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AzTrials

Coronary Artery Diseasee-NOBORINCT01261273

e-NOBORI Observational Registry of Nobori DES

An observational study of Coronary Artery Disease, run by Terumo Europe N.V. at 257 sites in 32 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
How many people
18,000 participants
Where
257 sitesin 32 countries
Study dates
25 Aug 2010to 27 May 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients suitable for PCI intervention

Who may be able to join

  • 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.

Who cannot join

  • None

Trial locations and contacts

257 sites in 32 countries.

257 sites in 32 countries

France53 sites

  • Clinique de l'Europe à Amiens (SAS Cardio Amiens)

    Amiens

  • CHU Angers

    Angers

  • Hôpital Privé d'Antony

    Antony

  • Hopital La Roseraie

    Aubervilliers

  • CH Avignon

    Avignon

  • Clinique Rhone Durance

    Avignon

  • CH Bastia

    Bastia

  • Clinique La Fourcade

    Bayonne

  • Clinique Bois Bernard à Bois Bernard

    Bois-Bernard

  • Clinique Saint Augustin

    Bordeaux

  • CHU de la Cavale Blanche

    Brest

  • CH Privé Saint - Martin Caen

    Caen

  • CHU de la Cote de Nacre (CHU Caen)

    Caen

  • Hopital Albert Schweitzer-Colmar

    Colmar

  • CH Sud Francilien

    Corbeil-Essonnes

  • Clinique des Cèdres-Dr Brunelle

    Cornebarrieu

  • Clinique des Cèdres-Dr.Tauzin

    Cornebarrieu

  • Centre Cardiologique d'Evecquemont

    Évecquemont

  • CH Haguenau

    Haguenau

  • CH de Lagny-Marne La Vallée

    Jossigny

  • CH de Cornouaille

    La Cornuaille

  • CH La Roche sur Yon

    La Roche-sur-Yon

  • CH de Chartres

    Le Coudray

  • CC Marie Lannelongue

    Le Plessis-Robinson

  • Clinique La Louviere

    Lille

  • CH Dupuytren Limoges

    Limoges

  • CH Lorient

    Lorient

  • Institut Hospitalier Jacques Cartier (ICPS Massy)

    Massy

  • Clinique les Fontaines

    Melun

  • Clinique du Millenaire

    Montpellier

  • Association Clinique Bizet

    Paris

  • Clinique Turin - Paris

    Paris

  • Hopital Lariboisière

    Paris

  • Hopital Pitié Salpétrière

    Paris

  • Hôpital du Val de Grâce

    Paris

  • Hôpital Europeen Georges Pompidou (HEGP)

    Paris

  • CH Pau

    Pau

  • CH Périgueux

    Périgueux

  • CH Général Maréchal Joffre Perpignan

    Perpignan

  • Clinique Saint-Martin Pessac

    Pessac

  • CHU La Miletrie Poitiers

    Poitiers

  • CH René Dubos

    Pontoise

  • Hopital Claude Galien

    Quincy

  • Clinique Saint Laurent

    Rennes

  • Hôpital Jacques Puel (CH de Rodez)

    Rodez

  • Clinique Saint Hilaire

    Rouen

  • Centre Cardiologique du Nord

    Saint-Denis

  • NHC Strasbourg

    Strasbourg

  • Clinique de l'Ormeau - CCV des Pyrenées

    Tarbes

  • Polyclinique du Parc Toulouse

    Toulouse

  • CH Valence

    Valence

  • Clinique Vauban

    Valenciennes

  • CH Bretagne Atlantique

    Vannes

Other trials in France

Brazil32 sites

  • Hospital Madre Teresa

    Belo Horizonte

  • Hospital Santa Isabel-Sociedade Divina Providência

    Blumenau

  • HMCP PUC-Campinas

    Campinas

  • Hospital E Maternidade Madre Teodora

    Campinas

  • Hospital Vera Cruz Campinas

    Campinas

  • Hospital Geral Universitário

    Cuiabá

  • Hospital Cruz Vermelha Brasileira Filial do Paraná

    Curitiba

  • Hospital Nossa Senhora das Graças

    Curitiba

  • Hospital Santa Cruz

    Curitiba

  • Hospital Monte Sinai (Juiz de Fora)

    Juiz de Fora

  • Instituto Cardiovascular de Linhares (Unicor)

    Linhares

  • Hospital do Coração de Londrina

    Londrina

  • Irmandade da Santa Casa de Misericórdia de Marília

    Marília

  • Hospital Paraná

    Maringá

  • Hospital Procordis

    Niterói

  • Hospital Vera Cruz Patos de Minas

    Patos de Minas

  • Hospital Moinhos de Vento

    Porto Alegre

  • Hospital Mãe De Deus

    Porto Alegre

  • Hospital São Lucas - PUCRS

    Porto Alegre

  • Clinica Status Cor

    Rio de Janeiro

  • Hospital Naval Marcíllo Dias

    Rio de Janeiro

  • Fundação Bahiana de Cardiologia (MC Oliveira Prest

    Salvador

  • Hospital Beneficencia Portuguesa de Sao Paulo

    São João do Paraíso

  • Casa de Saude Santa Marcelina

    São Paulo

  • Hospital Albert Einstein

    São Paulo

  • Hospital Bandeirantes

    São Paulo

  • Instituto Dante Pazzanese

    São Paulo

  • Real e Benemérita Assoção Portuguesa de Beneficênc

    São Paulo

  • Hospital Ana Costa (ENDOCOR Serviços Médicos Ltda)

    São Vicente

  • Hospital Anchieta Ltda.

    Taguatinga

  • Instituto do Coração do Triângulo Mineiro

    Uberlândia

  • Insituto de Cardiologia Espirito Santo

    Vitória

Other trials in Brazil

Spain32 sites

  • Hospital Juan Canalejo

    A Coruña

  • Hospital San Rafael

    A Coruña

  • Hospital general de Albacete

    Albacete

  • Hospital San Juan

    Alicante

  • Hospital Torrecárdenas

    Almería

  • Hospital G. Trias i Pujol

    Badalona

  • Hospital Bellvitge

    Barcelona

  • Hospital Sant Pau

    Barcelona

  • Hospital de Cruces-Barakaldo

    Bilbao- Vizcaya

  • Hospital de Galdakao

    Bizkaia

  • Hospital San Pedro de Alcantara-Caceres

    Cáceres

  • Hospital Nostra Señora Rossell

    Cartagena

  • Hospital General de Castellón

    Castellon

  • Hospital Nostra Señora Alarcos

    Ciudad Real

  • Hospital Cabueñes

    Gijón

  • Hospital Universitario de Guadalajara

    Guadalajara

  • Clinica San Roque

    Las Palmas

  • Hospital de León

    León

  • Clínica Moncloa

    Madrid

  • Hospital Fundacion Alcorcon

    Madrid

  • Hospital Puerta de Hierro

    Majadahonda-Madrid

  • Hospital Virgen Arrixaca

    Murcia

  • Universitario central de Asturias

    Oviedo

  • Hospital Clínico Universitario de Salamanca

    Salamanca

  • Hospital Candelaria

    Santa Cruz de Tenerife

  • Hospital Clínico Universitario de Santiago de Compostela

    Santiago de Compostela

  • Hospital Virgen Salud

    Toledo

  • Clínico Universitario Valencia

    Valencia

  • Hospital Manises

    Valencia

  • Hospital Meixoeiro-MEDTEC

    Vigo

  • Hospital Txagorritxu

    Vitoria-Gasteiz

  • Hospital Miguel Servet

    Zaragoza

Other trials in Spain

Germany18 sites

  • Zentralklinik Bad Berka GmbH

    Bad Berka

  • Herz-und Diabeteszentrum Nordrhein-Westfalen

    Bad Oeynhausen

  • Evangelisch Freikirchliches Krankenhaus und Herzze

    Berlin

  • Gemeinschaftskrankenhaus Havelhöhe

    Berlin

  • Jüdisches Krankenhaus

    Berlin

  • Klinikum Neukölln

    Berlin

  • Vivantes Klinkum Spandau

    Berlin

  • Vivantes Netzwerk für Gesundheit gmbH - Am Urban

    Berlin

  • Vivantes Netzwerk für Gesundheit gmbH - Friedrichs

    Berlin

  • Vivantes Netzwerk für Gesundheit gmbH - Humboldt

    Berlin

  • Ev.Bethesda-Johanniter Klinikum Duisburg GmbH

    Duisburg

  • Klinikum Fulda

    Fulda

  • Uniklinik Schleswig-Holstein, Campus Kiel

    Kiel

  • Herzzentrum Leipzig-Rhöne Klinikum

    Leipzig

  • St. Marienhospital Lünen

    Lünen

  • Klinikum Oldenburg

    Oldenburg

  • Universitätsklinik Rostock

    Rostock

  • Evang.Diakonieanstalt Speyer

    Speyer

Other trials in Germany

United Kingdom18 sites

  • Queen Elizabeth Birmingham

    Birmingham

  • Royal Blackpool hospital (Lancashire Heart Centre)

    Blackpool

  • Royal Cornwall hospital

    Cornwell

  • Castle Hill Hospital

    Cottingham

  • Southern Health and Social Care Trust Craigavon Ar

    Craigavon

  • Scunthorpe general hospital

    District of North East Lincolnshire

  • Dorset county Hospital

    Dorset

  • Eastbourne General

    Eastbourne

  • Glenfield general hospital

    Glenfield

  • Conquest Hospital Hastings

    Hastings

  • Kettering General Hospital

    Kettering

  • Northwick Park

    London

  • Freeman Hospital

    Newcastle upon Tyne

  • Royal Gwent Hospital

    Newport

  • Fairfield General Hospital

    North Manchester

  • Frimley Park Hospital NHS Foundation Trust

    Surrey

  • Pinderfield General Hospital

    Wakefield

  • New Cross Wolverhampton

    Wednesfield

Other trials in United Kingdom

Egypt16 sites

  • Glory cardiac center - Cath group

    Al Mansurah

  • ALHYATT Cardiovascular Center

    Alexandria

  • International Cardiac Center

    Alexandria

  • AL Amal

    Cairo

  • Al Nakhil hospital

    Cairo

  • AS-Salam Mohndseen

    Cairo

  • Cleopatra

    Cairo

  • Egyheart - cath lab

    Cairo

  • El Dorah Heart Care Center

    Cairo

  • Hayat Hospital

    Cairo

  • (DAFH) Dar Al Fouad Hospital

    Giza

  • Alfa

    Giza

  • ICS center

    Giza

  • RCC Cardiac center

    Giza

  • Al Noor Cath Lab

    Sohag

  • Om El kora cardiac center

    Tanta

Other trials in Egypt

Mexico12 sites

  • Hospital Angeles Culiacan

    Culiacán

  • Hospital Angeles Leon

    León, Guanajuato

  • Hospital Star Medica Mérida Yucatán

    Merida, Yucatan

  • 1e de Octubre ISSSTE

    Mexico City

  • Centro Médico Nacional 20 de Noviembre

    Mexico City

  • Hospital Angeles Mocel

    Mexico City

  • Hospital Central Militar

    Mexico City

  • Hospital de Cardiologia C.M.N.

    Mexico City

  • Instituto Nacional De Cardiologia "Ignacio Chávez"

    Mexico City

  • Dalinde Medical Center

    México, DF

  • Hospital Universitario Dr. José Eleuterio Gonzalez

    Monterrey, Nuevo León

  • Hospital Lomas de San Luis Internacional

    San Luis Potosi SLP

Other trials in Mexico

Russia12 sites

  • Chelyabinsk Regional Clinical Hospital

    Chelyabinsk

  • Military Hospital N3 named by Vishnevsky

    Krasnogorsk

  • State cardiovascular center based on regional clin

    Krasnoyarsk

  • Regional Clinical Hospital

    Kursk

  • Central Clinical Hospital N°2 Russia Railways

    Moscow

  • Academian E.N Meshalkin State Research Institute of circulation Pathology

    Novosibirsk, 630055

  • Federal cardiosurgerical center, Penza

    Penza

  • Kirochnaya str.41

    Saint Petersburg, 191015

  • Federal center of heart,blood and endocrinology diseases named by Almazov

    Saint Petersburg

  • Saratov Research Institute of science for cardiology

    Saratov

  • Regional Vessel Center

    Ufa

  • Ufa city Emergency Hospital

    Ufa

Other trials in Russia

Chile7 sites

  • Hospital Militar de Santiago

    La Reina

  • clinica Santa Maria

    Santiago

  • Instituto Nacional del Torax

    Santiago

  • San Juan de Dios

    Santiago

  • Las Higueras De Talcahuano

    Talcahuano

  • V Region (Hospital Gustavo Fricke, Hospital Van Buren, Clinica Reñaca)

    Valparaíso

  • Clinica alemana de Santiago

    Vitacura

Other trials in Chile

Taiwan7 sites

  • E-da Hospital/Kaohsiung

    Kaohsiung City

  • Taichung Veterans General Hospital

    Taichung R.o.c.

  • Chi Mei Medical Center/Tainan

    Tainan

  • National Cheng Kung University Hospital

    Tainan

  • Cheng Hsin General Hospital / Taipei

    Taipei

  • National Taiwan University Hospital

    Taipei

  • Taipei Veterans General Hospital, VACRS

    Taipei

Other trials in Taiwan

Israel6 sites

  • Rambam Medical centre

    Haifa

  • Wolfson Medical Center

    Holon, 58100

  • Meir Medical Center, Kfar-Saba

    Kfar Saba

  • Laniado Medical Center

    Netanya

  • Rabin Medical Center

    Petah Tikva

  • Kaplan Hospital

    Rehovot

Other trials in Israel

Netherlands4 sites

  • Amphia Hospital

    Breda

  • Albert Schweitzer Hospital

    Dordrecht

  • Jeroen Bosch Ziekenhuis

    s'Hertogenbosch

  • Medisch Centrum Haaglanden

    The Hague

Other trials in Netherlands

Sweden4 sites

  • Falun Lasarett

    Falun

  • University Hospital Linköping

    Linköping

  • Uppsala Akademiska Sjukhus, Kardiologkliniken

    Uppsala

  • Central Lasarettet i Västerås, Angio/PCI lab. Medi

    Västerås

Other trials in Sweden

Ukraine4 sites

  • Kharkov Regional Hospital

    Kharkiv

  • Feofaniya

    Kiev

  • Ukrainian Institute of Cardiology

    Kiev

  • National Institute of Cardiovascular Surgery AMS

    Kyiv

Other trials in Ukraine

Belarus3 sites

  • Republican Clinical Medical Center (Presidential Hospital)

    Minsk

  • Republican Scientific and Practical Center of Cardiology

    Minsk

  • Mogilev Regional Clinical Hospital

    Mogilev

Other trials in Belarus

Hungary3 sites

  • Gottsegen National Cardiology Institute (GOKI)

    Budapest

  • Semmelweis University Cardiology Centre

    Budapest

  • Fejér Megyei Szent György Kórház

    Székesfehérvár

Other trials in Hungary

Indonesia3 sites

  • Medistra Hospital

    Jakarta

  • National Cardiovascular Center Harapan Kita

    Jakarta

  • Dr. Soetomo General Hospital, Surabaya

    Surabaya

Other trials in Indonesia

Poland3 sites

  • St Adalbert Speciality Hospital

    Gdansk

  • Szpital Klinicznk Przemienienia (University Hospital)

    Poznan

  • Szpital Wojewodzski Poznaniu

    Poznan

Other trials in Poland

Serbia3 sites

  • Institute for Cardiovascular Disease Dedinje

    Dedinje

  • Clinical Center Kragujevac

    Kragujevac

  • Clinical Center of Niš

    Niš

Other trials in Serbia

Czechia2 sites

  • St. Anne University Hospital

    Brno

  • Nemocnice Na Homolce

    Prague, 15030

Other trials in Czechia

Estonia2 sites

  • East Tallinn Central Hospital

    Tallinn

  • North-Estonia Regional Hospital

    Tallinn

Other trials in Estonia

Ireland2 sites

  • Beaumont Hospital

    Dublin

  • University Hospital Galway

    Galway

Other trials in Ireland

Latvia2 sites

  • Invasive Cardiology Laboratory of Clinics "Gailezers" of Riga's Eastern Clinical University Hospital

    Riga

  • Invasive Cardiology Laboratory of P. Stradins Clinical University Hospital

    Riga

Other trials in Latvia

Austria1 site

  • SMZ-Donauspital Vienna

    Vienna

Other trials in Austria

Bangladesh1 site

  • National Heart Foundation Hospital & Research Institute

    Dhaka

Other trials in Bangladesh

Bulgaria1 site

  • Tokuda Hospital Sofia

    Sofia

Other trials in Bulgaria

Denmark1 site

  • Gentofte Hospital (M12FU)

    Hellerup

Other trials in Denmark

Georgia1 site

  • JoAnn Medical Center

    Tbilisi

Other trials in Georgia

Lithuania1 site

  • Hospital of Lithuania University of Health Science

    Kaunas

Other trials in Lithuania

Malta1 site

  • Mater Dei

    Msida

Other trials in Malta

Romania1 site

  • Cardiolife Hospital Timisoara

    Timișoara, 300014

Other trials in Romania

Slovenia1 site

  • CH Celje

    Celje

Other trials in Slovenia

About this study

Official title: 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

Read the 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)

Keywords
PCI, observational registry
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01261273
Study groupRoleWhat they receive
Stable anginaPatient admitted with stable angina
Acute Coronary SyndromePatients admitted with Acute Coronary Syndrome
FemaleParticipant female patients
BifurcationOne or more lesions treated during the baseline in bifurcation
Insulin Dependent Diabetes MellitusPatients that were insulin-dependent diabetes mellitus at admission
Non-Insulin Dependent Diabetes MellitusPatients that were non-insulin-dependent diabetes mellitus at admission
Small Vesselsvessels smaller or equal to 2.75mm
NOBORI Long LesionsLesions longer or equal to 20mm
Renal InsufficiencyPatients that at admission had renal insufficiency (> 2.0 mg/dL - 176 µmol/mL) at admission
ElderlyPatients more or equal 80 years old
RestenosisOne or more lesions treated during the baseline in were restenotic lesions
Multivessel TreatmentPatients who underwent the treatment of more than 1 vessel during the index procedure
Complex LesionsPatients who underwent a PCI on the Left Main Trunk, on a Chronic Total Occluded lesion or located on a Saphenous Vein Graft
OverallTotal Population

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FREEDOM OF TARGET LESION FAILURE

    TLF: COMPOSITE OF CARDIAC DEATH, MYOCARDIAL INFARCTION AND TARGET LESION REVASCULARIZATION

    Measured: 1 YEAR

Secondary outcomes (21)

  1. Procedural success

    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.

    Measured: 1 MONTH

  2. Device success

    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.

    Measured: 1 MONTH

  3. Acute/subacute stent thrombosis

    (definite/probable according to ARC definitions)

    Measured: 1 MONTH

  4. Peri-procedural myocardial infarction

    Peri-procedural myocardial infarction

    Measured: 1 MONTH

  5. Rate of Major Adverse Cardiac Events (MACE)

    Major Adverse Cardiac Events (MACE) defined as a composite of cardiac death, MI or clinically driven target vessel revascularization (TVR)

    Measured: 1 MONTH

  6. Major vascular and bleeding complications

    NOT CABG RELATED

    Measured: 1 MONTH

  7. Cardiac death/ Myocardial Infarction

    Cardiac death/ Myocardial Infarction

    Measured: 1 AND 2 YEARS

  8. Clinically driven target lesion revascularization (TLR)

    re-PCI or CABG involving target lesion

    Measured: 1 & 2 YEARS

  9. Stent thrombosis

    (definite/probable; ARC definition)

    Measured: 1 AND 2 YEARS

  10. Clinically driven target vessel revascularization (TVR)

    PCI AND CABG

    Measured: 1 AND 2 YEARS

  11. Target Lesion Failure (TLF)

    Defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization

    Measured: 1 MONTH AND 2 YEARS

  12. Patient Oriented Composite Endpoint defined as any cause of mortality, MI (Q-wave and non Q-wave), or any TVR

    Patient Oriented Composite Endpoint defined as any cause of mortality, MI (Q-wave and non Q-wave), or any TVR

    Measured: 1 MONTH, 1 AND 2 YEARS

  13. Composite Endpoint of Cardiac death and MI

    Composite Endpoint of Cardiac death and MI

    Measured: 1 MONTH, 1 AND 2 YEARS

  14. Composite Endpoint of Cardiac death and post-procedural MI

    Composite Endpoint of Cardiac death and post-procedural MI

    Measured: 1 month, 1 and 2 years post-procedure

  15. Stent thrombosis

    definite and probable according to ARC definitions

    Measured: 1 month, 1 and 2 years post-procedure

  16. Primary Stent thrombosis

    definite and probable according to ARC definitions

    Measured: 1 month, 1 and 2 years post-procedure

  17. Secondary Stent thrombosis

    definite and probable according to ARC definitions

    Measured: 1 month, 1 and 2 years post-procedure

  18. Duration of dual antiplatelet therapy

    Duration of dual antiplatelet therapy

    Measured: UP TO 2 YEARS

  19. 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

    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

    Measured: UP TO 2 YEARS

  20. Clinically driven Target Lesion Revascularization

    Clinically driven Target Lesion Revascularization

    Measured: 1 MONTH

  21. Clinically driven Target Vessel Revascularization

    Clinically driven Target Vessel Revascularization

    Measured: 1 MONTH

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2010 (estimated)
  2. Study start25 Aug 2010
  3. Primary completionMay 2016
  4. Study completion27 May 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
18,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01261273
Sponsor's protocol ID
T113E2
Acronym
e-NOBORI
Status last verified
Oct 2019
First submitted
14 Dec 2010
Last updated
9 Oct 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med. 1987 Mar 19;316(12):701-6. doi: 10.1056/NEJM198703193161201.

    PubMed 2950322

  • Detre KM, Holmes DR Jr, Holubkov R, Cowley MJ, Bourassa MG, Faxon DP, Dorros GR, Bentivoglio LG, Kent KM, Myler RK. Incidence and consequences of periprocedural occlusion. The 1985-1986 National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry. Circulation. 1990 Sep;82(3):739-50. doi: 10.1161/01.cir.82.3.739.

    PubMed 2394000

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Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Terumo Europe N.V. at 257 sites in 32 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 257 sites in France, Brazil, Spain, Germany, United Kingdom and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FREEDOM OF TARGET LESION FAILURE (time frame: 1 YEAR). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01261273, which also lists 52 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.

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