Amersfoort | Amersfoort | Netherlands | ||
| 251 | Rijnstate | Arnhem | Netherlands | ||
| 252 | Amphia Ziekenhuis | Breda | Netherlands | ||
| 253 | Jeroen Bosch Ziekenhuis | Den Bosch | Netherlands | ||
| 254 | Medisch Centrum Haaglanden | Den Haag | Netherlands | ||
| 255 | Albert Schweitzer Ziekenhuis | Dordrecht | Netherlands | ||
| 256 | Catharina Hospital | Eindhoven | Netherlands | ||
| 257 | Catharina Ziekenhuis | Eindhoven | Netherlands | ||
| 258 | Scheper Ziekenhuis | Emmen | Netherlands | ||
| 259 | Medisch Spectrum Twente | Enschede | Netherlands | ||
| 260 | Medisch Centrum Leeuwarden | Leeuwarden | Netherlands | ||
| 261 | Maasstad Ziekenhuis | Rotterdam | Netherlands | ||
| 262 | Zorgzaam Ziekenhuis Zeeuws-Vlaanderen | Terneuzen | Netherlands | ||
| 263 | VieCuri Medical Centre | Venlo | Netherlands | ||
| 264 | City General Hospital 8th September Skopje | Skopje | North Macedonia | ||
| 265 | University Clinic of Cardiology | Skopje | North Macedonia | ||
| 266 | Muscat Private Hospital | Muscat | Oman | ||
| 267 | Miedziowe Centrum Zdrowia | Lubin | Poland | ||
| 268 | Szpital Kliniczny Przemienienia Panskiego UM im. K. Marcinkowskiego w Poznaniu | Poznan | Poland | ||
| 269 | Infant Jesus Teaching Hospital | Warsaw | Poland | ||
| 270 | Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego | Warsaw | Poland | ||
| 271 | Hospital Santa María | Lisboa | Portugal | ||
| 272 | Clinicile ICCO | Braşov | Romania | ||
| 273 | Centrele de Exelenta ARES | Constanţa | Romania | ||
| 274 | Spitalul Judetean de Urgenta Sibiu | Sibiu | Romania | ||
| 275 | Cordismed SRL | Timisoara | Romania | ||
| 276 | Prince Abdullah Bin Abdulaziz Cardiac Center | North Region Arar KSA | Saudi Arabia | ||
| 277 | Dallah Hospital | Riyadh | Saudi Arabia | ||
| 278 | Cardiology Clinic, Clinical Centre of Serbia | Belgrade | Serbia | ||
| 279 | Cardiovascular Institute Dedinje | Belgrade | Serbia | ||
| 280 | CHC Bezanijska kosa | Belgrade | Serbia | ||
| 281 | KBC Zvezdara | Belgrade | Serbia | ||
| 282 | Clinical Center Kragujevac | Kragujevac | Serbia | ||
| 283 | Institute of cardiovascular diseases Vojvodina | Sremska Kamenica | Serbia | ||
| 284 | Stredodlovensky Ustav Srdcovych A Cievnych Chorob | Banská Bystrica | Slovakia | ||
| 285 | Dr JCW Badenhorst - Netcare Unitas Hospital | Centurion | South Africa | ||
| 286 | Unitas Hospital - Dr. Ebrahim | Centurion | South Africa | ||
| 287 | Unitas Hospital | Centurion | South Africa | ||
| 288 | Milpark Hospital | Johannesburg | South Africa | ||
| 289 | Netcare Union Hospital | Johannesburg | South Africa | ||
| 290 | Ethekwini Hospital & Heart centre | Newlands | South Africa | ||
| 291 | Netcare Greenacres Hospital | Port Elizabeth | South Africa | ||
| 292 | Netcare Unitas Hospital | Pretoria | South Africa | ||
| 293 | Hospital general de Albacete | Albacete | Spain | ||
| 294 | Hospital General de Alicante | Alicante | Spain | ||
| 295 | Hospital Infanta Cristina - Badajoz | Badajoz | Spain | ||
| 296 | Hospital G. Trias i Pujol (Badalona) | Badalona | Spain | ||
| 297 | Hospital de Cruces-Barakaldo | Barakaldo | Spain | ||
| 298 | Bellvitge University Hospital | Barcelona | Spain | ||
| 299 | Hospital del Mar | Barcelona | Spain | ||
| 300 | Hospital Sant Pau (Barcelona) | Barcelona | Spain | ||
| 301 | Hospital V. Hebrón | Barcelona | Spain | ||
| 302 | Hospital Vall d'Hebron | Barcelona | Spain | ||
| 303 | Hospital de Galdakano | Bizkaia | Spain | ||
| 304 | Hospital General Universitario de Burgos | Burgos | Spain | ||
| 305 | Hospital San Pedro de Alcantara-Caceres | Caceres | Spain | ||
| 306 | Hospital Santa Lucia de Cartagena | Cartagena (Murcia) | Spain | ||
| 307 | Hospital Santa Lucia de Cartagena | Cartagena | Spain | ||
| 308 | Universitario Santa Lucia (Hospital Nostra Señora Rossell) (Cartagena) | Cartagena | Spain | ||
| 309 | Hospital General Castellón | Castellón | Spain | ||
| 310 | Hospital General Ciudad Real | Ciudad Real | Spain | ||
| 311 | Hospital de la Cruz Roja de Córdoba | Córdoba | Spain | ||
| 312 | Hospital Reina Sofia de Córdoba | Córdoba | Spain | ||
| 313 | Hospital de Galdakao | Galdakao | Spain | ||
| 314 | Hospital Cabueñes (Gijón) | Gijón | Spain | ||
| 315 | Hospital Universitario de Guadalajara | Guadalajara | Spain | ||
| 316 | Hospital Juan Ramón Jiménez | Huelva | Spain | ||
| 317 | Complexo Hospitalario Universitario A Coruña (CHUAC) | La Coruña | Spain | ||
| 318 | Hospital San Rafael (La Coruña) | La Coruña | Spain | ||
| 319 | Hosp Universitario de Gran Canaria Dr. Negrin | Las Palmas De Gran Canaria | Spain | ||
| 320 | Hospital de León | León | Spain | ||
| 321 | Hospital San Pedro (Logroño - La Rioja) | Logroño | Spain | ||
| 322 | Hospital San Pedro | Logroño | Spain | ||
| 323 | Hospital Universitario Lucus Augusti (HULA) | Lugo | Spain | ||
| 324 | Clinica La Luz | Madrid | Spain | ||
| 325 | Clínica San Fransisco de Asis (Madrid) | Madrid | Spain | ||
| 326 | Hospital 12 Octubre | Madrid | Spain | ||
| 327 | Hospital Fundacion Alcorcon | Madrid | Spain | ||
| 328 | Hospital La Luz | Madrid | Spain | ||
| 329 | Hospital Moncloa (Madrid) | Madrid | Spain | ||
| 330 | Hospital Moncloa | Madrid | Spain | ||
| 331 | Hospital Puerta de Hierro (Madrid) | Majadahonda | Spain | ||
| 332 | Hospital Manises (Valencia) | Manises | Spain | ||
| 333 | Hospital Virgen Arrixaca (Murcia) | Murcia | Spain | ||
| 334 | Hospital de Mérida | Mérida | Spain | ||
| 335 | Universitario central de Asturias (Oviedo) | Oviedo | Spain | ||
| 336 | Universitario central de Asturias | Oviedo | Spain | ||
| 337 | Hospital de Navarra | Pamplona | Spain | ||
| 338 | San Juan de Alicante | San Juan | Spain | ||
| 339 | Hospital de Donostia | San Sebastián | Spain | ||
| 340 | Hospital Universitario Donostia | San Sebastián | Spain | ||
| 341 | Hospital Marqués de Valdecilla, Santander | Santander | Spain | ||
| 342 | Hospital Marqués de Valdecilla | Santander | Spain | ||
| 343 | Hospital Clínico Universitario de Santiago de Compostela | Santiago de Compostela | Spain | ||
| 344 | Hospital Virgen De La Salud (Toledo) | Toledo | Spain | ||
| 345 | Hospital Virgen De La Salud | Toledo | Spain | ||
| 346 | Clínico Universitario Valencia | Valencia | Spain | ||
| 347 | Instituto Cardiologico Hospital Campo Grande (Valladolid) | Valladolid | Spain | ||
| 348 | Instituto Cardiologico Hospital Campo Grande | Valladolid | Spain | ||
| 349 | Hospital Meixoeiro-MEDTEC (Vigo) | Vigo | Spain | ||
| 350 | Hospital Txagorritxu | Vitoria | Spain | ||
| 351 | Hospital Clínico Lozano Blesa de Zaragoza | Zaragoza | Spain | ||
| 352 | Hospital Universitario Miguel Servet | Zaragoza | Spain | ||
| 353 | Gavle Sjukhus | Gavle | Sweden | ||
| 354 | Malarsjukshuet | Malarsjukhuset | Sweden | ||
| 355 | sjukhuset Orebro | Orebro | Sweden | ||
| 356 | Skaraborgs Sjukhus | Skovde | Sweden | ||
| 357 | Skaraborgs sjukhus v Skövde | Skövde | Sweden | ||
| 358 | Sundvalls Sjukhus | Sundvalls | Sweden | ||
| 359 | Vastmanlads Sjukhus | Vasteras | Sweden | ||
| 360 | Västmanlads sjukhus Västerås | Västerås | Sweden | ||
| 361 | Universitets Sjukhuset I Örebro | Örebro | Sweden | ||
| 362 | Spital Thurgau AG | Frauenfeld | Switzerland | ||
| 363 | Hopitaux Universitaires de Genève | Genève | Switzerland | ||
| 364 | Kantonsspital Baselland | Liestal | Switzerland | ||
| 365 | Cardiocenter Lugano, Ticino (TI) | Lugano | Switzerland | ||
| 366 | Cardiocentro Ticino | Lugano | Switzerland | ||
| 367 | Kantonsspital Luzern | Luzern | Switzerland | ||
| 368 | La Tour Hospital | Meyrin Geneva | Switzerland | ||
| 369 | HerzGefässZentrum Zürich | Zürich | Switzerland | ||
| 370 | HerzGefässZentrum | Zürich | Switzerland | ||
| 371 | Paolo Memorial Hospital Phaholyothin | Bangkok | Thailand | ||
| 372 | Police General Hospital | Bangkok | Thailand | ||
| 373 | Ramkhamhaeng Hospital | Bangkok | Thailand | ||
| 374 | HRH Princess Maha Chakri Siridhorn Medical Center | Nakhon Navok | Thailand | ||
| 375 | HRH Princess Maha Chakri Sirindhorn Medical Center (Nakornayok) | Nakhon Navok | Thailand | ||
| 376 | Central Chest Institute of Thailand | Nonthaburi | Thailand | ||
| 377 | Phatara Thonburi Hospital | Pathum Thani | Thailand | ||
| 378 | Udonthani HP. | Udon Thani | Thailand | ||
| 379 | Udonthani Hospital | Udonthani | Thailand | ||
| 380 | Clinique Hannibal Lac 2_Dr. Mohamed Drissa | El Mourouj | Tunisia | ||
| 381 | Clinique Générale et Cardiovasculaire de Tunis_Dr. Sami Bouziri | La Marsa | Tunisia | ||
| 382 | Bassatine Clinic_Dr. Elyes Kharrat | Sfax | Tunisia | ||
| 383 | Polyclinique Bassatine Cite gardin Sfax_Dr. Zeineb Grati Guermazi | Sfax | Tunisia | ||
| 384 | Polyclinique El Bassatine SFAX_Dr. Sami Fourati | Sfax | Tunisia | ||
| 385 | Polyclinique El bassatine_Dr. Mohamed Najeh Abid | Sfax | Tunisia | ||
| 386 | Polyclinique El Bassatine_Dr. Ridha Ennouri | Sfax | Tunisia | ||
| 387 | Centre Urbain Nord_Dr. Salem Abdessalem | Tunis | Tunisia | ||
| 388 | Clinique Cartagène_Dr. Dhaker Lahidheb | Tunis | Tunisia | ||
| 389 | Clinique Général et Cardiovasculaire de Tunis_Dr. Saloua Trabelsi | Tunis | Tunisia | ||
| 390 | Clinique Générale et Cardiovasculaire de Tunis_Dr. Saloua TRABELSI | Tunis | Tunisia | ||
| 391 | Clinique Hannibal Lac 2_Gharbi Mostari | Tunis | Tunisia | ||
| 392 | Clinique Montplaisir_Dr. Badi Darghouth | Tunis | Tunisia | ||
| 393 | HU Mohamed Taher El Maâmouri | Tunis | Tunisia | ||
| 394 | Policlinique Taoufik_Jamel Langar | Tunis | Tunisia | ||
| 395 | Soukra Medical_Dr. Ben Chedli Tarek | Tunis | Tunisia | ||
| 396 | Heart Institute | Kiev | Ukraine | ||
| 397 | Institute of Heart (Ministry of Health) | Kiev | Ukraine | ||
| 398 | NAMS Amosov | Emergency Endovascular Surgery department | Kiev | Ukraine | ||
| 399 | NAMS Amosov | X-Ray diagnostics and invasive cardiology department | Kiev | Ukraine | ||
| 400 | National Institute of Cardiovascular Surgery NAMS | Kiev | Ukraine | ||
| 401 | National Institute of Surgery and Transplantology NAMS | Kiev | Ukraine | ||
| 402 | S.P.M.C. of Pediatric Cardiology and Cardiac Surgery | Kiev | Ukraine | ||
| 403 | Strazhesko Institute of Cardiology (National Scientific Centre) | Kiev | Ukraine | ||
| 404 | Government institution Regional centre of cardiac and vessel disease | Zaporizhzhya | Ukraine | ||
| 405 | Al Noor Hospital-Airport Rd. | Abu Dhabi | United Arab Emirates | ||
| 406 | LifeCare Hospital | Abu Dhabi | United Arab Emirates | ||
| 407 | Al Zahra Private hospital, Dubai | Dubai | United Arab Emirates | ||
| 408 | Belhoul Speciality Hospital | Dubai | United Arab Emirates | ||
| 409 | Dr. Sulaiman Al Habib Hospital | Dubai | United Arab Emirates | ||
| 410 | Dubai Hospital | Dubai | United Arab Emirates | ||
| 411 | Iranian hospital | Dubai | United Arab Emirates | ||
| 412 | Prime Hospital | Dubai | United Arab Emirates | ||
| 413 | Rashid Hospital | Dubai | United Arab Emirates | ||
| 414 | Al Qassimi Hopsital | Sharja | United Arab Emirates | ||
| 415 | Royal Brompton and Harefield | Chelsea | London | United Kingdom | SW3 5UE |
| 416 | Essex Cardiothoracic centre | Basildon | United Kingdom | ||
| 417 | Royal United Hospital, Bath | Bath | United Kingdom | ||
| 418 | Bedford Hospital | Bedford | United Kingdom | ||
| 419 | Queen Elizabeth Hospital | Birmingham | United Kingdom | ||
| 420 | Sandwell and West Birmingham Hospitals | Birmingham | United Kingdom | ||
| 421 | Royal Blackburn Hospital | Blackburn | United Kingdom | ||
| 422 | Blackpool Victoria Hospital | Blackpool | United Kingdom | ||
| 423 | Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust | Bournemouth | United Kingdom | ||
| 424 | Bradford teaching hospitals | Bradford | United Kingdom | ||
| 425 | Royal Sussex Hospital, Brighton | Brighton | United Kingdom | ||
| 426 | University Hospital Wales | Cardiff | United Kingdom | ||
| 427 | Croydon University Hospital | Croydon | United Kingdom | ||
| 428 | Royal Derby Hospital | Derby | United Kingdom | ||
| 429 | Dorset County Hospital | Dorchester | United Kingdom | ||
| 430 | Eastbourne and Conquest Hospitals | Eastbourne | United Kingdom | ||
| 431 | Freeman Hospital | Freeman | United Kingdom | ||
| 432 | West Middlesex Hospital | Isleworth | United Kingdom | ||
| 433 | Kettering General Hospital | Kettering | United Kingdom | ||
| 434 | University Hospitals of Leicester | Leicester | United Kingdom | ||
| 435 | Lincoln County Hospital | Lincoln | United Kingdom | ||
| 436 | Royal Free Hospital | London | United Kingdom | ||
| 437 | The Royal Free Hospital | London | United Kingdom | ||
| 438 | University Hospital of South Manchester | Manchester | United Kingdom | ||
| 439 | James Cook University Hospital | Middlesbrough | United Kingdom | ||
| 440 | Wolverhampton | New Cross | United Kingdom | ||
| 441 | Royal Gwent Hospital, Newport | Newport | United Kingdom | ||
| 442 | Northwick Park Hospital | Northwick Park | United Kingdom | ||
| 443 | Norfolk and Norwich University Hospital | Norwich | United Kingdom | ||
| 444 | Nottingham University Hospitals - Queen's Medical Centre | Nottingham | United Kingdom | ||
| 445 | Queens medical center Nottingham | Nottingham | United Kingdom | ||
| 446 | Bircham Park Offices Plymouth | Plymouth | United Kingdom | ||
| 447 | Plymouth Hospital | Plymouth | United Kingdom | ||
| 448 | Royal Berkshire | Reading | United Kingdom | ||
| 449 | Salisbury District Hospital | Salisbury | United Kingdom | ||
| 450 | Sheffield teaching hospital | Sheffield | United Kingdom | ||
| 451 | Lister Hospital, Stevenage | Stevenage | United Kingdom | ||
| 452 | Royal Stoke University Hospital | Stoke-on-Trent | United Kingdom | ||
| 453 | King's Mill Hospital | Sutton in Ashfield | United Kingdom | ||
| 454 | Royal Cornwall Hospitals | Truro | United Kingdom | ||
| 455 | Tunbridge Wells Hospital | Tunbridge Wells | United Kingdom | ||
| 456 | Coventry and Warwickshire | Walsgrave | United Kingdom | ||
| 457 | Wrightington Hospital | Wigan | United Kingdom | WN6 9EP | |
| 458 | Worcestershire Acute Hospitals | Worcestershire | United Kingdom | ||
| 459 | Worthing Hospital, West Sussex | Worthing | United Kingdom | ||
| 460 | Buckinghamshire, Wycombe | Wycombe | United Kingdom | ||
| 461 | Republic Specialized Center of Surgery | Tashkent | Uzbekistan | ||
| 462 | Thong Nhat Hospital | Hò Chi Minh City | Vietnam |
Sponsors and Collaborators
- Terumo Europe N.V.
Investigators
- Study Director: Vladimir Borovicanin, MD, Terumo Europe
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Terumo Europe N.V.
ClinicalTrials.gov Identifier:
NCT02188355
Other Study ID Numbers:
- T123E2
First Posted:
Jul 11, 2014
Last Update Posted:
Oct 8, 2019
Last Verified:
Oct 1, 2019
Keywords provided by Terumo Europe N.V.
Additional relevant MeSH terms: