e-NOBORI Observational Registry of Nobori DES

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Terumo Europe N.V.
ClinicalTrials.gov Identifier:
NCT01261273
First received: December 14, 2010
Last updated: May 11, 2015
Last verified: May 2015
  Purpose

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


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective, Single-Arm, Multi-Centre, Observational Registry to Further Validate Safety and Efficacy of the Nobori DES in Real-World Patients

Further study details as provided by Terumo Europe N.V.:

Primary Outcome Measures:
  • FREEDOM OF TARGET LESION FAILURE [ Time Frame: 1 YEAR ] [ Designated as safety issue: Yes ]
    TLF: COMPOSITE OF CARDIAC DEATH, MYOCARDIAL INFARCTION AND TARGET LESION REVASCULARIZATION


Secondary Outcome Measures:
  • Procedural success [ Time Frame: 1 MONTH ] [ Designated as safety issue: No ]
  • Device success [ Time Frame: 1 MONTH ] [ Designated as safety issue: No ]
  • Acute/subacute stent thrombosis [ Time Frame: 1 MONTH ] [ Designated as safety issue: Yes ]
    (definite/probable according to ARC definitions)

  • Peri-procedural myocardial infarction [ Time Frame: 1 MONTH ] [ Designated as safety issue: Yes ]
  • Rate of Major Adverse Cardiac Events (MACE) [ Time Frame: 1 MONTH ] [ Designated as safety issue: Yes ]
    Major Adverse Cardiac Events (MACE) defined as a composite of cardiac death, MI or clinically driven target vessel revascularization (TVR)

  • Major vascular and bleeding complications [ Time Frame: 1 MONTH ] [ Designated as safety issue: No ]
    NOT CABG RELATED

  • Cardiac death/ Myocardial Infarction [ Time Frame: 1 AND 2 YEARS ] [ Designated as safety issue: Yes ]
  • Clinically driven target lesion revascularization (TLR) [ Time Frame: 1 & 2 YEARS ] [ Designated as safety issue: Yes ]
    re-PCI or CABG involving target lesion

  • Stent thrombosis [ Time Frame: 1 AND 2 YEARS ] [ Designated as safety issue: Yes ]
    (definite/probable; ARC definition)

  • Clinically driven target vessel revascularization (TVR) [ Time Frame: 1 AND 2 YEARS ] [ Designated as safety issue: Yes ]
    PCI AND CABG

  • Target Lesion Failure (TLF) [ Time Frame: 1 MONTH AND 2 YEARS ] [ Designated as safety issue: Yes ]
    Defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization

  • Patient Oriented Composite Endpoint defined as any cause of mortality, MI (Q-wave and non Q-wave), or any TVR [ Time Frame: 1 MONTH, 1 AND 2 YEARS ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Cardiac death and MI [ Time Frame: 1 MONTH, 1 AND 2 YEARS ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Cardiac death and post-procedural MI [ Time Frame: 1 month, 1 and 2 years post-procedure ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 1 month, 1 and 2 years post-procedure ] [ Designated as safety issue: Yes ]
    definite and probable according to ARC definitions

  • Primary Stent thrombosis [ Time Frame: 1 month, 1 and 2 years post-procedure ] [ Designated as safety issue: Yes ]
    definite and probable according to ARC definitions

  • Secondary Stent thrombosis [ Time Frame: 1 month, 1 and 2 years post-procedure ] [ Designated as safety issue: Yes ]
    definite and probable according to ARC definitions

  • Duration of dual antiplatelet therapy [ Time Frame: UP TO 2 YEARS ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: UP TO 2 YEARS ] [ Designated as safety issue: Yes ]
  • Clinically driven Target Lesion Revascularization [ Time Frame: 1 MONTH ] [ Designated as safety issue: Yes ]
  • Clinically driven Target Vessel Revascularization [ Time Frame: 1 MONTH ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18000
Study Start Date: August 2010
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stable angina
Patient admitted with stable angina
Acute Coronary Syndrome
Patients admitted with Acute Coronary Syndrome
Female
Participant female patients
Bifurcation
One or more lesions treated during the baseline in bifurcation
Insulin Dependent Diabetes Mellitus
Patients that were insulin-dependent diabetes mellitus at admission
Non-Insulin Dependent Diabetes Mellitus
Patients that were non-insulin-dependent diabetes mellitus at admission
Small Vessels
vessels smaller or equal to 2.75mm
NOBORI Long Lesions
Lesions longer or equal to 20mm
Renal Insufficiency
Patients that at admission had renal insufficiency (> 2.0 mg/dL - 176 µmol/mL) at admission
Elderly
Patients more or equal 80 years old
Restenosis
One or more lesions treated during the baseline in were restenotic lesions
Multivessel Treatment
Patients who underwent the treatment of more than 1 vessel during the index procedure
Complex Lesions
Patients who underwent a PCI on the Left Main Trunk, on a Chronic Total Occluded lesion or located on a Saphenous Vein Graft
Overall
Total Population

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients suitable for PCI intervention

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261273

  Hide Study Locations
Locations
Austria
SMZ-Donauspital Vienna
Vienna, Austria
Bangladesh
National Heart Foundation Hospital & Research Institute
Dhaka, Bangladesh
Belarus
Republican Clinical Medical Center (Presidential Hospital)
Minsk, Belarus
Republican Scientific and Practical Center of Cardiology
Minsk, Belarus
Mogilev Regional Clinical Hospital
Mogilev, Belarus
Brazil
Hospital Madre Teresa
Belo Horizonte-Minas Gerais, Brazil
Hospital Santa Isabel-Sociedade Divina Providência
Blumenau, Brazil
Hospital Vera Cruz Campinas
Campinas, Brazil
Hospital E Maternidade Madre Teodora
Campinas - SP, Brazil
HMCP PUC-Campinas
Campinas - SP, Brazil
Hospital Geral Universitário
Cuiaba, Brazil
Hospital Santa Cruz
Curitiba, Brazil
Hospital Nossa Senhora das Graças
Curitiba, Brazil
Hospital Cruz Vermelha Brasileira Filial do Paraná
Curitiba, Brazil
Hospital Monte Sinai (Juiz de Fora)
Juiz de Fora, Brazil
Instituto Cardiovascular de Linhares (Unicor)
Linhares, Brazil
Hospital do Coração de Londrina
Londrina, Brazil
Irmandade da Santa Casa de Misericórdia de Marília
Marilia, Brazil
Hospital Paraná
Maringá, Brazil
Hospital Procordis
Niterói, Brazil
Hospital Vera Cruz Patos de Minas
Patos de Minas, Brazil
Hospital São Lucas - PUCRS
Porto Alegre, Brazil
Hospital Moinhos de Vento
Porto Alegre, Brazil
Hospital Mãe De Deus
Porto Alegre, Brazil
Clinica Status Cor
Rio de Janeiro, Brazil
Hospital Naval Marcíllo Dias
rio de Janeiro, Brazil
Fundação Bahiana de Cardiologia (MC Oliveira Prest
Salvador, Brazil
Hospital Beneficencia Portuguesa de Sao Paulo
Sao Joao do Paraiso, Brazil
Casa de Saude Santa Marcelina
Sao Paulo, Brazil
Hospital Albert Einstein
Sao Paulo, Brazil
Hospital Bandeirantes
Sao Paulo, Brazil
Hospital Ana Costa (ENDOCOR Serviços Médicos Ltda)
Sao Vicente, Brazil
Instituto Dante Pazzanese
São Paulo, Brazil
Real e Benemérita Assoção Portuguesa de Beneficênc
São Paulo, Brazil
Hospital Anchieta Ltda.
Taguatinga, Brazil
Instituto do Coração do Triângulo Mineiro
Uberlândia, Brazil
Insituto de Cardiologia Espirito Santo
Vitória, Brazil
Bulgaria
Tokuda Hospital Sofia
Sofia, Bulgaria
Chile
Hospital Militar de Santiago
La Reina, Chile
San Juan de Dios
Santiago, Chile
Instituto Nacional del Torax
Santiago, Chile
clinica Santa Maria
Santiago de Chile, Chile
Las Higueras De Talcahuano
Talcahuano, Chile
V Region (Hospital Gustavo Fricke, Hospital Van Buren, Clinica Reñaca)
Valparaíso, Chile
Clinica alemana de Santiago
Vitacura, Chile
Czech Republic
St. Anne University Hospital
Brno, Czech Republic
Nemocnice Na Homolce
Praha, Czech Republic, 15030
Denmark
Gentofte Hospital (M12FU)
Hellerup, Denmark
Egypt
ALHYATT Cardiovascular Center
Alexandria, Egypt
International Cardiac Center
Alexandria, Egypt
El Dorah Heart Care Center
Cairo, Egypt
Al Nakhil hospital
Cairo, Egypt
AS-Salam Mohndseen
Cairo, Egypt
Cleopatra
Cairo, Egypt
Egyheart - cath lab
Cairo, Egypt
Hayat Hospital
Cairo, Egypt
AL Amal
Cairo, Egypt
Glory cardiac center - Cath group
Dakahlia, Egypt
ICS center
Egypt, Egypt
Om El kora cardiac center
Gharbia, Egypt
RCC Cardiac center
Giza, Egypt
Alfa
Giza, Egypt
(DAFH) Dar Al Fouad Hospital
Giza, Egypt
Al Noor Cath Lab
Sohag, Egypt
Estonia
East Tallinn Central Hospital
Tallin, Estonia
North-Estonia Regional Hospital
Tallin, Estonia
France
Clinique de l'Europe à Amiens (SAS Cardio Amiens)
Amiens, France
CHU Angers
Angers, France
Hôpital Privé d'Antony
Anthony, France
Hopital La Roseraie
Aubervilliers, France
CH Avignon
Avignon, France
Clinique Rhone Durance
Avignon, France
CH Bastia
Bastia Cedex, France
Clinique La Fourcade
Bayonne, France
Clinique Bois Bernard à Bois Bernard
Bois-Bernard, France
Clinique Saint Augustin
Bordeaux, France
CHU de la Cavale Blanche
Brest, France
CH Privé Saint - Martin Caen
Caen, France
CHU de la Cote de Nacre (CHU Caen)
Caen, France
Hopital Albert Schweitzer-Colmar
Colmar, France
CH Sud Francilien
Corbeil Essonnes, France
Clinique des Cèdres-Dr Brunelle
Cornebarrieu, France
Clinique des Cèdres-Dr.Tauzin
Cornebarrieu, France
Centre Cardiologique d'Evecquemont
Evecquemont, France
CH Haguenau
Hagueneau cedex, France
CH de Lagny-Marne La Vallée
Jossigny, France
CH de Cornouaille
La Cornuaille, France
CH La Roche sur Yon
La Roche sur Yon, France
CH de Chartres
Le Coudray, France
CC Marie Lannelongue
Le Plessis Robinson, France
Clinique La Louviere
Lille, France
CH Dupuytren Limoges
Limoges Cedex, France
CH Lorient
Lorient, France
Institut Hospitalier Jacques Cartier (ICPS Massy)
Massy, France
Clinique les Fontaines
Melun, France
Clinique du Millenaire
Montpellier, France
Hôpital Europeen Georges Pompidou (HEGP)
Paris, France
Clinique Turin - Paris
Paris, France
Hopital Lariboisière
Paris, France
Hopital Pitié Salpétrière
Paris, France
Hôpital du Val de Grâce
Paris, France
Association Clinique Bizet
Paris, France
CH Pau
Pau, France
CH Périgueux
Perigueux, France
CH Général Maréchal Joffre Perpignan
Perpignan, France
Clinique Saint-Martin Pessac
Pessac, France
CHU La Miletrie Poitiers
Poitiers, France
CH René Dubos
Pontoise, France
Hopital Claude Galien
Quincy, France
Clinique Saint Laurent
Rennes, France
Hôpital Jacques Puel (CH de Rodez)
Rodez, France
Clinique Saint Hilaire
Rouen, France
Centre Cardiologique du Nord
Saint Denis, France
NHC Strasbourg
Strasbourg, France
Clinique de l'Ormeau - CCV des Pyrenées
Tarbes, France
Polyclinique du Parc Toulouse
Toulouse, France
CH Valence
Valence, France
Clinique Vauban
Valenciennes, France
CH Bretagne Atlantique
Vannes, France
Georgia
JoAnn Medical Center
Tbilisi, Georgia
Germany
Zentralklinik Bad Berka GmbH
Bad Berka, Germany
Herz-und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, Germany
Vivantes Netzwerk für Gesundheit gmbH - Friedrichs
Berlin, Germany
Gemeinschaftskrankenhaus Havelhöhe
Berlin, Germany
Jüdisches Krankenhaus
Berlin, Germany
Klinikum Neukölln
Berlin, Germany
Vivantes Klinkum Spandau
Berlin, Germany
Vivantes Netzwerk für Gesundheit gmbH - Am Urban
Berlin, Germany
Evangelisch Freikirchliches Krankenhaus und Herzze
Berlin, Germany
Vivantes Netzwerk für Gesundheit gmbH - Humboldt
Berlin, Germany
Ev.Bethesda-Johanniter Klinikum Duisburg GmbH
Duisburg, Germany
Klinikum Fulda
Fulda, Germany
Uniklinik Schleswig-Holstein, Campus Kiel
Kiel, Germany
Herzzentrum Leipzig-Rhöne Klinikum
Leipzig, Germany
St. Marienhospital Lünen
Lünen, Germany
Klinikum Oldenburg
Oldenburg, Germany
Universitätsklinik Rostock
Rostock, Germany
Evang.Diakonieanstalt Speyer
Speyer, Germany
Hungary
Gottsegen National Cardiology Institute (GOKI)
Budapest, Hungary
Semmelweis University Cardiology Centre
Budapest, Hungary
Fejér Megyei Szent György Kórház
Székesfehérvár, Hungary
Indonesia
Medistra Hospital
Jakarta, Indonesia
National Cardiovascular Center Harapan Kita
Jakarta, Indonesia
Dr. Soetomo General Hospital, Surabaya
Surabaya, Indonesia
Ireland
Southern Health and Social Care Trust Craigavon Ar
Craigavon, Ireland
Beaumont Hospital
Dublin, Ireland
University Hospital Galway
Galway, Ireland
Israel
Rambam Medical centre
Haifa, Israel
Wolfson Medical Center
Holon, Israel, 58100
Meir Medical Center, Kfar-Saba
Kfar-Saba, Israel
Laniado Medical Center
Netanya, Israel
Rabin Medical Center
Petah Tikva, Israel
Kaplan Hospital
Rehovot, Israel
Latvia
Invasive Cardiology Laboratory of Clinics "Gailezers" of Riga's Eastern Clinical University Hospital
Riga, Latvia
Invasive Cardiology Laboratory of P. Stradins Clinical University Hospital
Riga, Latvia
Lithuania
Hospital of Lithuania University of Health Science
Kaunas, Lithuania
Malta
Mater Dei
Msida, Malta
Mexico
1e de Octubre ISSSTE
Ciudad de Mexico, Mexico
Hospital Angeles Culiacan
Culiacán, Mexico
Hospital Angeles Leon
León, Guanajuato, Mexico
Hospital Star Medica Mérida Yucatán
Merida, Yucatan, Mexico
Hospital Central Militar
Mexico City, Mexico
Hospital Angeles Mocel
Mexico DF, Mexico
Hospital de Cardiologia C.M.N.
Mexico DF, Mexico
Instituto Nacional De Cardiologia "Ignacio Chávez"
Mexico DF, Mexico
Centro Médico Nacional 20 de Noviembre
Mexico, D.F., Mexico
Hospital Universitario Dr. José Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico
Dalinde Medical Center
México, DF, Mexico
Hospital Lomas de San Luis Internacional
San Luis Potosi SLP, Mexico
Netherlands
Amphia Hospital
Breda, Netherlands
Medisch Centrum Haaglanden
Den Haag, Netherlands
Albert Schweitzer Hospital
Dordrecht, Netherlands
Jeroen Bosch Ziekenhuis
s'Hertogenbosch, Netherlands
Poland
St Adalbert Speciality Hospital
Gdansk, Poland
Szpital Wojewodzski Poznaniu
Poznan, Poland
Szpital Klinicznk Przemienienia (University Hospital)
Poznan, Poland
Romania
Cardiolife Hospital Timisoara
Timisoara, Romania, 300014
Russian Federation
Chelyabinsk Regional Clinical Hospital
Chelyabinsk, Russian Federation
Military Hospital N3 named by Vishnevsky
Krasnogorsk, Russian Federation
State cardiovascular center based on regional clin
Krasnoyarsk, Russian Federation
Regional Clinical Hospital
Kursk, Russian Federation
Central Clinical Hospital N°2 Russia Railways
Moscow, Russian Federation
Academian E.N Meshalkin State Research Institute of circulation Pathology
Novosibirsk, Russian Federation, 630055
Federal cardiosurgerical center, Penza
Penza, Russian Federation
Federal center of heart,blood and endocrinology diseases named by Almazov
Saint-Petersburg, Russian Federation
Saratov Research Institute of science for cardiology
Saratov, Russian Federation
Kirochnaya str.41
St-Petersburg, Russian Federation, 191015
Regional Vessel Center
Ufa, Russian Federation
Ufa city Emergency Hospital
Ufa, Russian Federation
Serbia
Institute for Cardiovascular Disease Dedinje
Dedinje, Serbia
Clinical Center Kragujevac
Kragujevac, Serbia
Clinical Center of Niš
Niš, Serbia
Slovenia
CH Celje
Celje, Slovenia
Spain
Hospital general de Albacete
Albacete, Spain
Hospital San Juan
Alicante, Spain
Hospital Torrecárdenas
Almeria, Spain
Hospital G. Trias i Pujol
Badalona, Spain
Hospital Bellvitge
Barcelona, Spain
Hospital Sant Pau
Barcelona, Spain
Hospital de Cruces-Barakaldo
Bilbao- Vizcaya, Spain
Hospital de Galdakao
Bizkaia, Spain
Hospital San Pedro de Alcantara-Caceres
Caceres, Spain
Hospital Nostra Señora Rossell
Cartagena, Spain
Hospital General de Castellón
Castellón, Spain
Hospital Nostra Señora Alarcos
Ciudad Real, Spain
Hospital Cabueñes
Gijón, Spain
Hospital Universitario de Guadalajara
Guadalajara, Spain
Hospital Juan Canalejo
La Coruña, Spain
Hospital San Rafael
La Coruña, Spain
Clinica San Roque
Las Palmas, Spain
Hospital de León
León, Spain
Clínica Moncloa
Madrid, Spain
Hospital Fundacion Alcorcon
Madrid, Spain
Hospital Puerta de Hierro
Majadahonda-Madrid, Spain
Hospital Virgen Arrixaca
Murcia, Spain
Universitario central de Asturias
Oviedo, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Spain
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, Spain
Hospital Candelaria
Tenerife, Spain
Hospital Virgen Salud
Toledo, Spain
Clínico Universitario Valencia
Valencia, Spain
Hospital Manises
Valencia, Spain
Hospital Meixoeiro-MEDTEC
Vigo, Spain
Hospital Txagorritxu
Vitoria, Spain
Hospital Miguel Servet
Zaragoza, Spain
Sweden
Falun Lasarett
Falun, Sweden
University Hospital Linköping
Linköping, Sweden
Uppsala Akademiska Sjukhus, Kardiologkliniken
Uppsala, Sweden
Central Lasarettet i Västerås, Angio/PCI lab. Medi
Västerås, Sweden
Taiwan
E-da Hospital/Kaohsiung
Kaohsiung, Taiwan
Taichung Veterans General Hospital
Taichung R.O.C., Taiwan
Chi Mei Medical Center/Tainan
Tainan, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Cheng Hsin General Hospital / Taipei
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital, VACRS
Taipei, Taiwan
Ukraine
Kharkov Regional Hospital
Kharkov, Ukraine
Feofaniya
Kiev, Ukraine
Ukrainian Institute of Cardiology
Kiev, Ukraine
National Institute of Cardiovascular Surgery AMS
Kyiv, Ukraine
United Kingdom
Queen Elizabeth Birmingham
Birmingham, United Kingdom
Royal Cornwall hospital
Cornwall, United Kingdom
Castle Hill Hospital
Cottingham, United Kingdom
Scunthorpe general hospital
District of North East Lincolnshire, United Kingdom
Dorset county Hospital
Dorset, United Kingdom
Eastbourne General
Eastbourne, United Kingdom
Glenfield general hospital
Glenfield, United Kingdom
Conquest Hospital Hastings
Hastings, United Kingdom
Royal Blackpool hospital (Lancashire Heart Centre)
Lancashire, United Kingdom
Northwick Park
London, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Royal Gwent Hospital
Newport, United Kingdom
Fairfield General Hospital
North Manchester, United Kingdom
Kettering General Hospital
Northamptonshire, United Kingdom
Frimley Park Hospital NHS Foundation Trust
Surrey, United Kingdom
Pinderfield General Hospital
Wakefield, United Kingdom
New Cross Wolverhampton
Wednesfield, United Kingdom
Sponsors and Collaborators
Terumo Europe N.V.
Investigators
Study Chair: Dragica Paunovic, Dr. Terumo Europe
  More Information

Publications:
Grube E, Spirit V registry: one-year follow-up. EuroIntervention 2009; 5
Safian R.D. and Freed M., Complications. In: The Manual of Interventional Cardiology Jones & Bartlett Publishers, 2001. 381-467
Nakamura S, Nakamura S, Ogawa H, Bae JH, HansCahyadi Y, Udayachalerm W, DTresukosol D, Tansuphaswadikul S, Drug-eluting stents for the treatment of left main coronary artery disease with sirolimus, paclitaxel, zotarolimus, BiolimusA9, EPC capture and everolimus-eluting stent: multicenter registry in Asia (Oral Contributions Georgia World Congress Center, Room B315 Monday, March 15, 2010, 2:00 p.m.-2:12 p.m.). J Am Coll Cardiol 2010;55
Nakamura S, Nakamura S, Ogawa H, Bae JH, HansCahyadi Y, Udayachalerm W, DTresukosol D, Tansuphaswadikul S, Drug-eluting stents for the treatment of chronic total occlusion: a comparison with sirolimus, paclitaxel, zotarolimus, BiolimusA9, EPC capture and everolimus-eluting stent: multicenter registry in Asia (Poster Contributions Georgia World Congress Center, Hall B5 Monday, March 15, 2010, 9:30 a.m.-10:30 a.m. ). J Am Coll Cardiol 2010;55.

Responsible Party: Terumo Europe N.V.
ClinicalTrials.gov Identifier: NCT01261273     History of Changes
Other Study ID Numbers: T113E2
Study First Received: December 14, 2010
Last Updated: May 11, 2015
Health Authority: Hungary: National Institute of Pharmacy
Belarus: Ministry of Health
Brazil: Ethics Committee
Chile: Comité de Ética Científico
Estonia: Research Ethics Committee
France: Institutional Ethical Committee
Germany: Ethics Commission
Indonesia: Ethics Committee
Ireland: Research Ethics Committee
Israel: Ethics Commission
Latvia: Institutional Review Board
Lithuania: Bioethics Committee
Malta: Medicines Authority
Netherlands: Independent Ethics Committee
Pakistan: Research Ethics Committee
Slovenia: Ethics Committee
Spain: Comité Ético de Investigación Clínica
Sweden: Regional Ethical Review Board
Taiwan: Research Ethics Committee

Keywords provided by Terumo Europe N.V.:
PCI
observational registry

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 01, 2015