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e-NOBORI Observational Registry of Nobori DES

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Terumo Europe N.V.
Sponsor:
Information provided by (Responsible Party):
Terumo Europe N.V.
ClinicalTrials.gov Identifier:
NCT01261273
First received: December 14, 2010
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

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


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective, Single-Arm, Multi-Centre, Observational Registry to Further Validate Safety and Efficacy of the Nobori DES in Real-World Patients

Resource links provided by NLM:


Further study details as provided by Terumo Europe N.V.:

Primary Outcome Measures:
  • FREEDOM OF TARGET LESION FAILURE [ Time Frame: 1 YEAR ] [ Designated as safety issue: Yes ]
    TLF: COMPOSITE OF CARDIAC DEATH, MYOCARDIAL INFARCTION AND TARGET LESION REVASCULARIZATION


Secondary Outcome Measures:
  • Procedural success [ Time Frame: 1 MONTH ] [ Designated as safety issue: No ]
  • Device success [ Time Frame: 1 MONTH ] [ Designated as safety issue: No ]
  • Acute/subacute stent thrombosis [ Time Frame: 1 MONTH ] [ Designated as safety issue: Yes ]
    (definite/probable according to ARC definitions)

  • Peri-procedural myocardial infarction [ Time Frame: 1 MONTH ] [ Designated as safety issue: Yes ]
  • Rate of Major Adverse Cardiac Events (MACE) [ Time Frame: 1 MONTH ] [ Designated as safety issue: Yes ]
    Major Adverse Cardiac Events (MACE) defined as a composite of cardiac death, MI or clinically driven target vessel revascularization (TVR)

  • Major vascular and bleeding complications [ Time Frame: 1 MONTH ] [ Designated as safety issue: No ]
    NOT CABG RELATED

  • Cardiac death/ Myocardial Infarction [ Time Frame: 1 AND 2 YEARS ] [ Designated as safety issue: Yes ]
  • Clinically driven target lesion revascularization (TLR) [ Time Frame: 1 & 2 YEARS ] [ Designated as safety issue: Yes ]
    re-PCI or CABG involving target lesion

  • Stent thrombosis [ Time Frame: 1 AND 2 YEARS ] [ Designated as safety issue: Yes ]
    (definite/probable; ARC definition)

  • Clinically driven target vessel revascularization (TVR) [ Time Frame: 1 AND 2 YEARS ] [ Designated as safety issue: Yes ]
    PCI AND CABG

  • Target Lesion Failure (TLF) [ Time Frame: 1 MONTH AND 2 YEARS ] [ Designated as safety issue: Yes ]
    Defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization

  • 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 ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Cardiac death and MI [ Time Frame: 1 MONTH, 1 AND 2 YEARS ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Cardiac death and post-procedural MI [ Time Frame: 1 month, 1 and 2 years post-procedure ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 1 month, 1 and 2 years post-procedure ] [ Designated as safety issue: Yes ]
    definite and probable according to ARC definitions

  • Primary Stent thrombosis [ Time Frame: 1 month, 1 and 2 years post-procedure ] [ Designated as safety issue: Yes ]
    definite and probable according to ARC definitions

  • Secondary Stent thrombosis [ Time Frame: 1 month, 1 and 2 years post-procedure ] [ Designated as safety issue: Yes ]
    definite and probable according to ARC definitions

  • Duration of dual antiplatelet therapy [ Time Frame: UP TO 2 YEARS ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Clinically driven Target Lesion Revascularization [ Time Frame: 1 MONTH ] [ Designated as safety issue: Yes ]
  • Clinically driven Target Vessel Revascularization [ Time Frame: 1 MONTH ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18000
Study Start Date: August 2010
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients suitable for PCI intervention

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261273

Contacts
Contact: Dragica Paunovic, Dr dragica.paunovic@terumo-europe.com

  Hide Study Locations
Locations
Austria
SMZ-Donauspital Vienna Active, not recruiting
Vienna, Austria
Bangladesh
National Heart Foundation Hospital & Research Institute Recruiting
Dhaka, Bangladesh
Contact: Malik, Prof.         
Principal Investigator: Malik, Prof.         
Belarus
Republican Clinical Medical Center (Presidential Hospital) Active, not recruiting
Minsk, Belarus
Republican Scientific and Practical Center of Cardiology Active, not recruiting
Minsk, Belarus
Mogilev Regional Clinical Hospital Active, not recruiting
Mogilev, Belarus
Brazil
Hospital Madre Teresa Completed
Belo Horizonte-Minas Gerais, Brazil
Hospital Santa Isabel-Sociedade Divina Providência Completed
Blumenau, Brazil
Hospital Vera Cruz Campinas Active, not recruiting
Campinas, Brazil
HMCP PUC-Campinas Active, not recruiting
Campinas - SP, Brazil
Hospital E Maternidade Madre Teodora Completed
Campinas - SP, Brazil
Hospital Geral Universitário Active, not recruiting
Cuiaba, Brazil
Hospital Cruz Vermelha Brasileira Filial do Paraná Completed
Curitiba, Brazil
Hospital Nossa Senhora das Graças Active, not recruiting
Curitiba, Brazil
Hospital Santa Cruz Active, not recruiting
Curitiba, Brazil
Hospital Monte Sinai (Juiz de Fora) Active, not recruiting
Juiz de Fora, Brazil
Instituto Cardiovascular de Linhares (Unicor) Completed
Linhares, Brazil
Hospital do Coração de Londrina Active, not recruiting
Londrina, Brazil
Irmandade da Santa Casa de Misericórdia de Marília Completed
Marilia, Brazil
Hospital Paraná Active, not recruiting
Maringá, Brazil
Hospital Procordis Active, not recruiting
Niterói, Brazil
Hospital Vera Cruz Patos de Minas Active, not recruiting
Patos de Minas, Brazil
Hospital Moinhos de Vento Active, not recruiting
Porto Alegre, Brazil
Hospital Mãe De Deus Completed
Porto Alegre, Brazil
Hospital São Lucas - PUCRS Active, not recruiting
Porto Alegre, Brazil
Clinica Status Cor Active, not recruiting
Rio de Janeiro, Brazil
Hospital Naval Marcíllo Dias Completed
rio de Janeiro, Brazil
Fundação Bahiana de Cardiologia (MC Oliveira Prest Active, not recruiting
Salvador, Brazil
Hospital Beneficencia Portuguesa de Sao Paulo Completed
Sao Joao do Paraiso, Brazil
Hospital Bandeirantes Active, not recruiting
Sao Paulo, Brazil
Hospital Albert Einstein Completed
Sao Paulo, Brazil
Casa de Saude Santa Marcelina Completed
Sao Paulo, Brazil
Hospital Ana Costa (ENDOCOR Serviços Médicos Ltda) Active, not recruiting
Sao Vicente, Brazil
Instituto Dante Pazzanese Completed
São Paulo, Brazil
Real e Benemérita Assoção Portuguesa de Beneficênc Active, not recruiting
São Paulo, Brazil
Hospital Anchieta Ltda. Active, not recruiting
Taguatinga, Brazil
Instituto do Coração do Triângulo Mineiro Active, not recruiting
Uberlândia, Brazil
Insituto de Cardiologia Espirito Santo Active, not recruiting
Vitória, Brazil
Bulgaria
Tokuda Hospital Sofia Active, not recruiting
Sofia, Bulgaria
Chile
Hospital Militar de Santiago Active, not recruiting
La Reina, Chile
Instituto Nacional del Torax Active, not recruiting
Santiago, Chile
San Juan de Dios Active, not recruiting
Santiago, Chile
clinica Santa Maria Active, not recruiting
Santiago de Chile, Chile
Las Higueras De Talcahuano Active, not recruiting
Talcahuano, Chile
V Region (Hospital Gustavo Fricke, Hospital Van Buren, Clinica Reñaca) Active, not recruiting
Valparaíso, Chile
Clinica alemana de Santiago Active, not recruiting
Vitacura, Chile
Czech Republic
St. Anne University Hospital Active, not recruiting
Brno, Czech Republic
Nemocnice Na Homolce Active, not recruiting
Praha, Czech Republic, 15030
Denmark
Gentofte Hospital (M12FU) Active, not recruiting
Hellerup, Denmark
Egypt
International Cardiac Center Recruiting
Alexandria, Egypt
Contact: Mohamed Sobhy         
Principal Investigator: Mohamed Sobhy         
ALHYATT Cardiovascular Center Recruiting
Alexandria, Egypt
Contact: Hazem Namdouh Warda         
Principal Investigator: Hazem Namdouh Warda         
AL Amal Recruiting
Cairo, Egypt
Contact: Mohamed Ramdan, Dr         
Principal Investigator: Mohamed Ramdan, Dr         
Hayat Hospital Recruiting
Cairo, Egypt
Contact: Hany Ragy, Dr         
Principal Investigator: Hany Ragy, Dr         
AS-Salam Mohndseen Recruiting
Cairo, Egypt
Contact: Charles B Megally, Dr         
Principal Investigator: Charles B Megally, Dr         
Cleopatra Recruiting
Cairo, Egypt
Contact: Mohamed Awad Taher         
Principal Investigator: Mohamed Awad Taher         
Egyheart - cath lab Recruiting
Cairo, Egypt
Contact: Khaled Almeniawy, dr         
Principal Investigator: Khaled Almeniawy, dr         
El Dorah Heart Care Center Recruiting
Cairo, Egypt
Contact: Ahmed Khashaba, Dr         
Principal Investigator: Ahmed Khashaba, Dr         
Al Nakhil hospital Recruiting
Cairo, Egypt
Contact: Cr Yasser Sadek         
Principal Investigator: Cr Yasser Sadek         
Glory cardiac center - Cath group Recruiting
Dakahlia, Egypt
Contact: Raowf Mahran, Dr         
Principal Investigator: Raowf Mahran, Dr         
ICS center Recruiting
Egypt, Egypt
Contact: Islam Alaa Eldin, Dr.         
Principal Investigator: Islam Alaa Eldin, Dr.         
Om El kora cardiac center Active, not recruiting
Gharbia, Egypt
(DAFH) Dar Al Fouad Hospital Recruiting
Giza, Egypt
Contact: Nabil Farag, Dr.         
Principal Investigator: Nabil Farag, Dr.         
Alfa Recruiting
Giza, Egypt
Contact: Mohamed Ashraf, Dr         
Principal Investigator: Mohamed Ashraf, Dr         
RCC Cardiac center Recruiting
Giza, Egypt
Contact: Taher El-Kady         
Principal Investigator: Taher El-Kady         
Al Noor Cath Lab Recruiting
Sohag, Egypt
Contact: Moamen Lotly, dr         
Principal Investigator: Moamen Lotly, dr         
Estonia
East Tallinn Central Hospital Recruiting
Tallin, Estonia
Contact: Margus, Dr.         
Principal Investigator: Margus, Dr.         
North-Estonia Regional Hospital Recruiting
Tallin, Estonia
Contact: Jaanus Laanoja, Dr.         
Principal Investigator: Jaanus Laanoja, Dr.         
France
Clinique de l'Europe à Amiens (SAS Cardio Amiens) Active, not recruiting
Amiens, France
CHU Angers Active, not recruiting
Angers, France
Hôpital Privé d'Antony Active, not recruiting
Anthony, France
Hopital La Roseraie Active, not recruiting
Aubervilliers, France
CH Avignon Active, not recruiting
Avignon, France
Clinique Rhone Durance Active, not recruiting
Avignon, France
CH Bastia Active, not recruiting
Bastia Cedex, France
Clinique La Fourcade Active, not recruiting
Bayonne, France
Clinique Bois Bernard à Bois Bernard Active, not recruiting
Bois-Bernard, France
Clinique Saint Augustin Active, not recruiting
Bordeaux, France
CHU de la Cavale Blanche Active, not recruiting
Brest, France
CH Privé Saint - Martin Caen Active, not recruiting
Caen, France
CHU de la Cote de Nacre (CHU Caen) Active, not recruiting
Caen, France
Hopital Albert Schweitzer-Colmar Active, not recruiting
Colmar, France
CH Sud Francilien Active, not recruiting
Corbeil Essonnes, France
Clinique des Cèdres-Dr Brunelle Active, not recruiting
Cornebarrieu, France
Clinique des Cèdres-Dr.Tauzin Active, not recruiting
Cornebarrieu, France
Centre Cardiologique d'Evecquemont Active, not recruiting
Evecquemont, France
CH Haguenau Active, not recruiting
Hagueneau cedex, France
CH de Lagny-Marne La Vallée Active, not recruiting
Jossigny, France
CH de Cornouaille Active, not recruiting
La Cornuaille, France
CH La Roche sur Yon Active, not recruiting
La Roche sur Yon, France
CH de Chartres Active, not recruiting
Le Coudray, France
CC Marie Lannelongue Active, not recruiting
Le Plessis Robinson, France
Clinique La Louviere Active, not recruiting
Lille, France
CH Dupuytren Limoges Active, not recruiting
Limoges Cedex, France
CH Lorient Active, not recruiting
Lorient, France
Institut Hospitalier Jacques Cartier (ICPS Massy) Active, not recruiting
Massy, France
Clinique les Fontaines Active, not recruiting
Melun, France
Clinique du Millenaire Active, not recruiting
Montpellier, France
Hopital Pitié Salpétrière Active, not recruiting
Paris, France
Clinique Turin - Paris Active, not recruiting
Paris, France
Hopital Lariboisière Active, not recruiting
Paris, France
Association Clinique Bizet Active, not recruiting
Paris, France
Hôpital du Val de Grâce Active, not recruiting
Paris, France
Hôpital Europeen Georges Pompidou (HEGP) Active, not recruiting
Paris, France
CH Pau Active, not recruiting
Pau, France
CH Périgueux Active, not recruiting
Perigueux, France
CH Général Maréchal Joffre Perpignan Active, not recruiting
Perpignan, France
Clinique Saint-Martin Pessac Active, not recruiting
Pessac, France
CHU La Miletrie Poitiers Active, not recruiting
Poitiers, France
CH René Dubos Active, not recruiting
Pontoise, France
Hopital Claude Galien Active, not recruiting
Quincy, France
Clinique Saint Laurent Active, not recruiting
Rennes, France
Hôpital Jacques Puel (CH de Rodez) Active, not recruiting
Rodez, France
Clinique Saint Hilaire Active, not recruiting
Rouen, France
Centre Cardiologique du Nord Active, not recruiting
Saint Denis, France
NHC Strasbourg Active, not recruiting
Strasbourg, France
Clinique de l'Ormeau - CCV des Pyrenées Active, not recruiting
Tarbes, France
Polyclinique du Parc Toulouse Active, not recruiting
Toulouse, France
CH Valence Active, not recruiting
Valence, France
Clinique Vauban Active, not recruiting
Valenciennes, France
CH Bretagne Atlantique Active, not recruiting
Vannes, France
Georgia
JoAnn Medical Center Active, not recruiting
Tbilisi, Georgia
Germany
Zentralklinik Bad Berka GmbH Active, not recruiting
Bad Berka, Germany
Herz-und Diabeteszentrum Nordrhein-Westfalen Active, not recruiting
Bad Oeynhausen, Germany
Vivantes Netzwerk für Gesundheit gmbH - Humboldt Active, not recruiting
Berlin, Germany
Gemeinschaftskrankenhaus Havelhöhe Active, not recruiting
Berlin, Germany
Evangelisch Freikirchliches Krankenhaus und Herzze Active, not recruiting
Berlin, Germany
Klinikum Neukölln Active, not recruiting
Berlin, Germany
Vivantes Klinkum Spandau Active, not recruiting
Berlin, Germany
Vivantes Netzwerk für Gesundheit gmbH - Am Urban Active, not recruiting
Berlin, Germany
Vivantes Netzwerk für Gesundheit gmbH - Friedrichs Active, not recruiting
Berlin, Germany
Jüdisches Krankenhaus Active, not recruiting
Berlin, Germany
Ev.Bethesda-Johanniter Klinikum Duisburg GmbH Active, not recruiting
Duisburg, Germany
Klinikum Fulda Active, not recruiting
Fulda, Germany
Uniklinik Schleswig-Holstein, Campus Kiel Active, not recruiting
Kiel, Germany
Herzzentrum Leipzig-Rhöne Klinikum Active, not recruiting
Leipzig, Germany
St. Marienhospital Lünen Active, not recruiting
Lünen, Germany
Klinikum Oldenburg Active, not recruiting
Oldenburg, Germany
Universitätsklinik Rostock Active, not recruiting
Rostock, Germany
Evang.Diakonieanstalt Speyer Active, not recruiting
Speyer, Germany
Hungary
Gottsegen National Cardiology Institute (GOKI) Active, not recruiting
Budapest, Hungary
Semmelweis University Cardiology Centre Active, not recruiting
Budapest, Hungary
Fejér Megyei Szent György Kórház Active, not recruiting
Székesfehérvár, Hungary
Indonesia
Medistra Hospital Recruiting
Jakarta, Indonesia
Contact: Teguh Santoso, Prof.         
Principal Investigator: Teguh Santoso, Prof.         
National Cardiovascular Center Harapan Kita Active, not recruiting
Jakarta, Indonesia
Dr. Soetomo General Hospital, Surabaya Active, not recruiting
Surabaya, Indonesia
Ireland
Southern Health and Social Care Trust Craigavon Ar Active, not recruiting
Craigavon, Ireland
Beaumont Hospital Active, not recruiting
Dublin, Ireland
University Hospital Galway Active, not recruiting
Galway, Ireland
Israel
Rambam Medical centre Active, not recruiting
Haifa, Israel
Wolfson Medical Center Active, not recruiting
Holon, Israel, 58100
Meir Medical Center, Kfar-Saba Active, not recruiting
Kfar-Saba, Israel
Laniado Medical Center Active, not recruiting
Netanya, Israel
Rabin Medical Center Active, not recruiting
Petah Tikva, Israel
Kaplan Hospital Active, not recruiting
Rehovot, Israel
Latvia
Invasive Cardiology Laboratory of P. Stradins Clinical University Hospital Active, not recruiting
Riga, Latvia
Invasive Cardiology Laboratory of Clinics "Gailezers" of Riga's Eastern Clinical University Hospital Active, not recruiting
Riga, Latvia
Lithuania
Hospital of Lithuania University of Health Science Active, not recruiting
Kaunas, Lithuania
Malta
Mater Dei Active, not recruiting
Msida, Malta
Mexico
1e de Octubre ISSSTE Active, not recruiting
Ciudad de Mexico, Mexico
Hospital Angeles Culiacan Active, not recruiting
Culiacán, Mexico
Hospital Angeles Leon Active, not recruiting
León, Guanajuato, Mexico
Hospital Star Medica Mérida Yucatán Active, not recruiting
Merida, Yucatan, Mexico
Hospital Central Militar Active, not recruiting
Mexico City, Mexico
Instituto Nacional De Cardiologia "Ignacio Chávez" Active, not recruiting
Mexico DF, Mexico
Hospital de Cardiologia C.M.N. Active, not recruiting
Mexico DF, Mexico
Hospital Angeles Mocel Active, not recruiting
Mexico DF, Mexico
Centro Médico Nacional 20 de Noviembre Active, not recruiting
Mexico, D.F., Mexico
Hospital Universitario Dr. José Eleuterio Gonzalez Active, not recruiting
Monterrey, Nuevo León, Mexico
Dalinde Medical Center Active, not recruiting
México, DF, Mexico
Hospital Lomas de San Luis Internacional Active, not recruiting
San Luis Potosi SLP, Mexico
Netherlands
Amphia Hospital Recruiting
Breda, Netherlands
Contact: M. Meuwissen, Dr.         
Principal Investigator: M. Meuwissen, Dr.         
Medisch Centrum Haaglanden Active, not recruiting
Den Haag, Netherlands
Albert Schweitzer Hospital Recruiting
Dordrecht, Netherlands
Contact: Attila Dirkali, Dr.         
Principal Investigator: Attila Dirkali, Dr.         
Jeroen Bosch Ziekenhuis Recruiting
s'Hertogenbosch, Netherlands
Contact: Polad, Dr.         
Principal Investigator: Polad, Dr.         
Poland
St Adalbert Speciality Hospital Active, not recruiting
Gdansk, Poland
Szpital Wojewodzski Poznaniu Active, not recruiting
Poznan, Poland
Szpital Klinicznk Przemienienia (University Hospital) Active, not recruiting
Poznan, Poland
Romania
Cardiolife Hospital Timisoara Active, not recruiting
Timisoara, Romania, 300014
Russian Federation
Chelyabinsk Regional Clinical Hospital Active, not recruiting
Chelyabinsk, Russian Federation
Military Hospital N3 named by Vishnevsky Active, not recruiting
Krasnogorsk, Russian Federation
State cardiovascular center based on regional clin Recruiting
Krasnoyarsk, Russian Federation
Contact: Alexei Protopopov, Dr.         
Principal Investigator: Alexei Protopopov, Dr.         
Regional Clinical Hospital Active, not recruiting
Kursk, Russian Federation
Central Clinical Hospital N°2 Russia Railways Recruiting
Moscow, Russian Federation
Contact: Zaurbek Shugushev, Dr.         
Principal Investigator: Zaurbek Shugushev, Dr.         
Academian E.N Meshalkin State Research Institute of circulation Pathology Active, not recruiting
Novosibirsk, Russian Federation, 630055
Federal cardiosurgerical center, Penza Active, not recruiting
Penza, Russian Federation
Federal center of heart,blood and endocrinology diseases named by Almazov Recruiting
Saint-Petersburg, Russian Federation
Contact: Zverev Dimitriy, Dr.         
Principal Investigator: Zverev Dimitriy, Dr.         
Saratov Research Institute of science for cardiology Active, not recruiting
Saratov, Russian Federation
Kirochnaya str.41 Active, not recruiting
St-Petersburg, Russian Federation, 191015
Regional Vessel Center Recruiting
Ufa, Russian Federation
Contact: Sergei Vlasenco, Dr.         
Principal Investigator: Sergei Vlasenco, Dr.         
Ufa city Emergency Hospital Active, not recruiting
Ufa, Russian Federation
Serbia
Institute for Cardiovascular Disease Dedinje Active, not recruiting
Dedinje, Serbia
Clinical Center Kragujevac Active, not recruiting
Kragujevac, Serbia
Clinical Center of Niš Active, not recruiting
Niš, Serbia
Slovenia
CH Celje Active, not recruiting
Celje, Slovenia
Spain
Hospital general de Albacete Recruiting
Albacete, Spain
Contact: JESUS MARIA JIMENEZ MAZUECOS         
Principal Investigator: JESUS MARIA JIMENEZ MAZUECOS         
Hospital San Juan Recruiting
Alicante, Spain
Contact: Ramón López Palop, Dr.         
Principal Investigator: Ramón López Palop, Dr.         
Hospital Torrecárdenas Recruiting
Almeria, Spain
Contact: Rosa Lazaro, Dr.         
Principal Investigator: Rosa Lazaro, Dr.         
Hospital G. Trias i Pujol Recruiting
Badalona, Spain
Contact: Fina Mauri, Dr.         
Principal Investigator: Fina Mauri, Dr.         
Angiocor Withdrawn
Barcelona, Spain
Hospital Bellvitge Recruiting
Barcelona, Spain
Contact: Luis Miguel Teruel, Dr.         
Principal Investigator: Luis Miguel Teruel, Dr.         
Hospital Sant Pau Recruiting
Barcelona, Spain
Contact: Antoni Serra, Dr.         
Principal Investigator: Antoni Serra, Dr.         
Hospital de Cruces-Barakaldo Recruiting
Bilbao- Vizcaya, Spain
Contact: Juan Alcibar, Dr.         
Principal Investigator: Juan Alcibar, Dr.         
Hospital de Galdakao Recruiting
Bizkaia, Spain
Contact: Jose Ramón Rumoroso, Dr.         
Principal Investigator: Jose Ramón Rumoroso, Dr.         
Hospital San Pedro de Alcantara-Caceres Recruiting
Caceres, Spain
Contact: Javier Fernandez Portales, Dr.         
Principal Investigator: Javier Fernandez Portales, Dr.         
Hospital Nostra Señora Rossell Recruiting
Cartagena, Spain
Contact: Francisco Picó Aracil, Dr.         
Principal Investigator: Francisco Picó Aracil, Dr.         
Hospital General de Castellón Recruiting
Castellón, Spain
Contact: Pascual Baello, Dr.         
Principal Investigator: Pascual Baello, Dr.         
Hospital Nostra Señora Alarcos Recruiting
Ciudad Real, Spain
Contact: Vicente Fernandez Vallejo, Dr.         
Principal Investigator: Vicente Fernandez Vallejo, Dr.         
Hospital Cabueñes Recruiting
Gijón, Spain
Contact: Iñigo Lozano, Dr.         
Principal Investigator: Iñigo Lozano, Dr.         
Hospital Universitario de Guadalajara Recruiting
Guadalajara, Spain
Contact: Enrique Novo García, Dr.         
Principal Investigator: Enrique Novo García, Dr.         
Hospital Juan Canalejo Recruiting
La Coruña, Spain
Contact: Ramón Calviño Santos, Dr.         
Principal Investigator: Ramón Calviño Santos, Dr.         
Hospital San Rafael Recruiting
La Coruña, Spain
Contact: Gonzalo Peña, Dr.         
Principal Investigator: Gonzalo Peña, Dr.         
Clinica San Roque Recruiting
Las Palmas, Spain
Contact: Enrique Hernandez Ortega, Dr.         
Principal Investigator: Enrique Hernandez Ortega, Dr.         
Hospital de León Recruiting
León, Spain
Contact: Carlos Cuellas, Dr         
Principal Investigator: Carlos Cuellas, Dr.         
Clínica Moncloa Recruiting
Madrid, Spain
Contact: Eulogio García, Dr.         
Principal Investigator: Eulogio García, Dr.         
Hospital Fundacion Alcorcon Recruiting
Madrid, Spain
Contact: Javier Botas, Dr.         
Principal Investigator: Javier Botas, Dr.         
Hospital Puerta de Hierro Recruiting
Majadahonda-Madrid, Spain
Contact: Javier Goicolea, Dr.         
Principal Investigator: Javier Goicolea, Dr.         
Hospital Virgen Arrixaca Recruiting
Murcia, Spain
Contact: Mariano Valdés, Prof.         
Principal Investigator: Mariano Valdés, Prof.         
Universitario central de Asturias Recruiting
Oviedo, Spain
Contact: César Moris, Dr.         
Principal Investigator: César Moris, Dr.         
Hospital Clínico Universitario de Salamanca Recruiting
Salamanca, Spain
Contact: Ignacio Santos, Dr.         
Principal Investigator: Ignacio Santos, Dr.         
Hospital Clínico Universitario de Santiago de Compostela Recruiting
Santiago de Compostela, Spain
Contact: Ramiro Trillo Nouche, Dr.         
Principal Investigator: Ramiro Trillo Nouche, Dr.         
Hospital Candelaria Recruiting
Tenerife, Spain
Contact: Horacio Pérez, Dr.         
Principal Investigator: Horacio Pérez, Dr.         
Hospital Virgen Salud Recruiting
Toledo, Spain
Contact: José Moreu Burgos, Dr.         
Principal Investigator: José Moreu Burgos, Dr.         
Clínico Universitario Valencia Recruiting
Valencia, Spain
Contact: Luis Mainar, Dr.         
Principal Investigator: Luis Mainar, Dr.         
Hospital Manises Recruiting
Valencia, Spain
Contact: Luis Mainar, Dr.         
Principal Investigator: Luis Mainar, Dr.         
Hospital Meixoeiro-MEDTEC Recruiting
Vigo, Spain
Contact: Andrés Iñiguez Romo, Dr.         
Principal Investigator: Andrés Iñiguez Romo, Dr.         
Hospital Txagorritxu Recruiting
Vitoria, Spain
Contact: Alfonso Torres, Dr.         
Principal Investigator: Alfonso Torres, Dr.         
Hospital Miguel Servet Recruiting
Zaragoza, Spain
Contact: Isabel Calvo, Dra.         
Principal Investigator: Isabel Calvo, Dra.         
Sweden
Falun Lasarett Active, not recruiting
Falun, Sweden
University Hospital Linköping Active, not recruiting
Linköping, Sweden
Uppsala Akademiska Sjukhus, Kardiologkliniken Active, not recruiting
Uppsala, Sweden
Central Lasarettet i Västerås, Angio/PCI lab. Medi Active, not recruiting
Västerås, Sweden
Taiwan
E-da Hospital/Kaohsiung Completed
Kaohsiung, Taiwan
Taichung Veterans General Hospital Active, not recruiting
Taichung R.O.C., Taiwan
National Cheng Kung University Hospital Active, not recruiting
Tainan, Taiwan
Chi Mei Medical Center/Tainan Completed
Tainan, Taiwan
Cheng Hsin General Hospital / Taipei Completed
Taipei, Taiwan
Taipei Veterans General Hospital, VACRS Completed
Taipei, Taiwan
National Taiwan University Hospital Active, not recruiting
Taipei, Taiwan
Ukraine
Kharkov Regional Hospital Active, not recruiting
Kharkov, Ukraine
Feofaniya Active, not recruiting
Kiev, Ukraine
Ukrainian Institute of Cardiology Active, not recruiting
Kiev, Ukraine
National Institute of Cardiovascular Surgery AMS Active, not recruiting
Kyiv, Ukraine
United Kingdom
Queen Elizabeth Birmingham Active, not recruiting
Birmingham, United Kingdom
Royal Cornwall hospital Active, not recruiting
Cornwall, United Kingdom
Castle Hill Hospital Active, not recruiting
Cottingham, United Kingdom
Scunthorpe general hospital Active, not recruiting
District of North East Lincolnshire, United Kingdom
Dorset county Hospital Active, not recruiting
Dorset, United Kingdom
Eastbourne General Active, not recruiting
Eastbourne, United Kingdom
Glenfield general hospital Active, not recruiting
Glenfield, United Kingdom
Conquest Hospital Hastings Active, not recruiting
Hastings, United Kingdom
Royal Blackpool hospital (Lancashire Heart Centre) Active, not recruiting
Lancashire, United Kingdom
Northwick Park Active, not recruiting
London, United Kingdom
Freeman Hospital Active, not recruiting
Newcastle upon Tyne, United Kingdom
Royal Gwent Hospital Active, not recruiting
Newport, United Kingdom
Fairfield General Hospital Active, not recruiting
North Manchester, United Kingdom
Kettering General Hospital Active, not recruiting
Northamptonshire, United Kingdom
Frimley Park Hospital NHS Foundation Trust Active, not recruiting
Surrey, United Kingdom
Pinderfield General Hospital Active, not recruiting
Wakefield, United Kingdom
New Cross Wolverhampton Active, not recruiting
Wednesfield, United Kingdom
Sponsors and Collaborators
Terumo Europe N.V.
Investigators
Study Chair: Dragica Paunovic, Dr. Terumo Europe
  More Information

Publications:
Grube E, Spirit V registry: one-year follow-up. EuroIntervention 2009; 5
Safian R.D. and Freed M., Complications. In: The Manual of Interventional Cardiology Jones & Bartlett Publishers, 2001. 381-467
Nakamura 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
Nakamura 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.

Responsible Party: Terumo Europe N.V.
ClinicalTrials.gov Identifier: NCT01261273     History of Changes
Other Study ID Numbers: T113E2
Study First Received: December 14, 2010
Last Updated: July 18, 2014
Health Authority: Hungary: National Institute of Pharmacy
Belarus: Ministry of Health
Brazil: Ethics Committee
Chile: Comité de Ética Científico
Estonia: Research Ethics Committee
France: Institutional Ethical Committee
Germany: Ethics Commission
Indonesia: Ethics Committee
Ireland: Research Ethics Committee
Israel: Ethics Commission
Latvia: Institutional Review Board
Lithuania: Bioethics Committee
Malta: Medicines Authority
Netherlands: Independent Ethics Committee
Pakistan: Research Ethics Committee
Slovenia: Ethics Committee
Spain: Comité Ético de Investigación Clínica
Sweden: Regional Ethical Review Board
Taiwan: Research Ethics Committee

Keywords provided by Terumo Europe N.V.:
PCI
observational registry

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014