e-NOBORI Observational Registry of Nobori DES

Coronary Artery Disease Clinical Trial

— e-NOBORI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01261273
• Other study ID #: T113E2
• Status: Completed
• Start date: August 25, 2010
• Est. completion date: May 27, 2016

Study information

• Verified date: October 2019
• Source: Terumo Europe N.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18000
• Est. completion date: May 27, 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Terumo Europe N.V.

Countries where clinical trial is conducted

Austria,  Bangladesh,  Belarus,  Brazil,  Bulgaria,  Chile,  Czechia,  Denmark,  Egypt,  Estonia,  France,  Georgia,  Germany,  Hungary,  Indonesia,  Ireland,  Israel,  Latvia,  Lithuania,  Malta,  Mexico,  Netherlands,  Poland,  Romania,  Russian Federation,  Serbia,  Slovenia,  Spain,  Sweden,  Taiwan,  Ukraine,  United Kingdom, 

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* Note: There are 52 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FREEDOM OF TARGET LESION FAILURE	TLF: COMPOSITE OF CARDIAC DEATH, MYOCARDIAL INFARCTION AND TARGET LESION REVASCULARIZATION	1 YEAR
Secondary	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.	1 MONTH
Secondary	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.	1 MONTH
Secondary	Acute/subacute stent thrombosis	(definite/probable according to ARC definitions)	1 MONTH
Secondary	Peri-procedural myocardial infarction	Peri-procedural myocardial infarction	1 MONTH
Secondary	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)	1 MONTH
Secondary	Major vascular and bleeding complications	NOT CABG RELATED	1 MONTH
Secondary	Cardiac death/ Myocardial Infarction	Cardiac death/ Myocardial Infarction	1 AND 2 YEARS
Secondary	Clinically driven target lesion revascularization (TLR)	re-PCI or CABG involving target lesion	1 & 2 YEARS
Secondary	Stent thrombosis	(definite/probable; ARC definition)	1 AND 2 YEARS
Secondary	Clinically driven target vessel revascularization (TVR)	PCI AND CABG	1 AND 2 YEARS
Secondary	Target Lesion Failure (TLF)	Defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization	1 MONTH AND 2 YEARS
Secondary	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	1 MONTH, 1 AND 2 YEARS
Secondary	Composite Endpoint of Cardiac death and MI	Composite Endpoint of Cardiac death and MI	1 MONTH, 1 AND 2 YEARS
Secondary	Composite Endpoint of Cardiac death and post-procedural MI	Composite Endpoint of Cardiac death and post-procedural MI	1 month, 1 and 2 years post-procedure
Secondary	Stent thrombosis	definite and probable according to ARC definitions	1 month, 1 and 2 years post-procedure
Secondary	Primary Stent thrombosis	definite and probable according to ARC definitions	1 month, 1 and 2 years post-procedure
Secondary	Secondary Stent thrombosis	definite and probable according to ARC definitions	1 month, 1 and 2 years post-procedure
Secondary	Duration of dual antiplatelet therapy	Duration of dual antiplatelet therapy	UP TO 2 YEARS
Secondary	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	UP TO 2 YEARS
Secondary	Clinically driven Target Lesion Revascularization	Clinically driven Target Lesion Revascularization	1 MONTH
Secondary	Clinically driven Target Vessel Revascularization	Clinically driven Target Vessel Revascularization	1 MONTH