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.
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
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
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
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
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
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
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
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
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
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
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
Netherlands4 sites
Amphia Hospital
Breda
Albert Schweitzer Hospital
Dordrecht
Jeroen Bosch Ziekenhuis
s'Hertogenbosch
Medisch Centrum Haaglanden
The Hague
Sweden4 sites
Falun Lasarett
Falun
University Hospital Linköping
Linköping
Uppsala Akademiska Sjukhus, Kardiologkliniken
Uppsala
Central Lasarettet i Västerås, Angio/PCI lab. Medi
Västerås
Ukraine4 sites
Kharkov Regional Hospital
Kharkiv
Feofaniya
Kiev
Ukrainian Institute of Cardiology
Kiev
National Institute of Cardiovascular Surgery AMS
Kyiv
Belarus3 sites
Republican Clinical Medical Center (Presidential Hospital)
Minsk
Republican Scientific and Practical Center of Cardiology
Minsk
Mogilev Regional Clinical Hospital
Mogilev
Hungary3 sites
Gottsegen National Cardiology Institute (GOKI)
Budapest
Semmelweis University Cardiology Centre
Budapest
Fejér Megyei Szent György Kórház
Székesfehérvár
Indonesia3 sites
Medistra Hospital
Jakarta
National Cardiovascular Center Harapan Kita
Jakarta
Dr. Soetomo General Hospital, Surabaya
Surabaya
Poland3 sites
St Adalbert Speciality Hospital
Gdansk
Szpital Klinicznk Przemienienia (University Hospital)
Poznan
Szpital Wojewodzski Poznaniu
Poznan
Serbia3 sites
Institute for Cardiovascular Disease Dedinje
Dedinje
Clinical Center Kragujevac
Kragujevac
Clinical Center of Niš
Niš
Czechia2 sites
St. Anne University Hospital
Brno
Nemocnice Na Homolce
Prague, 15030
Estonia2 sites
East Tallinn Central Hospital
Tallinn
North-Estonia Regional Hospital
Tallinn
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
Bangladesh1 site
National Heart Foundation Hospital & Research Institute
Dhaka
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)
- Conditions
- Coronary Artery Disease
- 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 group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
FREEDOM OF TARGET LESION FAILURE
TLF: COMPOSITE OF CARDIAC DEATH, MYOCARDIAL INFARCTION AND TARGET LESION REVASCULARIZATION
Measured: 1 YEAR
Secondary outcomes (21)
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
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
Acute/subacute stent thrombosis
(definite/probable according to ARC definitions)
Measured: 1 MONTH
Peri-procedural myocardial infarction
Peri-procedural myocardial infarction
Measured: 1 MONTH
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
Major vascular and bleeding complications
NOT CABG RELATED
Measured: 1 MONTH
Cardiac death/ Myocardial Infarction
Cardiac death/ Myocardial Infarction
Measured: 1 AND 2 YEARS
Clinically driven target lesion revascularization (TLR)
re-PCI or CABG involving target lesion
Measured: 1 & 2 YEARS
Stent thrombosis
(definite/probable; ARC definition)
Measured: 1 AND 2 YEARS
Clinically driven target vessel revascularization (TVR)
PCI AND CABG
Measured: 1 AND 2 YEARS
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
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
Composite Endpoint of Cardiac death and MI
Composite Endpoint of Cardiac death and MI
Measured: 1 MONTH, 1 AND 2 YEARS
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
Stent thrombosis
definite and probable according to ARC definitions
Measured: 1 month, 1 and 2 years post-procedure
Primary Stent thrombosis
definite and probable according to ARC definitions
Measured: 1 month, 1 and 2 years post-procedure
Secondary Stent thrombosis
definite and probable according to ARC definitions
Measured: 1 month, 1 and 2 years post-procedure
Duration of dual antiplatelet therapy
Duration of dual antiplatelet therapy
Measured: 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
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
Clinically driven Target Lesion Revascularization
Clinically driven Target Lesion Revascularization
Measured: 1 MONTH
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.
- First posted16 Dec 2010 (estimated)
- Study start25 Aug 2010
- Primary completionMay 2016
- Study completion27 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Terumo Europe N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dragica Paunovic, Dr., Study chair, Terumo Europe
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 2950322Detre 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 2394000Holmes DR Jr, Holubkov R, Vlietstra RE, Kelsey SF, Reeder GS, Dorros G, Williams DO, Cowley MJ, Faxon DP, Kent KM, et al. Comparison of complications during percutaneous transluminal coronary angioplasty from 1977 to 1981 and from 1985 to 1986: the National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry. J Am Coll Cardiol. 1988 Nov;12(5):1149-55. doi: 10.1016/0735-1097(88)92593-4.
PubMed 2971699Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med. 1994 Aug 25;331(8):496-501. doi: 10.1056/NEJM199408253310802.
PubMed 8041414Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489-95. doi: 10.1056/NEJM199408253310801.
PubMed 8041413Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.
PubMed 12050336Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabate M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Juni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007 Sep 15;370(9591):937-48. doi: 10.1016/S0140-6736(07)61444-5.
PubMed 17869634Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003 Oct 2;349(14):1315-23. doi: 10.1056/NEJMoa035071.
PubMed 14523139Holmes DR Jr, Leon MB, Moses JW, Popma JJ, Cutlip D, Fitzgerald PJ, Brown C, Fischell T, Wong SC, Midei M, Snead D, Kuntz RE. Analysis of 1-year clinical outcomes in the SIRIUS trial: a randomized trial of a sirolimus-eluting stent versus a standard stent in patients at high risk for coronary restenosis. Circulation. 2004 Feb 10;109(5):634-40. doi: 10.1161/01.CIR.0000112572.57794.22.
PubMed 14769686Grube E, Silber S, Hauptmann KE, Mueller R, Buellesfeld L, Gerckens U, Russell ME. TAXUS I: six- and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions. Circulation. 2003 Jan 7;107(1):38-42. doi: 10.1161/01.cir.0000047700.58683.a1.
PubMed 12515740Chevalier B, Serruys PW, Silber S, Garcia E, Suryapranata H, Hauptmann K, Wijns W, Schuler G, Fath-Ordoubadi F, Worthley S, Thuesen L, Meredith I, Bressers M, Nagai H, Paunovic D. Randomised comparison of Nobori, biolimus A9-eluting coronary stent with a Taxus(R), paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: the Nobori 1 trial. EuroIntervention. 2007 Feb;2(4):426-34.
PubMed 19755281Ostojic M, Sagic D, Beleslin B, Jung R, Perisic Z, Jagic N, Nedeljkovic M, Mangovski L, Milosavljevic B, Stojkovic S, Orlic D, Antonic Z, Miloradovic V, Topic D, Paunovic D. First clinical comparison of Nobori -Biolimus A9 eluting stents with Cypher- Sirolimus eluting stents: Nobori Core nine months angiographic and one year clinical outcomes. EuroIntervention. 2008 Mar;3(5):574-9. doi: 10.4244/eijv3i5a103.
PubMed 19608483Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA. 2005 May 4;293(17):2126-30. doi: 10.1001/jama.293.17.2126.
PubMed 15870416Chevalier B, Silber S, Park SJ, Garcia E, Schuler G, Suryapranata H, Koolen J, Hauptmann KE, Wijns W, Morice MC, Carrie D, van Es GA, Nagai H, Detiege D, Paunovic D, Serruys PW; NOBORI 1 Clinical Investigators. Randomized comparison of the Nobori Biolimus A9-eluting coronary stent with the Taxus Liberte paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: the NOBORI 1 trial--Phase 2. Circ Cardiovasc Interv. 2009 Jun;2(3):188-95. doi: 10.1161/CIRCINTERVENTIONS.108.823443. Epub 2009 May 8.
PubMed 20031715Jain AK, Meredith IT, Lotan C, Rothman MT, Pateraki S; E-Five Investigators. Real-world safety and efficacy of the endeavor zotarolimus-eluting stent: early data from the E-Five Registry. Am J Cardiol. 2007 Oct 22;100(8B):77M-83M. doi: 10.1016/j.amjcard.2007.08.026.
PubMed 17950836
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-Arm, Multi-Centre, Observational Registry to Further Validate Safety and Efficacy of the Nobori DES in Real-World Patients
- ClinicalTrials.gov ID
- NCT01261273
- Acronym / sponsor ID
- e-NOBORI / T113E2
- Conditions
- Coronary Artery Disease
- Keywords
- PCI, observational registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18,000 participants (actual)
- Lead sponsor
- Terumo Europe N.V.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2010 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- 27 May 2016 (actual)
- First posted
- 16 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suitable for PCI intervention
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
FREEDOM OF TARGET LESION FAILURE
Time frame: 1 YEAR
TLF: COMPOSITE OF CARDIAC DEATH, MYOCARDIAL INFARCTION AND TARGET LESION REVASCULARIZATION
21 secondary outcomes
Procedural success
Time frame: 1 MONTH
Device success
Time frame: 1 MONTH
Acute/subacute stent thrombosis
Time frame: 1 MONTH
Peri-procedural myocardial infarction
Time frame: 1 MONTH
Rate of Major Adverse Cardiac Events (MACE)
Time frame: 1 MONTH
Major vascular and bleeding complications
Time frame: 1 MONTH
Cardiac death/ Myocardial Infarction
Time frame: 1 AND 2 YEARS
Clinically driven target lesion revascularization (TLR)
Time frame: 1 & 2 YEARS
Stent thrombosis
Time frame: 1 AND 2 YEARS
Clinically driven target vessel revascularization (TVR)
Time frame: 1 AND 2 YEARS
Target Lesion Failure (TLF)
Time frame: 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
Composite Endpoint of Cardiac death and MI
Time frame: 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
Stent thrombosis
Time frame: 1 month, 1 and 2 years post-procedure
Primary Stent thrombosis
Time frame: 1 month, 1 and 2 years post-procedure
Secondary Stent thrombosis
Time frame: 1 month, 1 and 2 years post-procedure
Duration of dual antiplatelet therapy
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
Time frame: UP TO 2 YEARS
Clinically driven Target Lesion Revascularization
Time frame: 1 MONTH
Clinically driven Target Vessel Revascularization
Time frame: 1 MONTH
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Background: PubMed 2950322Sigwart 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.
- Background: PubMed 2394000Detre 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.
- Background: PubMed 2971699Holmes DR Jr, Holubkov R, Vlietstra RE, Kelsey SF, Reeder GS, Dorros G, Williams DO, Cowley MJ, Faxon DP, Kent KM, et al. Comparison of complications during percutaneous transluminal coronary angioplasty from 1977 to 1981 and from 1985 to 1986: the National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry. J Am Coll Cardiol. 1988 Nov;12(5):1149-55. doi: 10.1016/0735-1097(88)92593-4.
- Background: PubMed 8041414Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med. 1994 Aug 25;331(8):496-501. doi: 10.1056/NEJM199408253310802.
- Background: PubMed 8041413Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489-95. doi: 10.1056/NEJM199408253310801.
- Background: PubMed 12050336Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.
- Background: PubMed 17869634Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabate M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Juni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007 Sep 15;370(9591):937-48. doi: 10.1016/S0140-6736(07)61444-5.
- Background: PubMed 14523139Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003 Oct 2;349(14):1315-23. doi: 10.1056/NEJMoa035071.
- Background: PubMed 14769686Holmes DR Jr, Leon MB, Moses JW, Popma JJ, Cutlip D, Fitzgerald PJ, Brown C, Fischell T, Wong SC, Midei M, Snead D, Kuntz RE. Analysis of 1-year clinical outcomes in the SIRIUS trial: a randomized trial of a sirolimus-eluting stent versus a standard stent in patients at high risk for coronary restenosis. Circulation. 2004 Feb 10;109(5):634-40. doi: 10.1161/01.CIR.0000112572.57794.22.
- Background: PubMed 12515740Grube E, Silber S, Hauptmann KE, Mueller R, Buellesfeld L, Gerckens U, Russell ME. TAXUS I: six- and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions. Circulation. 2003 Jan 7;107(1):38-42. doi: 10.1161/01.cir.0000047700.58683.a1.
- Background: PubMed 19755281Chevalier B, Serruys PW, Silber S, Garcia E, Suryapranata H, Hauptmann K, Wijns W, Schuler G, Fath-Ordoubadi F, Worthley S, Thuesen L, Meredith I, Bressers M, Nagai H, Paunovic D. Randomised comparison of Nobori, biolimus A9-eluting coronary stent with a Taxus(R), paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: the Nobori 1 trial. EuroIntervention. 2007 Feb;2(4):426-34.
- Background: PubMed 19608483Ostojic M, Sagic D, Beleslin B, Jung R, Perisic Z, Jagic N, Nedeljkovic M, Mangovski L, Milosavljevic B, Stojkovic S, Orlic D, Antonic Z, Miloradovic V, Topic D, Paunovic D. First clinical comparison of Nobori -Biolimus A9 eluting stents with Cypher- Sirolimus eluting stents: Nobori Core nine months angiographic and one year clinical outcomes. EuroIntervention. 2008 Mar;3(5):574-9. doi: 10.4244/eijv3i5a103.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dragica Paunovic, Dr. study chair
Terumo Europe
257 sites in 32 countries: see every site and its status.
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; AzTrials last refreshed its copy on 7 Nov 2026.