Clinical trial NCT01261273: e-NOBORI Observational Registry of Nobori DES
Official title: Prospective, Single-Arm, Multi-Centre, Observational Registry to Further Validate Safety and Efficacy of the Nobori DES in Real-World Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: PCI
observational registry
Lead sponsor: Terumo Europe N.V.
Sponsor class: INDUSTRY
First posted: 2010-12-16
Enrollment: 18000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suitable for PCI intervention

Brief summary: Title Prospective, single-arm, multi-centre, observational registry to further validate safety and efficacy of the Nobori® DES in real-world patients.

Objective Primary objective The primary objective of e-NOBORI registry is to further validate the safety and efficacy of Nobori® DES system in unselected patients representing everyday clinical practice.

Primary Endpoint: Freedom from Target Lesion Failure (TLF) defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 1 year

Detailed description: * Title Prospective, single-arm, multi-centre, observational registry to further validate safety and efficacy of the Nobori® DES in real-world patients.
* Primary objective The primary objective of e-NOBORI registry is to further validate the safety and efficacy of Nobori® DES system in unselected patients representing everyday clinical practice.
* Primary Endpoint: Freedom from Target Lesion Failure (TLF) defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 1 year
* Clinical Site Locations:

Up to 200 centres across Europe, Asia and Central and South America

-Patient Population : \~18000 eligible patients suitable for treatment with the Nobori® DES will be entered in the e-NOBORI registry

Eligibility Criteria

* Patient is more or equal 18 years old;
* Patient is, according to hospital routine practice, eligible for percutaneous coronary intervention using DES (and RVD matches available Nobori® DES sizes);
* Patient has been informed of the nature of the study and agrees to its provisions, has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site, wherever such requirement exists.

NOTE: In order to avoid bias it is recommended that all investigators aim to enrol all consecutive patients complying with study eligibility criteria. It is also desirable to have at least two cardiologists as investigators in each centre.

According to pre-specified criteria, patients will be automatically allocated to one or more sub-studies as following:

* NOBORI Acute Coronary Syndrome
* NOBORI Stable angina
* NOBORI Female
* NOBORI Bifurcation
* NOBORI Diabetes

  * Insulin Dependent Diabetes Mellitus (IDDM)
  * Non-Insulin Dependent Diabetes Mellitus (NIDDM)
* NOBORI Small Vessels (less or equal 2.75mm)
* NOBORI Long Lesions (more or equal 20mm)
* NOBORI Renal Insufficiency (\> 2.0 mg/dL - 176 µmol/mL)
* NOBORI Elderly (more or equal 80 years of age)
* NOBORI Restenosis
* NOBORI Multivessel Treatment
* NOBORI Complex Lesions

In addition to above mentioned sub-studies there will be geographic sub-studies for the main areas.

Medication Pre-Procedure: According to hospital routine practice Post-Procedure: Mandatory antiplatelet treatment, according to hospital routine practice (minimum 6 months DAT)

Eligibility criteria: Inclusion Criteria:

* Patient is more or equal 18 years old;
* Patient is, according to hospital routine practice, eligible for percutaneous coronary intervention using DES (and RVD matches available Nobori® DES sizes);
* Patient has been informed of the nature of the study and agrees to its provisions, 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:

* None

Primary outcomes:
measure: FREEDOM OF TARGET LESION FAILURE
timeFrame: 1 YEAR
Secondary outcomes:
measure: Procedural success
timeFrame: 1 MONTH
measure: Device success
timeFrame: 1 MONTH
measure: Acute/subacute stent thrombosis
timeFrame: 1 MONTH
measure: Peri-procedural myocardial infarction
timeFrame: 1 MONTH
measure: Rate of Major Adverse Cardiac Events (MACE)
timeFrame: 1 MONTH
measure: Major vascular and bleeding complications
timeFrame: 1 MONTH
measure: Cardiac death/ Myocardial Infarction
timeFrame: 1 AND 2 YEARS
measure: Clinically driven target lesion revascularization (TLR)
timeFrame: 1 & 2 YEARS
measure: Stent thrombosis
timeFrame: 1 AND 2 YEARS
measure: Clinically driven target vessel revascularization (TVR)
timeFrame: 1 AND 2 YEARS
measure: Target Lesion Failure (TLF)
timeFrame: 1 MONTH AND 2 YEARS
measure: Patient Oriented Composite Endpoint defined as any cause of mortality, MI (Q-wave and non Q-wave), or any TVR
timeFrame: 1 MONTH, 1 AND 2 YEARS
measure: Composite Endpoint of Cardiac death and MI
timeFrame: 1 MONTH, 1 AND 2 YEARS
measure: Composite Endpoint of Cardiac death and post-procedural MI
timeFrame: 1 month, 1 and 2 years post-procedure
measure: Stent thrombosis
timeFrame: 1 month, 1 and 2 years post-procedure
measure: Primary Stent thrombosis
timeFrame: 1 month, 1 and 2 years post-procedure
measure: Secondary Stent thrombosis
timeFrame: 1 month, 1 and 2 years post-procedure
measure: Duration of dual antiplatelet therapy
timeFrame: UP TO 2 YEARS
measure: Composite Endpoint of Cardiac death, post-procedural MI and stent thrombosis rate during the course of DAT versus the same events after cessation of DAT
timeFrame: UP TO 2 YEARS
measure: Clinically driven Target Lesion Revascularization
timeFrame: 1 MONTH
measure: Clinically driven Target Vessel Revascularization
timeFrame: 1 MONTH
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: SMZ-Donauspital Vienna
city: Dhaka
country: Bangladesh
facility: National Heart Foundation Hospital & Research Institute
city: Minsk
country: Belarus
facility: Republican Clinical Medical Center (Presidential Hospital)
city: Minsk
country: Belarus
facility: Republican Scientific and Practical Center of Cardiology
city: Mogilev
country: Belarus
facility: Mogilev Regional Clinical Hospital
city: Belo Horizonte
country: Brazil
facility: Hospital Madre Teresa
city: Blumenau
country: Brazil
facility: Hospital Santa Isabel-Sociedade Divina Providência
city: Campinas
country: Brazil
facility: HMCP PUC-Campinas
city: Campinas
country: Brazil
facility: Hospital E Maternidade Madre Teodora
city: Campinas
country: Brazil
facility: Hospital Vera Cruz Campinas
city: Cuiaba
country: Brazil
facility: Hospital Geral Universitário
city: Curitiba
country: Brazil
facility: Hospital Cruz Vermelha Brasileira Filial do Paraná
city: Curitiba
country: Brazil
facility: Hospital Nossa Senhora das Graças
city: Curitiba
country: Brazil
facility: Hospital Santa Cruz
city: Juiz de Fora
country: Brazil
facility: Hospital Monte Sinai (Juiz de Fora)
city: Linhares
country: Brazil
facility: Instituto Cardiovascular de Linhares (Unicor)
city: Londrina
country: Brazil
facility: Hospital do Coração de Londrina
city: Marilia
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Marília
city: Maringá
country: Brazil
facility: Hospital Paraná
city: Niterói
country: Brazil
facility: Hospital Procordis
city: Patos de Minas
country: Brazil
facility: Hospital Vera Cruz Patos de Minas
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
city: Porto Alegre
country: Brazil
facility: Hospital Mãe De Deus
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas - PUCRS
city: Rio de Janeiro
country: Brazil
facility: Clinica Status Cor
city: rio de Janeiro
country: Brazil
facility: Hospital Naval Marcíllo Dias
city: Salvador
country: Brazil
facility: Fundação Bahiana de Cardiologia (MC Oliveira Prest
city: Sao Joao do Paraiso
country: Brazil
facility: Hospital Beneficencia Portuguesa de Sao Paulo
city: Sao Paulo
country: Brazil
facility: Casa de Saude Santa Marcelina
city: Sao Paulo
country: Brazil
facility: Hospital Albert Einstein
city: Sao Paulo
country: Brazil
facility: Hospital Bandeirantes
city: Sao Vicente
country: Brazil
facility: Hospital Ana Costa (ENDOCOR Serviços Médicos Ltda)
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese
city: São Paulo
country: Brazil
facility: Real e Benemérita Assoção Portuguesa de Beneficênc
city: Taguatinga
country: Brazil
facility: Hospital Anchieta Ltda.
city: Uberlândia
country: Brazil
facility: Instituto do Coração do Triângulo Mineiro
city: Vitória
country: Brazil
facility: Insituto de Cardiologia Espirito Santo
city: Sofia
country: Bulgaria
facility: Tokuda Hospital Sofia
city: La Reina
country: Chile
facility: Hospital Militar de Santiago
city: Santiago de Chile
country: Chile
facility: clinica Santa Maria
city: Santiago
country: Chile
facility: Instituto Nacional del Torax
city: Santiago
country: Chile
facility: San Juan de Dios
city: Talcahuano
country: Chile
facility: Las Higueras De Talcahuano
city: Valparaíso
country: Chile
facility: V Region (Hospital Gustavo Fricke, Hospital Van Buren, Clinica Reñaca)
city: Vitacura
country: Chile
facility: Clinica alemana de Santiago
city: Brno
country: Czechia
facility: St. Anne University Hospital
city: Praha
country: Czechia
facility: Nemocnice Na Homolce
city: Hellerup
country: Denmark
facility: Gentofte Hospital (M12FU)
city: Alexandria
country: Egypt
facility: ALHYATT Cardiovascular Center
city: Alexandria
country: Egypt
facility: International Cardiac Center
city: Cairo
country: Egypt
facility: AL Amal
city: Cairo
country: Egypt
facility: Al Nakhil hospital
city: Cairo
country: Egypt
facility: AS-Salam Mohndseen
city: Cairo
country: Egypt
facility: Cleopatra
city: Cairo
country: Egypt
facility: Egyheart - cath lab
city: Cairo
country: Egypt
facility: El Dorah Heart Care Center
city: Cairo
country: Egypt
facility: Hayat Hospital
city: Giza
country: Egypt
facility: (DAFH) Dar Al Fouad Hospital
city: Giza
country: Egypt
facility: Alfa
city: Giza
country: Egypt
facility: ICS center
city: Giza
country: Egypt
facility: RCC Cardiac center
city: Mansourah
country: Egypt
facility: Glory cardiac center - Cath group
city: Sohag
country: Egypt
facility: Al Noor Cath Lab
city: Tanta
country: Egypt
facility: Om El kora cardiac center
city: Tallin
country: Estonia
facility: East Tallinn Central Hospital
city: Tallin
country: Estonia
facility: North-Estonia Regional Hospital
city: Amiens
country: France
facility: Clinique de l'Europe à Amiens (SAS Cardio Amiens)
city: Angers
country: France
facility: CHU Angers
city: Antony
country: France
facility: Hôpital Privé d'Antony
city: Aubervilliers
country: France
facility: Hopital La Roseraie
city: Avignon
country: France
facility: CH Avignon
city: Avignon
country: France
facility: Clinique Rhone Durance
city: Bastia Cedex
country: France
facility: CH Bastia
city: Bayonne
country: France
facility: Clinique La Fourcade
city: Bois-Bernard
country: France
facility: Clinique Bois Bernard à Bois Bernard
city: Bordeaux
country: France
facility: Clinique Saint Augustin
city: Brest
country: France
facility: CHU de la Cavale Blanche
city: Caen
country: France
facility: CH Privé Saint - Martin Caen
city: Caen
country: France
facility: CHU de la Cote de Nacre (CHU Caen)
city: Colmar
country: France
facility: Hopital Albert Schweitzer-Colmar
city: Corbeil Essonnes
country: France
facility: CH Sud Francilien
city: Cornebarrieu
country: France
facility: Clinique des Cèdres-Dr Brunelle
city: Cornebarrieu
country: France
facility: Clinique des Cèdres-Dr.Tauzin
city: Evecquemont
country: France
facility: Centre Cardiologique d'Evecquemont
city: Haguenau
country: France
facility: CH Haguenau
city: Jossigny
country: France
facility: CH de Lagny-Marne La Vallée
city: La Cornuaille
country: France
facility: CH de Cornouaille
city: La Roche sur Yon
country: France
facility: CH La Roche sur Yon
city: Le Coudray
country: France
facility: CH de Chartres
city: Le Plessis Robinson
country: France
facility: CC Marie Lannelongue
city: Lille
country: France
facility: Clinique La Louviere
city: Limoges Cedex
country: France
facility: CH Dupuytren Limoges
city: Lorient
country: France
facility: CH Lorient
city: Massy
country: France
facility: Institut Hospitalier Jacques Cartier (ICPS Massy)
city: Melun
country: France
facility: Clinique les Fontaines
city: Montpellier
country: France
facility: Clinique du Millenaire
city: Paris
country: France
facility: Association Clinique Bizet
city: Paris
country: France
facility: Clinique Turin - Paris
city: Paris
country: France
facility: Hopital Lariboisière
city: Paris
country: France
facility: Hopital Pitié Salpétrière
city: Paris
country: France
facility: Hôpital du Val de Grâce
city: Paris
country: France
facility: Hôpital Europeen Georges Pompidou (HEGP)
city: Pau
country: France
facility: CH Pau
city: Perigueux
country: France
facility: CH Périgueux
city: Perpignan
country: France
facility: CH Général Maréchal Joffre Perpignan
city: Pessac
country: France
facility: Clinique Saint-Martin Pessac
city: Poitiers
country: France
facility: CHU La Miletrie Poitiers
city: Pontoise
country: France
facility: CH René Dubos
city: Quincy
country: France
facility: Hopital Claude Galien
city: Rennes
country: France
facility: Clinique Saint Laurent
city: Rodez
country: France
facility: Hôpital Jacques Puel (CH de Rodez)
city: Rouen
country: France
facility: Clinique Saint Hilaire
city: Saint Denis
country: France
facility: Centre Cardiologique du Nord
city: Strasbourg
country: France
facility: NHC Strasbourg
city: Tarbes
country: France
facility: Clinique de l'Ormeau - CCV des Pyrenées
city: Toulouse
country: France
facility: Polyclinique du Parc Toulouse
city: Valence
country: France
facility: CH Valence
city: Valenciennes
country: France
facility: Clinique Vauban
city: Vannes
country: France
facility: CH Bretagne Atlantique
city: Tbilisi
country: Georgia
facility: JoAnn Medical Center
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Bad Oeynhausen
country: Germany
facility: Herz-und Diabeteszentrum Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Evangelisch Freikirchliches Krankenhaus und Herzze
city: Berlin
country: Germany
facility: Gemeinschaftskrankenhaus Havelhöhe
city: Berlin
country: Germany
facility: Jüdisches Krankenhaus
city: Berlin
country: Germany
facility: Klinikum Neukölln
city: Berlin
country: Germany
facility: Vivantes Klinkum Spandau
city: Berlin
country: Germany
facility: Vivantes Netzwerk für Gesundheit gmbH - Am Urban
city: Berlin
country: Germany
facility: Vivantes Netzwerk für Gesundheit gmbH - Friedrichs
city: Berlin
country: Germany
facility: Vivantes Netzwerk für Gesundheit gmbH - Humboldt
city: Duisburg
country: Germany
facility: Ev.Bethesda-Johanniter Klinikum Duisburg GmbH
city: Fulda
country: Germany
facility: Klinikum Fulda
city: Kiel
country: Germany
facility: Uniklinik Schleswig-Holstein, Campus Kiel
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig-Rhöne Klinikum
city: Lünen
country: Germany
facility: St. Marienhospital Lünen
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
city: Rostock
country: Germany
facility: Universitätsklinik Rostock
city: Speyer
country: Germany
facility: Evang.Diakonieanstalt Speyer
city: Budapest
country: Hungary
facility: Gottsegen National Cardiology Institute (GOKI)
city: Budapest
country: Hungary
facility: Semmelweis University Cardiology Centre
city: Székesfehérvár
country: Hungary
facility: Fejér Megyei Szent György Kórház
city: Jakarta
country: Indonesia
facility: Medistra Hospital
city: Jakarta
country: Indonesia
facility: National Cardiovascular Center Harapan Kita
city: Surabaya
country: Indonesia
facility: Dr. Soetomo General Hospital, Surabaya
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Galway
country: Ireland
facility: University Hospital Galway
city: Haifa
country: Israel
facility: Rambam Medical centre
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Kfar-Saba
country: Israel
facility: Meir Medical Center, Kfar-Saba
city: Netanya
country: Israel
facility: Laniado Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Rehovot
country: Israel
facility: Kaplan Hospital
city: Riga
country: Latvia
facility: Invasive Cardiology Laboratory of Clinics "Gailezers" of Riga's Eastern Clinical University Hospital
city: Riga
country: Latvia
facility: Invasive Cardiology Laboratory of P. Stradins Clinical University Hospital
city: Kaunas
country: Lithuania
facility: Hospital of Lithuania University of Health Science
city: Msida
country: Malta
facility: Mater Dei
city: Ciudad de Mexico
country: Mexico
facility: 1e de Octubre ISSSTE
city: Culiacán
country: Mexico
facility: Hospital Angeles Culiacan
city: León, Guanajuato
country: Mexico
facility: Hospital Angeles Leon
city: Merida, Yucatan
country: Mexico
facility: Hospital Star Medica Mérida Yucatán
city: Mexico City
country: Mexico
facility: Hospital Central Militar
city: Mexico DF
country: Mexico
facility: Hospital Angeles Mocel
city: Mexico DF
country: Mexico
facility: Hospital de Cardiologia C.M.N.
city: Mexico DF
country: Mexico
facility: Instituto Nacional De Cardiologia "Ignacio Chávez"
city: Mexico, D.F.
country: Mexico
facility: Centro Médico Nacional 20 de Noviembre
city: Monterrey, Nuevo León
country: Mexico
facility: Hospital Universitario Dr. José Eleuterio Gonzalez
city: México, DF
country: Mexico
facility: Dalinde Medical Center
city: San Luis Potosi SLP
country: Mexico
facility: Hospital Lomas de San Luis Internacional
city: Breda
country: Netherlands
facility: Amphia Hospital
city: Den Haag
country: Netherlands
facility: Medisch Centrum Haaglanden
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Hospital
city: s'Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Gdansk
country: Poland
facility: St Adalbert Speciality Hospital
city: Poznan
country: Poland
facility: Szpital Klinicznk Przemienienia (University Hospital)
city: Poznan
country: Poland
facility: Szpital Wojewodzski Poznaniu
city: Timisoara
country: Romania
facility: Cardiolife Hospital Timisoara
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Hospital
city: Krasnogorsk
country: Russian Federation
facility: Military Hospital N3 named by Vishnevsky
city: Krasnoyarsk
country: Russian Federation
facility: State cardiovascular center based on regional clin
city: Kursk
country: Russian Federation
facility: Regional Clinical Hospital
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital N°2 Russia Railways
city: Novosibirsk
country: Russian Federation
facility: Academian E.N Meshalkin State Research Institute of circulation Pathology
city: Penza
country: Russian Federation
facility: Federal cardiosurgerical center, Penza
city: Saint-Petersburg
country: Russian Federation
facility: Federal center of heart,blood and endocrinology diseases named by Almazov
city: Saratov
country: Russian Federation
facility: Saratov Research Institute of science for cardiology
city: St-Petersburg
country: Russian Federation
facility: Kirochnaya str.41
city: Ufa
country: Russian Federation
facility: Regional Vessel Center
city: Ufa
country: Russian Federation
facility: Ufa city Emergency Hospital
city: Dedinje
country: Serbia
facility: Institute for Cardiovascular Disease Dedinje
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Niš
country: Serbia
facility: Clinical Center of Niš
city: Celje
country: Slovenia
facility: CH Celje
city: Albacete
country: Spain
facility: Hospital general de Albacete
city: Alicante
country: Spain
facility: Hospital San Juan
city: Almeria
country: Spain
facility: Hospital Torrecárdenas
city: Badalona
country: Spain
facility: Hospital G. Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Bellvitge
city: Barcelona
country: Spain
facility: Hospital Sant Pau
city: Bilbao- Vizcaya
country: Spain
facility: Hospital de Cruces-Barakaldo
city: Bizkaia
country: Spain
facility: Hospital de Galdakao
city: Caceres
country: Spain
facility: Hospital San Pedro de Alcantara-Caceres
city: Cartagena
country: Spain
facility: Hospital Nostra Señora Rossell
city: Castellón
country: Spain
facility: Hospital General de Castellón
city: Ciudad Real
country: Spain
facility: Hospital Nostra Señora Alarcos
city: Gijón
country: Spain
facility: Hospital Cabueñes
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara
city: La Coruña
country: Spain
facility: Hospital Juan Canalejo
city: La Coruña
country: Spain
facility: Hospital San Rafael
city: Las Palmas
country: Spain
facility: Clinica San Roque
city: León
country: Spain
facility: Hospital de León
city: Madrid
country: Spain
facility: Clínica Moncloa
city: Madrid
country: Spain
facility: Hospital Fundacion Alcorcon
city: Majadahonda-Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Murcia
country: Spain
facility: Hospital Virgen Arrixaca
city: Oviedo
country: Spain
facility: Universitario central de Asturias
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
city: Tenerife
country: Spain
facility: Hospital Candelaria
city: Toledo
country: Spain
facility: Hospital Virgen Salud
city: Valencia
country: Spain
facility: Clínico Universitario Valencia
city: Valencia
country: Spain
facility: Hospital Manises
city: Vigo
country: Spain
facility: Hospital Meixoeiro-MEDTEC
city: Vitoria
country: Spain
facility: Hospital Txagorritxu
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
city: Falun
country: Sweden
facility: Falun Lasarett
city: Linköping
country: Sweden
facility: University Hospital Linköping
city: Uppsala
country: Sweden
facility: Uppsala Akademiska Sjukhus, Kardiologkliniken
city: Västerås
country: Sweden
facility: Central Lasarettet i Västerås, Angio/PCI lab. Medi
city: Kaohsiung
country: Taiwan
facility: E-da Hospital/Kaohsiung
city: Taichung R.O.C.
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center/Tainan
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Cheng Hsin General Hospital / Taipei
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital, VACRS
city: Kharkov
country: Ukraine
facility: Kharkov Regional Hospital
city: Kiev
country: Ukraine
facility: Feofaniya
city: Kiev
country: Ukraine
facility: Ukrainian Institute of Cardiology
city: Kyiv
country: Ukraine
facility: National Institute of Cardiovascular Surgery AMS
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Birmingham
city: Blackpool
country: United Kingdom
facility: Royal Blackpool hospital (Lancashire Heart Centre)
city: Cornwell
country: United Kingdom
facility: Royal Cornwall hospital
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
city: Craigavon
country: United Kingdom
facility: Southern Health and Social Care Trust Craigavon Ar
city: District Of North East Lincolnshire
country: United Kingdom
facility: Scunthorpe general hospital
city: Dorset
country: United Kingdom
facility: Dorset county Hospital
city: Eastbourne
country: United Kingdom
facility: Eastbourne General
city: Glenfield
country: United Kingdom
facility: Glenfield general hospital
city: Hastings
country: United Kingdom
facility: Conquest Hospital Hastings
city: Kettering
country: United Kingdom
facility: Kettering General Hospital
city: London
country: United Kingdom
facility: Northwick Park
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Newport
country: United Kingdom
facility: Royal Gwent Hospital
city: North Manchester
country: United Kingdom
facility: Fairfield General Hospital
city: Surrey
country: United Kingdom
facility: Frimley Park Hospital NHS Foundation Trust
city: Wakefield
country: United Kingdom
facility: Pinderfield General Hospital
city: Wednesfield
country: United Kingdom
facility: New Cross Wolverhampton
Study officials:
affiliation: Terumo Europe
name: Dragica Paunovic, Dr.
role: STUDY_CHAIR
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