e-NOBORI Observational Registry of Nobori DES
e-NOBORI
Prospective, Single-Arm, Multi-Centre, Observational Registry to Further Validate Safety and Efficacy of the Nobori DES in Real-World Patients
1 other identifier
observational
18,000
30 countries
251
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2010
Longer than P75 for all trials
251 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 25, 2010
CompletedFirst Submitted
Initial submission to the registry
December 14, 2010
CompletedFirst Posted
Study publicly available on registry
December 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 27, 2016
CompletedOctober 9, 2019
October 1, 2019
5.7 years
December 14, 2010
October 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
FREEDOM OF TARGET LESION FAILURE
TLF: COMPOSITE OF CARDIAC DEATH, MYOCARDIAL INFARCTION AND TARGET LESION REVASCULARIZATION
1 YEAR
Secondary Outcomes (21)
Procedural success
1 MONTH
Device success
1 MONTH
Acute/subacute stent thrombosis
1 MONTH
Peri-procedural myocardial infarction
1 MONTH
Rate of Major Adverse Cardiac Events (MACE)
1 MONTH
- +16 more secondary outcomes
Study Arms (14)
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
Eligibility Criteria
Patients suitable for PCI intervention
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (257)
SMZ-Donauspital Vienna
Vienna, Austria
National Heart Foundation Hospital & Research Institute
Dhaka, Bangladesh
Republican Clinical Medical Center (Presidential Hospital)
Minsk, Belarus
Republican Scientific and Practical Center of Cardiology
Minsk, Belarus
Mogilev Regional Clinical Hospital
Mogilev, Belarus
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
Cuiabá, 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
Hospital Paraná
Maringá, Brazil
Irmandade da Santa Casa de Misericórdia de Marília
Marília, Brazil
Hospital Procordis
Niterói, Brazil
Hospital Vera Cruz Patos de Minas
Patos de Minas, Brazil
Hospital Moinhos de Vento
Porto Alegre, Brazil
Hospital Mãe De Deus
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
São João do Paraíso, Brazil
Casa de Saude Santa Marcelina
São Paulo, Brazil
Hospital Albert Einstein
São Paulo, Brazil
Hospital Bandeirantes
São 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)
São Vicente, Brazil
Hospital Anchieta Ltda.
Taguatinga, Brazil
Instituto do Coração do Triângulo Mineiro
Uberlândia, Brazil
Insituto de Cardiologia Espirito Santo
Vitória, Brazil
Tokuda Hospital Sofia
Sofia, Bulgaria
Hospital Militar de Santiago
La Reina, Chile
clinica Santa Maria
Santiago, Chile
Instituto Nacional del Torax
Santiago, Chile
San Juan de Dios
Santiago, Chile
Las Higueras De Talcahuano
Talcahuano, Chile
V Region (Hospital Gustavo Fricke, Hospital Van Buren, Clinica Reñaca)
Valparaíso, Chile
Clinica alemana de Santiago
Vitacura, Chile
St. Anne University Hospital
Brno, Czechia
Nemocnice Na Homolce
Prague, 15030, Czechia
Gentofte Hospital (M12FU)
Hellerup, Denmark
Glory cardiac center - Cath group
Al Mansurah, 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
Al Noor Cath Lab
Sohag, Egypt
Om El kora cardiac center
Tanta, Egypt
East Tallinn Central Hospital
Tallinn, Estonia
North-Estonia Regional Hospital
Tallinn, Estonia
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, 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
Évecquemont, 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, 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
Hopital Lariboisière
Paris, France
Hopital Pitié Salpétrière
Paris, France
Hôpital du Val de Grâce
Paris, France
Hôpital Europeen Georges Pompidou (HEGP)
Paris, France
CH Pau
Pau, France
CH Général Maréchal Joffre Perpignan
Perpignan, France
Clinique Saint-Martin Pessac
Pessac, France
CH Périgueux
Périgueux, France
CHU La Miletrie Poitiers
Poitiers, France
CH René Dubos
Pontoise, France
Hopital Claude Galien
Quincy, France
Clinique Saint Laurent
Rennes, France
Hôpital Jacques Puel (CH de Rodez)
Rodez, France
Clinique Saint Hilaire
Rouen, France
Centre Cardiologique du Nord
Saint-Denis, France
NHC Strasbourg
Strasbourg, France
Clinique de l'Ormeau - CCV des Pyrenées
Tarbes, France
Polyclinique du Parc Toulouse
Toulouse, France
CH Valence
Valence, France
Clinique Vauban
Valenciennes, France
CH Bretagne Atlantique
Vannes, France
JoAnn Medical Center
Tbilisi, Georgia
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, Germany
Gottsegen National Cardiology Institute (GOKI)
Budapest, Hungary
Semmelweis University Cardiology Centre
Budapest, Hungary
Fejér Megyei Szent György Kórház
Székesfehérvár, Hungary
Medistra Hospital
Jakarta, Indonesia
National Cardiovascular Center Harapan Kita
Jakarta, Indonesia
Dr. Soetomo General Hospital, Surabaya
Surabaya, Indonesia
Beaumont Hospital
Dublin, Ireland
University Hospital Galway
Galway, Ireland
Rambam Medical centre
Haifa, Israel
Wolfson Medical Center
Holon, 58100, Israel
Meir Medical Center, Kfar-Saba
Kfar Saba, Israel
Laniado Medical Center
Netanya, Israel
Rabin Medical Center
Petah Tikva, Israel
Kaplan Hospital
Rehovot, Israel
Invasive Cardiology Laboratory of Clinics "Gailezers" of Riga's Eastern Clinical University Hospital
Riga, Latvia
Invasive Cardiology Laboratory of P. Stradins Clinical University Hospital
Riga, Latvia
Hospital of Lithuania University of Health Science
Kaunas, Lithuania
Mater Dei
Msida, Malta
Hospital Angeles Culiacan
Culiacán, Mexico
Hospital Angeles Leon
León, Guanajuato, Mexico
Hospital Star Medica Mérida Yucatán
Merida, Yucatan, Mexico
1e de Octubre ISSSTE
Mexico City, Mexico
Centro Médico Nacional 20 de Noviembre
Mexico City, Mexico
Hospital Angeles Mocel
Mexico City, Mexico
Hospital Central Militar
Mexico City, Mexico
Hospital de Cardiologia C.M.N.
Mexico City, Mexico
Instituto Nacional De Cardiologia "Ignacio Chávez"
Mexico City, 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, Mexico
Amphia Hospital
Breda, Netherlands
Albert Schweitzer Hospital
Dordrecht, Netherlands
Jeroen Bosch Ziekenhuis
s'Hertogenbosch, Netherlands
Medisch Centrum Haaglanden
The Hague, Netherlands
St Adalbert Speciality Hospital
Gdansk, Poland
Szpital Klinicznk Przemienienia (University Hospital)
Poznan, Poland
Szpital Wojewodzski Poznaniu
Poznan, Poland
Cardiolife Hospital Timisoara
Timișoara, 300014, Romania
Chelyabinsk Regional Clinical Hospital
Chelyabinsk, Russia
Military Hospital N3 named by Vishnevsky
Krasnogorsk, Russia
State cardiovascular center based on regional clin
Krasnoyarsk, Russia
Regional Clinical Hospital
Kursk, Russia
Central Clinical Hospital N°2 Russia Railways
Moscow, Russia
Academian E.N Meshalkin State Research Institute of circulation Pathology
Novosibirsk, 630055, Russia
Federal cardiosurgerical center, Penza
Penza, Russia
Kirochnaya str.41
Saint Petersburg, 191015, Russia
Federal center of heart,blood and endocrinology diseases named by Almazov
Saint Petersburg, Russia
Saratov Research Institute of science for cardiology
Saratov, Russia
Regional Vessel Center
Ufa, Russia
Ufa city Emergency Hospital
Ufa, Russia
Institute for Cardiovascular Disease Dedinje
Dedinje, Serbia
Clinical Center Kragujevac
Kragujevac, Serbia
Clinical Center of Niš
Niš, Serbia
CH Celje
Celje, Slovenia
Hospital Juan Canalejo
A Coruña, Spain
Hospital San Rafael
A Coruña, Spain
Hospital general de Albacete
Albacete, Spain
Hospital San Juan
Alicante, Spain
Hospital Torrecárdenas
Almería, 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 Nostra Señora Rossell
Cartagena, Spain
Hospital General de Castellón
Castellon, Spain
Hospital San Pedro de Alcantara-Caceres
Cáceres, Spain
Hospital Nostra Señora Alarcos
Ciudad Real, Spain
Hospital Cabueñes
Gijón, Spain
Hospital Universitario de Guadalajara
Guadalajara, 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 Candelaria
Santa Cruz de Tenerife, Spain
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, Spain
Hospital Virgen Salud
Toledo, Spain
Clínico Universitario Valencia
Valencia, Spain
Hospital Manises
Valencia, Spain
Hospital Meixoeiro-MEDTEC
Vigo, Spain
Hospital Txagorritxu
Vitoria-Gasteiz, Spain
Hospital Miguel Servet
Zaragoza, Spain
Falun Lasarett
Falun, Sweden
University Hospital Linköping
Linköping, Sweden
Uppsala Akademiska Sjukhus, Kardiologkliniken
Uppsala, Sweden
Central Lasarettet i Västerås, Angio/PCI lab. Medi
Västerås, Sweden
E-da Hospital/Kaohsiung
Kaohsiung City, Taiwan
Taichung Veterans General Hospital
Taichung R.o.c., Taiwan
Chi Mei Medical Center/Tainan
Tainan, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Cheng Hsin General Hospital / Taipei
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital, VACRS
Taipei, Taiwan
Kharkov Regional Hospital
Kharkiv, Ukraine
Feofaniya
Kiev, Ukraine
Ukrainian Institute of Cardiology
Kiev, Ukraine
National Institute of Cardiovascular Surgery AMS
Kyiv, Ukraine
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, United Kingdom
Related Publications (52)
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.
PMID: 2950322BACKGROUNDDetre 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.
PMID: 2394000BACKGROUNDHolmes 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.
PMID: 2971699BACKGROUNDFischman 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.
PMID: 8041414BACKGROUNDSerruys 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.
PMID: 8041413BACKGROUNDMorice 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.
PMID: 12050336BACKGROUNDStettler 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.
PMID: 17869634BACKGROUNDMoses 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.
PMID: 14523139BACKGROUNDHolmes 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.
PMID: 14769686BACKGROUNDGrube 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.
PMID: 12515740BACKGROUNDChevalier 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.
PMID: 19755281BACKGROUNDOstojic 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.
PMID: 19608483BACKGROUNDIakovou 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.
PMID: 15870416BACKGROUNDChevalier 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.
PMID: 20031715BACKGROUNDJain 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.
PMID: 17950836BACKGROUNDUrban P, Gershlick AH, Guagliumi G, Guyon P, Lotan C, Schofer J, Seth A, Sousa JE, Wijns W, Berge C, Deme M, Stoll HP; e-Cypher Investigators. Safety of coronary sirolimus-eluting stents in daily clinical practice: one-year follow-up of the e-Cypher registry. Circulation. 2006 Mar 21;113(11):1434-41. doi: 10.1161/CIRCULATIONAHA.104.532242. Epub 2006 Mar 13.
PMID: 16534015BACKGROUNDStone GW. SPIRIT IV A Prospective, Randomized Trial Comparing an Everolimus Eluting Stent and a Paclitaxel Eluting Stent in Patients With Coronary Artery Disease One Year Clinical Results. 2009.
BACKGROUNDGrube E, Spirit V registry: one-year follow-up. EuroIntervention 2009; 5
BACKGROUNDTurco MA, Ormiston JA, Popma JJ, Mandinov L, O'Shaughnessy CD, Mann T, McGarry TF, Wu CJ, Chan C, Webster MW, Hall JJ, Mishkel GJ, Cannon LA, Baim DS, Koglin J. Polymer-based, paclitaxel-eluting TAXUS Liberte stent in de novo lesions: the pivotal TAXUS ATLAS trial. J Am Coll Cardiol. 2007 Apr 24;49(16):1676-83. doi: 10.1016/j.jacc.2007.01.069. Epub 2007 Apr 6.
PMID: 17448368BACKGROUNDRodriguez-Granillo GA, Valgimigli M, Garcia-Garcia HM, Ong AT, Aoki J, van Mieghem CA, Tsuchida K, Sianos G, McFadden E, van der Giessen WJ, van Domburg R, de Feyter P, Serruys PW. One-year clinical outcome after coronary stenting of very small vessels using 2.25 mm sirolimus- and paclitaxel-eluting stents: a comparison between the RESEARCH and T-SEARCH registries. J Invasive Cardiol. 2005 Aug;17(8):409-12.
PMID: 16079445BACKGROUNDOng AT, van Domburg RT, Aoki J, Sonnenschein K, Lemos PA, Serruys PW. Sirolimus-eluting stents remain superior to bare-metal stents at two years: medium-term results from the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry. J Am Coll Cardiol. 2006 Apr 4;47(7):1356-60. doi: 10.1016/j.jacc.2005.05.102. Epub 2006 Mar 20.
PMID: 16580521BACKGROUNDGalloe AM, Thuesen L, Kelbaek H, Thayssen P, Rasmussen K, Hansen PR, Bligaard N, Saunamaki K, Junker A, Aaroe J, Abildgaard U, Ravkilde J, Engstrom T, Jensen JS, Andersen HR, Botker HE, Galatius S, Kristensen SD, Madsen JK, Krusell LR, Abildstrom SZ, Stephansen GB, Lassen JF; SORT OUT II Investigators. Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial. JAMA. 2008 Jan 30;299(4):409-16. doi: 10.1001/jama.299.4.409.
PMID: 18230778BACKGROUNDKedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet. 2010 Jan 16;375(9710):201-9. doi: 10.1016/S0140-6736(09)62127-9. Epub 2010 Jan 7.
PMID: 20060578BACKGROUNDNovack V, Cutlip D, Kleiman N, Pencina M, Mauri L, Yen CH, Berger P, Goldberg S, Kellett M, Waksman R, Hong M, Raizner AE, Cohen DJ. In-hospital and 1-year outcomes among unselected percutaneous coronary intervention patients treated with either sirolimus- or paclitaxel-eluting stents: results from the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) registry. JACC Cardiovasc Interv. 2009 Aug;2(8):767-75. doi: 10.1016/j.jcin.2009.05.016.
PMID: 19695546BACKGROUNDWindecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Davies S, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Juni P. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet. 2008 Sep 27;372(9644):1163-73. doi: 10.1016/S0140-6736(08)61244-1. Epub 2008 Aug 31.
PMID: 18765162BACKGROUNDSilber S, Albertsson P, Aviles FF, Camici PG, Colombo A, Hamm C, Jorgensen E, Marco J, Nordrehaug JE, Ruzyllo W, Urban P, Stone GW, Wijns W; Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J. 2005 Apr;26(8):804-47. doi: 10.1093/eurheartj/ehi138. Epub 2005 Mar 15.
PMID: 15769784BACKGROUNDShaw LJ, Berman DS, Maron DJ, Mancini GB, Hayes SW, Hartigan PM, Weintraub WS, O'Rourke RA, Dada M, Spertus JA, Chaitman BR, Friedman J, Slomka P, Heller GV, Germano G, Gosselin G, Berger P, Kostuk WJ, Schwartz RG, Knudtson M, Veledar E, Bates ER, McCallister B, Teo KK, Boden WE; COURAGE Investigators. Optimal medical therapy with or without percutaneous coronary intervention to reduce ischemic burden: results from the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial nuclear substudy. Circulation. 2008 Mar 11;117(10):1283-91. doi: 10.1161/CIRCULATIONAHA.107.743963. Epub 2008 Feb 11.
PMID: 18268144BACKGROUNDSafian R.D. and Freed M., Complications. In: The Manual of Interventional Cardiology Jones & Bartlett Publishers, 2001. 381-467
BACKGROUNDTillmanns H, Waas W, Voss R, Grempels E, Holschermann H, Haberbosch W, Waldecker B. Gender differences in the outcome of cardiac interventions. Herz. 2005 Aug;30(5):375-89. doi: 10.1007/s00059-005-2716-3. English, German.
PMID: 16132240BACKGROUNDBerger JS, Elliott L, Gallup D, Roe M, Granger CB, Armstrong PW, Simes RJ, White HD, Van de Werf F, Topol EJ, Hochman JS, Newby LK, Harrington RA, Califf RM, Becker RC, Douglas PS. Sex differences in mortality following acute coronary syndromes. JAMA. 2009 Aug 26;302(8):874-82. doi: 10.1001/jama.2009.1227.
PMID: 19706861BACKGROUNDBriguori C, Airoldi F, Chieffo A, Carlino M, Montorfano M, Colombo A. Renal function and drug-eluting stent. Int J Cardiol. 2010 Jun 25;142(1):92-4. doi: 10.1016/j.ijcard.2008.11.138. Epub 2009 Jan 15.
PMID: 19147241BACKGROUNDLatif F, Kleiman NS, Cohen DJ, Pencina MJ, Yen CH, Cutlip DE, Moliterno DJ, Nassif D, Lopez JJ, Saucedo JF; EVENT Investigators. In-hospital and 1-year outcomes among percutaneous coronary intervention patients with chronic kidney disease in the era of drug-eluting stents: a report from the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) registry. JACC Cardiovasc Interv. 2009 Jan;2(1):37-45. doi: 10.1016/j.jcin.2008.06.012.
PMID: 19463396BACKGROUNDRosenblum MA, Robbins MJ, Farkouh ME, Winston JA, Kim MC. Diminished benefits of drug-eluting stents versus bare metal stents in patients with severe renal insufficiency. Nephron Clin Pract. 2009;113(3):c198-202. doi: 10.1159/000232602. Epub 2009 Aug 12.
PMID: 19672119BACKGROUNDMehilli J, Dibra A, Kastrati A, Pache J, Dirschinger J, Schomig A; Intracoronary Drug-Eluting Stenting to Abrogate Restenosis in Small Arteries (ISAR-SMART 3) Study Investigators. Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels. Eur Heart J. 2006 Feb;27(3):260-6. doi: 10.1093/eurheartj/ehi721. Epub 2006 Jan 9.
PMID: 16401670BACKGROUNDPark SW, Lee CW, Hong MK, Kim JJ, Cho GY, Nah DY, Park SJ. Randomized comparison of coronary stenting with optimal balloon angioplasty for treatment of lesions in small coronary arteries. Eur Heart J. 2000 Nov;21(21):1785-9. doi: 10.1053/euhj.1999.1947.
PMID: 11052843BACKGROUNDOrtolani P, Marzocchi A, Marrozzini C, Palmerini T, Saia F, Taglieri N, Aquilina M, Baldazzi F, Silenzi S, Cooke RM, Reggiani ML, Branzi A. Randomized comparative trial of a thin-strut bare metal cobalt-chromium stent versus a sirolimus-eluting stent for coronary revascularization. Catheter Cardiovasc Interv. 2007 May 1;69(6):790-8. doi: 10.1002/ccd.21011.
PMID: 17290437BACKGROUNDTanimoto S, Daemen J, Serruys PW. Update on stents: recent studies on the TAXUS stent system in small vessels. Vasc Health Risk Manag. 2007;3(4):481-90.
PMID: 17969378BACKGROUNDElezi S, Kastrati A, Pache J, Wehinger A, Hadamitzky M, Dirschinger J, Neumann FJ, Schomig A. Diabetes mellitus and the clinical and angiographic outcome after coronary stent placement. J Am Coll Cardiol. 1998 Dec;32(7):1866-73. doi: 10.1016/s0735-1097(98)00467-7.
PMID: 9857865BACKGROUNDStettler C, Allemann S, Egger M, Windecker S, Meier B, Diem P. Efficacy of drug eluting stents in patients with and without diabetes mellitus: indirect comparison of controlled trials. Heart. 2006 May;92(5):650-7. doi: 10.1136/hrt.2005.070698. Epub 2005 Oct 26.
PMID: 16251229BACKGROUNDBoccara F, Teiger E, Cohen A. Role of drug eluting stents in diabetic patients. Heart. 2006 May;92(5):579-81. doi: 10.1136/hrt.2005.082172. Epub 2006 Jan 31.
PMID: 16449508BACKGROUNDSukhija R, Mehta JL, Sachdeva R. Present status of coronary bifurcation stenting. Clin Cardiol. 2008 Feb;31(2):63-6. doi: 10.1002/clc.20177.
PMID: 17763364BACKGROUNDKim YH, Park SW, Lee SW, Park DW, Yun SC, Lee CW, Hong MK, Kim HS, Ko JK, Park JH, Lee JH, Choi SW, Seong IW, Cho YH, Lee NH, Kim JH, Chun KJ, Park SJ; Long-DES-II Study Investigators. Sirolimus-eluting stent versus paclitaxel-eluting stent for patients with long coronary artery disease. Circulation. 2006 Nov 14;114(20):2148-53. doi: 10.1161/CIRCULATIONAHA.106.666396. Epub 2006 Oct 23.
PMID: 17060388BACKGROUNDHannan EL, Wu C, Walford G, Culliford AT, Gold JP, Smith CR, Higgins RS, Carlson RE, Jones RH. Drug-eluting stents vs. coronary-artery bypass grafting in multivessel coronary disease. N Engl J Med. 2008 Jan 24;358(4):331-41. doi: 10.1056/NEJMoa071804.
PMID: 18216353BACKGROUNDNakamura S, Nakamura S, Ogawa H, Bae JH, HansCahyadi Y, Udayachalerm W, DTresukosol D, Tansuphaswadikul S, Drug-eluting stents for the treatment of left main coronary artery disease with sirolimus, paclitaxel, zotarolimus, BiolimusA9, EPC capture and everolimus-eluting stent: multicenter registry in Asia (Oral Contributions Georgia World Congress Center, Room B315 Monday, March 15, 2010, 2:00 p.m.-2:12 p.m.). J Am Coll Cardiol 2010;55
BACKGROUNDLotan C, Almagor Y, Kuiper K, Suttorp MJ, Wijns W. Sirolimus-eluting stent in chronic total occlusion: the SICTO study. J Interv Cardiol. 2006 Aug;19(4):307-12. doi: 10.1111/j.1540-8183.2006.00151.x.
PMID: 16881976BACKGROUNDRahel BM, Suttorp MJ, Laarman GJ, Kiemeneij F, Bal ET, Rensing BJ, Ernst SM, ten Berg JM, Kelder JC, Plokker HW. Primary stenting of occluded native coronary arteries: final results of the Primary Stenting of Occluded Native Coronary Arteries (PRISON) study. Am Heart J. 2004 May;147(5):e22. doi: 10.1016/j.ahj.2003.11.023.
PMID: 15131557BACKGROUNDSuttorp MJ, Laarman GJ, Rahel BM, Kelder JC, Bosschaert MA, Kiemeneij F, Ten Berg JM, Bal ET, Rensing BJ, Eefting FD, Mast EG. Primary Stenting of Totally Occluded Native Coronary Arteries II (PRISON II): a randomized comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of total coronary occlusions. Circulation. 2006 Aug 29;114(9):921-8. doi: 10.1161/CIRCULATIONAHA.106.613588. Epub 2006 Aug 14.
PMID: 16908768BACKGROUNDNakamura S, Nakamura S, Ogawa H, Bae JH, HansCahyadi Y, Udayachalerm W, DTresukosol D, Tansuphaswadikul S, Drug-eluting stents for the treatment of chronic total occlusion: a comparison with sirolimus, paclitaxel, zotarolimus, BiolimusA9, EPC capture and everolimus-eluting stent: multicenter registry in Asia (Poster Contributions Georgia World Congress Center, Hall B5 Monday, March 15, 2010, 9:30 a.m.-10:30 a.m. ). J Am Coll Cardiol 2010;55.
BACKGROUNDHamm CW, Braunwald E. A classification of unstable angina revisited. Circulation. 2000 Jul 4;102(1):118-22. doi: 10.1161/01.cir.102.1.118.
PMID: 10880424BACKGROUNDBraunwald E. Unstable angina. A classification. Circulation. 1989 Aug;80(2):410-4. doi: 10.1161/01.cir.80.2.410. No abstract available.
PMID: 2752565BACKGROUNDCutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. doi: 10.1161/CIRCULATIONAHA.106.685313.
PMID: 17470709BACKGROUNDTIMI Study Group. The Thrombolysis in Myocardial Infarction (TIMI) trial. Phase I findings. N Engl J Med. 1985 Apr 4;312(14):932-6. doi: 10.1056/NEJM198504043121437. No abstract available.
PMID: 4038784BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dragica Paunovic, Dr.
Terumo Europe
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2010
First Posted
December 16, 2010
Study Start
August 25, 2010
Primary Completion
May 1, 2016
Study Completion
May 27, 2016
Last Updated
October 9, 2019
Record last verified: 2019-10