e-NOBORI Observational Registry of Nobori DES (e-NOBORI)

October 6, 2019 updated by: Terumo Europe N.V.

Prospective, Single-Arm, Multi-Centre, Observational Registry to Further Validate Safety and Efficacy of the Nobori DES in Real-World Patients

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

Study Overview

Status

Completed

Conditions

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)

Study Type

Observational

Enrollment (Actual)

18000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients suitable for PCI intervention

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FREEDOM OF TARGET LESION FAILURE
Time Frame: 1 YEAR
TLF: COMPOSITE OF CARDIAC DEATH, MYOCARDIAL INFARCTION AND TARGET LESION REVASCULARIZATION
1 YEAR

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural success
Time Frame: 1 MONTH
Procedural success is defined as achievement of a diameter of stenosis of <30% by visual assessment and/or <50% by QCA, using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesión during the hospital stay.
1 MONTH
Device success
Time Frame: 1 MONTH

Device Success defined as attainment of a final residual diameter stenosis of the target lesion of < 30% by visual assessment and/or < 50% by QCA, using the assigned device only.

Device Success defined as attainment of a final residual diameter stenosis of the target lesion of < 30% by visual assessment and/or < 50% by QCA, using the assigned device only.

Device success is defined as attainment of a final residual diameter stenosis of the target lesión of <30% by visual assessment and/or >50% QCA, using the assigned device only.
1 MONTH
Acute/subacute stent thrombosis
Time Frame: 1 MONTH
(definite/probable according to ARC definitions)
1 MONTH
Peri-procedural myocardial infarction
Time Frame: 1 MONTH
Peri-procedural myocardial infarction
1 MONTH
Rate of Major Adverse Cardiac Events (MACE)
Time Frame: 1 MONTH
Major Adverse Cardiac Events (MACE) defined as a composite of cardiac death, MI or clinically driven target vessel revascularization (TVR)
1 MONTH
Major vascular and bleeding complications
Time Frame: 1 MONTH
NOT CABG RELATED
1 MONTH
Cardiac death/ Myocardial Infarction
Time Frame: 1 AND 2 YEARS
Cardiac death/ Myocardial Infarction
1 AND 2 YEARS
Clinically driven target lesion revascularization (TLR)
Time Frame: 1 & 2 YEARS
re-PCI or CABG involving target lesion
1 & 2 YEARS
Stent thrombosis
Time Frame: 1 AND 2 YEARS
(definite/probable; ARC definition)
1 AND 2 YEARS
Clinically driven target vessel revascularization (TVR)
Time Frame: 1 AND 2 YEARS
PCI AND CABG
1 AND 2 YEARS
Target Lesion Failure (TLF)
Time Frame: 1 MONTH AND 2 YEARS
Defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization
1 MONTH AND 2 YEARS
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
Patient Oriented Composite Endpoint defined as any cause of mortality, MI (Q-wave and non Q-wave), or any TVR
1 MONTH, 1 AND 2 YEARS
Composite Endpoint of Cardiac death and MI
Time Frame: 1 MONTH, 1 AND 2 YEARS
Composite Endpoint of Cardiac death and MI
1 MONTH, 1 AND 2 YEARS
Composite Endpoint of Cardiac death and post-procedural MI
Time Frame: 1 month, 1 and 2 years post-procedure
Composite Endpoint of Cardiac death and post-procedural MI
1 month, 1 and 2 years post-procedure
Stent thrombosis
Time Frame: 1 month, 1 and 2 years post-procedure
definite and probable according to ARC definitions
1 month, 1 and 2 years post-procedure
Primary Stent thrombosis
Time Frame: 1 month, 1 and 2 years post-procedure
definite and probable according to ARC definitions
1 month, 1 and 2 years post-procedure
Secondary Stent thrombosis
Time Frame: 1 month, 1 and 2 years post-procedure
definite and probable according to ARC definitions
1 month, 1 and 2 years post-procedure
Duration of dual antiplatelet therapy
Time Frame: UP TO 2 YEARS
Duration of dual antiplatelet therapy
UP TO 2 YEARS
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
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
UP TO 2 YEARS
Clinically driven Target Lesion Revascularization
Time Frame: 1 MONTH
Clinically driven Target Lesion Revascularization
1 MONTH
Clinically driven Target Vessel Revascularization
Time Frame: 1 MONTH
Clinically driven Target Vessel Revascularization
1 MONTH

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Terumo Europe N.V.

Investigators

  • Study Chair: Dragica Paunovic, Dr., Terumo Europe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2010

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 27, 2016

Study Registration Dates

First Submitted

December 14, 2010

First Submitted That Met QC Criteria

December 14, 2010

First Posted (Estimate)

December 16, 2010

Study Record Updates

Last Update Posted (Actual)

October 9, 2019

Last Update Submitted That Met QC Criteria

October 6, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T113E2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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