Prospective, Single-arm, Multi Centre Observations Ultimaster Des Registry (e-Ultimaster)

October 6, 2019 updated by: Terumo Europe N.V.

Prospective, Single Arm, Multi-centre, Observational Registry to Further Validate Safety and Efficacy of the Ultimaster Des System in Unselected Patients Representing Everyday Clinical Practice

The e-Ultimaster will further validate the safety and efficacy of Ultimaster DES system in unselected patients representing everyday clinical practice. Also the study will assess the impact of non-compliance with dual antiplatelet therapy, one month after stent implementation (frequently observed in every day clinical practice), on stent thrombosis.

Study Overview

Status

Unknown

Conditions

Detailed Description

All consecutive patients suitable for treatment with DES according to hospital routine practice in centres across the world that agree to participate in the e-ULTIMASTER registry will be treated with Ultimaster DES.

Secondary objectives Evaluation of worldwide utilization of DES, Detection of rare events in representative patient population, identification of predictors of major advers events, assessment of radial access site utilization and its impact on bleeding and vascular complications, assessment of procedural particularities and patients pathology in wide geographic area, assessment of duration and type of DAPT, assesment of the performace of Ultimaster DES is patients lesions subsets, assessment of possible benefits of biodegradable polymer in lager complex patiets/lesions subset and assessment of sirolimus efficacy in different races.

Data will be collected in a e-CRF and online monitoring will be done. Audits will be allowed by sponsor or qualified designees.

Study Type

Observational

Enrollment (Anticipated)

37000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina
        • Hospital Universitario Austral
      • Buenos Aires, Argentina
        • Fundacion Favaloro
      • Buenos Aires, Argentina
        • Hospital San Juan de Dios
      • CABA - Buenos Aires, Argentina
        • Instituto Cardiovascular de Buenos Aires
      • Junin, Argentina
        • Clinica Centro Médico Privado Junin
      • Monte Grande, Argentina
        • Clinica Monte Grande
      • Rosario, Argentina
        • Instituto Cardiovascular de Rosario
      • San Miguel, Argentina
        • Sanatorio San Miguel
      • Gyumri, Armenia, 3103
        • Medical center Gyumri CJSC
      • Yerevan, Armenia
        • "QANCOR" cardiovascular MC LLC
      • Yerevan, Armenia
        • Astghik Medical Center (Natali Farm)
      • Yerevan, Armenia
        • QANCOR Cardiovascular MC LLC
      • Yerevan, Armenia
        • Republican Medical Center Armenia CJSC
      • Yerevan, Armenia
        • Yerevan State medical University Hospital
      • Graz, Austria
        • Medizinische Universität Graz
      • Linz, Austria
        • AKH Linz
      • Vienna, Austria
        • Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
      • Vienna, Austria
        • Krankenanstalt Rudolfstiftung der Stadt Wien
      • Vienna, Austria
        • Vienna General Hospital
      • Dhakuli, Bangladesh
        • National Heart Foundation Hospital and Research Institute
      • Minsk, Belarus
        • City Clinical Emergency Hospital
      • Minsk, Belarus
        • RSPC
      • Aalst, Belgium
        • OLVZ Aalst
      • Aalst, Belgium
        • OLVZ Aalst, Onze Lieve Vrouw Ziekenhuis vzw-Campus Aalst
      • Bonheiden, Belgium
        • Imelda Ziekenhuis
      • Bonheiden, Belgium
        • Imelda Ziekenhuis - Bonheiden
      • Brussels, Belgium
        • Cliniques Saint-Luc
      • Charleroi, Belgium
        • CHU Charleroi
      • Gent, Belgium
        • Az Sint Lucas
      • Hornu, Belgium
        • Epicura-Hornu
      • Ieper, Belgium
        • JAN YPERMAN Ziekenhuis
      • Liège, Belgium
        • CHR de la Citadelle
      • Mons, Belgium
        • Hôpital Ambroise Paré de Mons
      • Yvoir, Belgium
        • CHU UCL Mont Godinne Namur
      • Belo Horizonte, Brazil
        • Hospital Felicio Rocho
      • Joinville, Brazil
        • Unimed Joinville
      • Juiz De Fora, Brazil
        • Hospital Monte Sinai
      • Linhares, Brazil
        • UNICOR
      • Maringá, Brazil
        • Parana Medical Research Center
      • Natal, Brazil
        • Eurolatino Natal Medical Research
      • Passo Fundo, Brazil
        • Hospital Sao Vicente de Paulo
      • Porto Alegre, Brazil
        • Hospital Moinhos de Vento
      • Santo André, Brazil
        • Hospital e Maternidade Dr. Christóvão da Gama
      • São Paulo, Brazil
        • Beneficencia Portuguesa de Sao Paulo
      • São Paulo, Brazil
        • Hospital Santa Cruz
      • Blagoevgrad, Bulgaria
        • "Mhat Puls" Ad
      • Burgas, Bulgaria
        • City Clinic Burgas
      • Haskovo, Bulgaria
        • MBAL Haskovo AD
      • Lovech, Bulgaria
        • Cardiolife-Lovech
      • Montana, Bulgaria
        • Mbal Montana City Clinic Sveti Georgi
      • Plovdiv, Bulgaria
        • MHAT Plovdiv
      • Plovdiv, Bulgaria
        • MBAL St. Karidad
      • Plovdiv, Bulgaria
        • University Hospital Sveti Georgi
      • Sofia, Bulgaria
        • Tokuda Hospital
      • Sofia, Bulgaria
        • National Heart Hospital
      • Sofia, Bulgaria
        • City clinic University Multi-Profile Hospital for Acute Care,Sofia
      • Sofia, Bulgaria
        • MBAZ-II-Sofia
      • Sofia, Bulgaria
        • MHATEM N.I.Pirogov
      • Sofia, Bulgaria
        • UMHAT Alexandrovska
      • Sofia, Bulgaria
        • UMHAT St.Ekaterina
      • Stara Zagora, Bulgaria
        • Trakiya Hospital
      • Stara Zagora, Bulgaria
        • Umbal Stojan Kirkovich
      • Varna, Bulgaria
        • Specialized Cardiology Hospital for Active Treatment
      • Vidin, Bulgaria
        • MBAL Sveta Petka Vidin
      • Antofagasta, Chile
        • Hospital Antofagasta
      • Concepcion, Chile
        • Hospital Guillermo Grant Benavente
      • Puerto Montt, Chile
        • Hospital Regional Puerto Montt
      • Region Metropolitana, Chile
        • Clínica Bicentenario
      • Santiago, Chile
        • Hospital San Juan de Dios
      • Santiago, Chile
        • Clinica Santa Maria
      • Santiago, Chile
        • Hospital San Borja Arriarán
      • Valparaíso, Chile
        • Hospital Van Buren
      • Bogota, Colombia
        • Clinica Marly
      • Bogota, Colombia
        • Clínica SHAIO
      • Bucaramanga, Colombia
        • Fundacion Cardiovascular de Colombia
      • Bucaramanga, Colombia
        • Instituto del Corazón de Bucaramanga
      • Manizales, Colombia
        • Centro Cardiovascular de Caldas
      • Brno, Czechia
        • Fakultni nemocnice u svate Anny v Brne
      • Karlovy Vary, Czechia
        • Karlovarska krajska nemocnice
      • Prague, Czechia
        • Kardiologie na Bulovce
      • Zlín, Czechia
        • Krajska nemocnice T. Bati
    • Srobarova
      • Prag, Srobarova, Czechia
        • FNKV
      • Alexandria, Egypt
        • Police Hospital
      • Cairo, Egypt
        • Al Hayat Hospital
      • Cairo, Egypt
        • Al Nakheel Hospital
      • Cairo, Egypt
        • Dr Ahmed Abdel Aziz Multicenter
      • Cairo, Egypt
        • Dr Hisham Ammar Multicenter
      • Cairo, Egypt
        • Dr Hussien Heshmat - As Salam International Hospital
      • Cairo, Egypt
        • Dr. Tarek Rashid
      • Cairo, Egypt
        • Dr.Hazem Al Guindi
      • Cairo, Egypt
        • El Marwa Hospital
      • Cairo, Egypt
        • Italian Hospital
      • Cairo, Egypt
        • Nile Badrawy Hospital
      • Cairo, Egypt
        • Sheraton Hospital for Medical Services
      • Cairo, Egypt
        • Wadi El Neel Hospital
      • El Gharbeya, Egypt
        • Um El Korra Hospital
      • Menofia, Egypt
        • L-Fouad Cardiac Center
      • Tallinn, Estonia
        • East-Tallinn Central Hospital
      • Tallinn, Estonia
        • North Estonia Medical Center
      • Angers, France
        • CHU Angers
      • Aubervilliers, France
        • Hopital Européen de Paris La Roseraie
      • Avignon, France
        • Clinique Rhône Durance
      • Bayonne, France
        • GCS Cardiologique de Bayonne
      • Bordeaux, France
        • Clinique St Augustin Bordeaux-Centre d'exploration-chirurgie
      • Caen, France
        • CHU Caen
      • Caen, France
        • Hôpital Prive Saint Martin
      • Clermont-Ferrand, France
        • CHU Clermont-Ferrand
      • Clermont-Ferrand, France
        • Pôle Santé République Clermont Ferrand
      • Colmar, France
        • Hopital Albert Schweitzer GHCA Colmar
      • Corbeil Essonnes, France
        • CH Sud Francilien
      • Dijon, France
        • Clinique de Fontaine
      • Grenoble, France
        • Groupement mutualiste de Grenoble
      • Haguenau, France
        • CH Haguenau
      • Jossigny, France
        • CH de Marne la Vallée
      • La Roche sur Yon, France
        • CHD Vendée La Roche sur Yon
      • La Rochelle, France
        • Groupe Hospitalier de la Rochelle Ré Aunis
      • Le Coudray, France
        • CH Louis Pasteur-Le Coudray
      • Lille, France
        • Hopital privé La Louviere-Lille
      • Lyon, France
        • CH St Joseph St Luc Lyon
      • Massy, France
        • Hopital Privé Jacques Cartier Massy
      • Montauban, France
        • Clinique du Pont de Chaume Montauban
      • Montpellier, France
        • Clinique du Milénaire
      • Montreuil, France
        • CH Montreuil
      • Mulhouse, France
        • Clinique Diaconat Fonderie Mulhouse
      • Nancy, France
        • Clinique Louis Pasteur Essey les Nancy
      • Nantes, France
        • Le Confluent Nouvelles Cliniques Nantaises
      • Neuilly Sur Seine, France
        • Clinique Ambroise Pare
      • Ollioules, France
        • Polyclinique Les Fleurs
      • Orléans, France
        • CHR ORLEANS
      • Paris, France
        • Groupe Hopitalier Paris Saint Joseph
      • Pau, France
        • Centre Hospitalier de Pau
      • Pessac, France
        • Hopital privé St Martin Pessac (DR Levy)
      • Pessac, France
        • Hôpital Privé St Martin de Pessac
      • Poitiers, France
        • CHU de Poitiers
      • Pontoise, France
        • Ch Rene Dubos Pontoise
      • Quimper, France
        • CHIC Quimper
      • Quincy sous sénart, France
        • Hopiatl Privé Claude Galien Quincy
      • Rennes, France
        • Clinique Saint-Laurent Rennes
      • Rouen, France
        • Clinique St Hilaire Rouen
      • Saint Brieuc, France
        • CH Yves le Foll - Saint Brieuc
      • Saint Pierre, France
        • CH La Timone Marseille
      • Saint-Quentin, France
        • CH Général de Saint Quentin
      • St Laurent du Var, France
        • Institut Arnault Tzanck St Laurent du Var
      • Strasbourg, France
        • Nouvel Hôpital Civil de Strasbourg
      • Trélazé, France
        • Clinique Saint Joseph
      • Valence, France
        • CH de Valence
      • Vannes, France
        • CH Bretagne Atlantique
      • Tbilisi, Georgia
        • Diagnostic Services Ltd. Cardio Clinic
      • Tbilisi, Georgia
        • Helsicore Clinic
      • Tbilisi, Georgia
        • JoAnn Medical Center
      • Budapest, Hungary
        • Semmelweis University
      • Gyula, Hungary
        • Hospital Pándy Kálmán
      • Kaposvár, Hungary
        • Moritz Kaposi General Hospital
      • Nyíregyháza, Hungary
        • Szatmar-Szabolcs-Bereg county hospital and university teaching hospital
      • Pecs, Hungary
        • Pécs University
      • Szombathely, Hungary
        • Markusovszky University Teaching Hospital
      • Reykjavik, Iceland
        • Landspitali National University Hospital
      • Aurangabad, India
        • Kamalnayan Bajaj Hospital
      • Chennai, India
        • MMM, Chennai
      • Coimbatore, India
        • G. Kuppuswamy Naidu Memorial Hospital (GKNM), Coimbatore
      • Delhi, India
        • Medanta Hospital, Delhi
      • Hyderabad, India
        • CARE Hospital, Hyderabad
      • Jaipur, India
        • SMS Hospital, Jaipur
      • Kolkata, India
        • BM Birla, Kolkata
      • Mangalore, India
        • KMC, Mangalore
      • Mohali, India
        • Fortis Hospital, Mohali
      • Mumbai, India
        • H.J. Doshi Ghatkopar Hindusabha Hospital
      • Mumbai, India
        • Hiranandani Hospital, Mumbai
      • Nagpur, India
        • Wockhardt Hospital, Nagpur
      • New Delhi, India
        • Maharaja Agrasen Hospital, New Delhi
      • New Delhi, India
        • Max Super Speciality Hospital, Saket, Delhi
      • Trivanderum, India
        • SCTIT, Trivanderum
      • Jakarta, Indonesia
        • Medistra Hospital
      • Jakarta Barat, Indonesia
        • National Cardiovascular Center Harapan Kita
      • Jakarta Pusat, Indonesia
        • RSUPN Cipto Mangunkusumo
      • Jakarta Selatan, Indonesia
        • RSUP Fatmawati General Hospital
      • Jakarta Timur, Indonesia
        • Binawaluya Cardiac Center
      • Makassar, Indonesia
        • Awal Bros Hospital
      • Makassar, Indonesia
        • Dr. Wahidin Sudirohusodo General Hospital
      • Malang, Indonesia
        • Saiful Anwar Hospital
      • Surabaya, Indonesia
        • Dr. Soetomo General Hospital
      • Cork, Ireland
        • Cork University Hospital
      • Galway, Ireland
        • University Hospital Galway
      • Limerick, Ireland
        • University Hospital Limerick
      • Haifa, Israel
        • Rambam Medical Center
      • Nahariya, Israel
        • Galilee Medical Center
      • Tzrifin, Israel
        • Assaf Harofeh Medical Center
      • Zefat, Israel
        • Ziv M.C
      • Amagasaki Hyougo, Japan
        • Kansai Rosai Hospital
      • Fukuoka, Japan
        • Kokura Memorial Hospital
      • Fukushima, Japan
        • Iwaki Kyoritsu General Hospital
      • Hachiōji, Japan
        • Tokai University Hachiouji Hospital
      • Hakodate Hokkaido, Japan
        • Hakodate Municipal Hospital
      • Hamamatsu, Japan
        • Seirei Hamamatsu General Hospital
      • Kakogawa, Japan
        • Kakogawa East City Hospital
      • Kanagawa, Japan
        • Shonan Kamakura General Hospital
      • Komaki Aichi, Japan
        • Komaki City Hospital
      • Kyoto, Japan
        • Kyoto Katsura Hospital
      • Maebashi, Japan
        • Gunma Prefectural Cardiovascular Center
      • Mie, Japan
        • Mie Heart Center
      • Osaka, Japan
        • Osaka General Medical Center
      • Osaka, Japan
        • Sakurabashi Watanabe Hospital
      • Saitama, Japan
        • Saitama Cardiovascular and Respiratory Center
      • Sakai, Japan
        • Mimihara General Hospital
      • Sakai Osaka, Japan
        • Osaka Rosai Hospital
      • Sapporo Hokkaido, Japan
        • Sapporo Higashi Tokushukai Hospital
      • Suita, Japan
        • Saiseikai Senri Hospital
      • Suntougun Shizuoka, Japan
        • Okamura memorial hospital
      • Takarazuka Hyougo, Japan
        • Higashi Takarazuka Satoh Hospital
      • Tennri Nara, Japan
        • Kouseikai Takai Hospital
      • Yamaguchi, Japan
        • Saiseikai Yamaguchi General Hospital
      • Yokohama, Japan
        • Saiseikai Yokohama City Eastern Hospital
      • Yokohama, Japan
        • Seirei Yokohama Hospital
      • Yokohama Kanagawa, Japan
        • Showa University Fujigaoka Hospital
      • Amman, Jordan
        • Jordan Hospital
      • Aktobe, Kazakhstan
        • Aktobe Regional Hospital
      • Aktobe, Kazakhstan
        • Medical University Clinic West Kazakhstan
      • Almaty, Kazakhstan
        • Almaty city cardio center
      • Almaty, Kazakhstan
        • National Surgery Center Almat
      • Astana, Kazakhstan
        • City Hospital #2
      • Astana, Kazakhstan
        • JSC Nat. Scient. Cardiosurgery Ctr.
      • Astana, Kazakhstan
        • National Scientific Medical Research Center JSC
      • Karaganda, Kazakhstan
        • Regional Cardiosurgery Center
      • Karagandy, Kazakhstan
        • Karagandy Regional Cardiac Center
      • Kokshetau, Kazakhstan
        • Akmola Regional Hospital
      • Pavlodar, Kazakhstan
        • Pavlodar Regional Cardiologic center
      • Petropavl, Kazakhstan
        • Cardiology Center Petropavl
      • Rudnyi, Kazakhstan
        • Rudnyi City Hospital
      • Semey, Kazakhstan
        • University Hospital of Semey
      • Shymkent, Kazakhstan
        • Shymkent Regional Cardiology Center
      • Taraz, Kazakhstan
        • Clinical Center of Cardiac Surgery and Transplantation
      • Kuwait, Kuwait
        • Sabah Al Ahmad Cardiac Center
      • Beirut, Lebanon
        • Hopital Abou Jaoudé
      • Sidon, Lebanon
        • Labib Medical Center
      • Kaunas, Lithuania
        • LSMU Kauno klinikos
      • Klaipėda, Lithuania
        • Klaipeda Seamen's Hospital
      • Alor Setar, Kedah, Malaysia
        • Hospital Sultanah Bahiyah
      • Kajang, Malaysia
        • Hospital Serdang
      • Kuala Lumpur, Malaysia
        • Desa Park City
      • Kuala Lumpur, Malaysia
        • HSC Medical Center
      • Kuantan, Malaysia
        • Hospital Tengku Ampuan Afzan
      • Sungai Buloh, Malaysia
        • UiTM Sg. Buloh Campus
      • Michoacan, Mexico
        • Fray Juan de San Miguel
      • Sonora, Mexico
        • Clinica Hospital San Jose de Navojoa SA de CV
      • Yucatán, Mexico
        • Hospital Star Médica Merida
      • Casablanca, Morocco
        • Clinique Achifaa de Casablanca
      • Marrakech, Morocco
        • CLINIQUE INTERNATIONALE de Marrakech
      • Marrakesh, Morocco
        • Clinique Grant Atlas
      • Rabat, Morocco
        • Cherradi_Clinique Agdal
      • Amersfoort, Netherlands
        • Meander Amersfoort
      • Arnhem, Netherlands
        • Rijnstate
      • Breda, Netherlands
        • Amphia Ziekenhuis
      • Den Bosch, Netherlands
        • Jeroen Bosch Ziekenhuis
      • Den Haag, Netherlands
        • Medisch Centrum Haaglanden
      • Dordrecht, Netherlands
        • Albert Schweitzer Ziekenhuis
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis
      • Eindhoven, Netherlands
        • Catharina Hospital
      • Emmen, Netherlands
        • Scheper Ziekenhuis
      • Enschede, Netherlands
        • Medisch Spectrum Twente
      • Leeuwarden, Netherlands
        • Medisch Centrum Leeuwarden
      • Rotterdam, Netherlands
        • Maasstad Ziekenhuis
      • Terneuzen, Netherlands
        • Zorgzaam Ziekenhuis Zeeuws-Vlaanderen
      • Venlo, Netherlands
        • Viecuri Medical Centre
      • Skopje, North Macedonia
        • City General Hospital 8th September Skopje
      • Skopje, North Macedonia
        • University Clinic of Cardiology
      • Muscat, Oman
        • Muscat Private Hospital
      • Lubin, Poland
        • Miedziowe Centrum Zdrowia
      • Poznan, Poland
        • Szpital Kliniczny Przemienienia Panskiego UM im. K. Marcinkowskiego w Poznaniu
      • Warsaw, Poland
        • Infant Jesus Teaching Hospital
      • Warsaw, Poland
        • Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego
      • Lisboa, Portugal
        • Hospital Santa Maria
      • Braşov, Romania
        • Clinicile ICCO
      • Constanţa, Romania
        • Centrele de Exelenta ARES
      • Sibiu, Romania
        • Spitalul Judetean de Urgenta Sibiu
      • Timisoara, Romania
        • Cordismed SRL
      • North Region Arar KSA, Saudi Arabia
        • Prince Abdullah Bin Abdulaziz Cardiac Center
      • Riyadh, Saudi Arabia
        • Dallah Hospital
      • Belgrade, Serbia
        • CHC Bezanijska Kosa
      • Belgrade, Serbia
        • Cardiology Clinic, Clinical Centre of Serbia
      • Belgrade, Serbia
        • Cardiovascular Institute Dedinje
      • Belgrade, Serbia
        • KBC Zvezdara
      • Kragujevac, Serbia
        • Clinical Center Kragujevac
      • Sremska Kamenica, Serbia
        • Institute of Cardiovascular Diseases Vojvodina
      • Banská Bystrica, Slovakia
        • Stredodlovensky Ustav Srdcovych A Cievnych Chorob
      • Centurion, South Africa
        • Dr JCW Badenhorst - Netcare Unitas Hospital
      • Centurion, South Africa
        • Unitas Hospital - Dr. Ebrahim
      • Centurion, South Africa
        • Unitas Hospital
      • Johannesburg, South Africa
        • Milpark Hospital
      • Johannesburg, South Africa
        • Netcare Union Hospital
      • Newlands, South Africa
        • Ethekwini Hospital & Heart Centre
      • Port Elizabeth, South Africa
        • Netcare Greenacres Hospital
      • Pretoria, South Africa
        • Netcare Unitas Hospital
      • Albacete, Spain
        • Hospital General de Albacete
      • Alicante, Spain
        • Hospital General de Alicante
      • Badajoz, Spain
        • Hospital Infanta Cristina - Badajoz
      • Badalona, Spain
        • Hospital G. Trias i Pujol (Badalona)
      • Barakaldo, Spain
        • Hospital de Cruces-Barakaldo
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital Vall d'Hebron
      • Barcelona, Spain
        • Bellvitge University Hospital
      • Barcelona, Spain
        • Hospital Sant Pau (Barcelona)
      • Barcelona, Spain
        • Hospital V. Hebrón
      • Bizkaia, Spain
        • Hospital de Galdakano
      • Burgos, Spain
        • Hospital General Universitario de Burgos
      • Caceres, Spain
        • Hospital San Pedro de Alcantara-Caceres
      • Cartagena, Spain
        • Hospital Santa Lucía de Cartagena
      • Cartagena, Spain
        • Universitario Santa Lucia (Hospital Nostra Señora Rossell) (Cartagena)
      • Cartagena (Murcia), Spain
        • Hospital Santa Lucía de Cartagena
      • Castellón, Spain
        • Hospital General Castellón
      • Ciudad Real, Spain
        • Hospital General Ciudad Real
      • Córdoba, Spain
        • Hospital de la Cruz Roja de Córdoba
      • Córdoba, Spain
        • Hospital Reina Sofia de Cordoba
      • Galdakao, Spain
        • Hospital de Galdakao
      • Gijón, Spain
        • Hospital Cabueñes (Gijón)
      • Guadalajara, Spain
        • Hospital Universitario de Guadalajara
      • Huelva, Spain
        • Hospital Juan Ramón Jimenez
      • La Coruña, Spain
        • Complexo Hospitalario Universitario A Coruña (CHUAC)
      • La Coruña, Spain
        • Hospital San Rafael (La Coruña)
      • Las Palmas De Gran Canaria, Spain
        • Hosp Universitario de Gran Canaria Dr. Negrin
      • León, Spain
        • Hospital de Leon
      • Logroño, Spain
        • Hospital San Pedro
      • Logroño, Spain
        • Hospital San Pedro (Logroño - La Rioja)
      • Lugo, Spain
        • Hospital Universitario Lucus Augusti (HULA)
      • Madrid, Spain
        • Hospital 12 Octubre
      • Madrid, Spain
        • Clinica La Luz
      • Madrid, Spain
        • Clínica San Fransisco de Asis (Madrid)
      • Madrid, Spain
        • Hospital Fundación Alcorcón
      • Madrid, Spain
        • Hospital La Luz
      • Madrid, Spain
        • Hospital Moncloa (Madrid)
      • Madrid, Spain
        • Hospital Moncloa
      • Majadahonda, Spain
        • Hospital Puerta de Hierro (Madrid)
      • Manises, Spain
        • Hospital Manises (Valencia)
      • Murcia, Spain
        • Hospital Virgen Arrixaca (Murcia)
      • Mérida, Spain
        • Hospital de Mérida
      • Oviedo, Spain
        • Universitario central de Asturias (Oviedo)
      • Oviedo, Spain
        • Universitario central de Asturias
      • Pamplona, Spain
        • Hospital De Navarra
      • San Juan, Spain
        • San Juan de Alicante
      • San Sebastián, Spain
        • Hospital Universitario Donostia
      • San Sebastián, Spain
        • Hospital de Donostia
      • Santander, Spain
        • Hospital Marques de Valdecilla
      • Santander, Spain
        • Hospital Marqués de Valdecilla, Santander
      • Santiago de Compostela, Spain
        • Hospital Clinico Universitario de Santiago de Compostela
      • Toledo, Spain
        • Hospital Virgen de la Salud
      • Toledo, Spain
        • Hospital Virgen de la Salud (Toledo)
      • Valencia, Spain
        • Clínico Universitario Valencia
      • Valladolid, Spain
        • Instituto Cardiologico Hospital Campo Grande (Valladolid)
      • Valladolid, Spain
        • Instituto Cardiologico Hospital Campo Grande
      • Vigo, Spain
        • Hospital Meixoeiro-MEDTEC (Vigo)
      • Vitoria, Spain
        • Hospital Txagorritxu
      • Zaragoza, Spain
        • Hospital Universitario Miguel Servet
      • Zaragoza, Spain
        • Hospital Clínico Lozano Blesa de Zaragoza
      • Gavle, Sweden
        • Gävle sjukhus
      • Malarsjukhuset, Sweden
        • Malarsjukshuet
      • Orebro, Sweden
        • sjukhuset Orebro
      • Skovde, Sweden
        • Skaraborgs Sjukhus
      • Skövde, Sweden
        • Skaraborgs sjukhus v Skövde
      • Sundvalls, Sweden
        • Sundvalls Sjukhus
      • Vasteras, Sweden
        • Vastmanlads Sjukhus
      • Västerås, Sweden
        • Västmanlads sjukhus Västerås
      • Örebro, Sweden
        • Universitets Sjukhuset I Örebro
      • Frauenfeld, Switzerland
        • Spital Thurgau AG
      • Genève, Switzerland
        • Hôpitaux Universitaires de Genève
      • Liestal, Switzerland
        • Kantonsspital Baselland
      • Lugano, Switzerland
        • Cardiocentro Ticino
      • Lugano, Switzerland
        • Cardiocenter Lugano, Ticino (TI)
      • Luzern, Switzerland
        • Kantonsspital Luzern
      • Meyrin Geneva, Switzerland
        • La Tour Hospital
      • Zürich, Switzerland
        • HerzGefässZentrum Zürich
      • Zürich, Switzerland
        • HerzGefässZentrum
      • Bangkok, Thailand
        • Paolo Memorial Hospital Phaholyothin
      • Bangkok, Thailand
        • Police General Hospital
      • Bangkok, Thailand
        • Ramkhamhaeng Hospital
      • Nakhon Navok, Thailand
        • HRH Princess Maha Chakri Siridhorn Medical Center
      • Nakhon Navok, Thailand
        • HRH Princess Maha Chakri Sirindhorn Medical Center (Nakornayok)
      • Nonthaburi, Thailand
        • Central Chest Institute of Thailand
      • Pathum Thani, Thailand
        • Phatara Thonburi Hospital
      • Udon Thani, Thailand
        • Udonthani HP.
      • Udonthani, Thailand
        • Udonthani Hospital
      • El Mourouj, Tunisia
        • Clinique Hannibal Lac 2_Dr. Mohamed Drissa
      • La Marsa, Tunisia
        • Clinique Générale et Cardiovasculaire de Tunis_Dr. Sami Bouziri
      • Sfax, Tunisia
        • Bassatine Clinic_Dr. Elyes Kharrat
      • Sfax, Tunisia
        • Polyclinique Bassatine Cite gardin Sfax_Dr. Zeineb Grati Guermazi
      • Sfax, Tunisia
        • Polyclinique El Bassatine SFAX_Dr. Sami Fourati
      • Sfax, Tunisia
        • Polyclinique El bassatine_Dr. Mohamed Najeh Abid
      • Sfax, Tunisia
        • Polyclinique El Bassatine_Dr. Ridha Ennouri
      • Tunis, Tunisia
        • Centre Urbain Nord_Dr. Salem Abdessalem
      • Tunis, Tunisia
        • Clinique Cartagène_Dr. Dhaker Lahidheb
      • Tunis, Tunisia
        • Clinique Général et Cardiovasculaire de Tunis_Dr. Saloua Trabelsi
      • Tunis, Tunisia
        • Clinique Générale et Cardiovasculaire de Tunis_Dr. Saloua TRABELSI
      • Tunis, Tunisia
        • Clinique Hannibal Lac 2_Gharbi Mostari
      • Tunis, Tunisia
        • Clinique Montplaisir_Dr. Badi Darghouth
      • Tunis, Tunisia
        • HU Mohamed Taher El Maâmouri
      • Tunis, Tunisia
        • Policlinique Taoufik_Jamel Langar
      • Tunis, Tunisia
        • Soukra Medical_Dr. Ben Chedli Tarek
      • Kiev, Ukraine
        • Heart Institute
      • Kiev, Ukraine
        • Institute of Heart (Ministry of Health)
      • Kiev, Ukraine
        • NAMS Amosov | Emergency Endovascular Surgery department
      • Kiev, Ukraine
        • NAMS Amosov | X-Ray diagnostics and invasive cardiology department
      • Kiev, Ukraine
        • National Institute of Cardiovascular Surgery NAMS
      • Kiev, Ukraine
        • National Institute of Surgery and Transplantology NAMS
      • Kiev, Ukraine
        • S.P.M.C. of Pediatric Cardiology and Cardiac Surgery
      • Kiev, Ukraine
        • Strazhesko Institute of Cardiology (National Scientific Centre)
      • Zaporizhzhya, Ukraine
        • Government institution Regional centre of cardiac and vessel disease
      • Abu Dhabi, United Arab Emirates
        • Al Noor Hospital-Airport Rd.
      • Abu Dhabi, United Arab Emirates
        • Lifecare Hospital
      • Dubai, United Arab Emirates
        • Rashid Hospital
      • Dubai, United Arab Emirates
        • Al Zahra Private hospital, Dubai
      • Dubai, United Arab Emirates
        • Belhoul Speciality Hospital
      • Dubai, United Arab Emirates
        • Dr. Sulaiman Al Habib Hospital
      • Dubai, United Arab Emirates
        • Dubai Hospital
      • Dubai, United Arab Emirates
        • Iranian hospital
      • Dubai, United Arab Emirates
        • Prime Hospital
      • Sharja, United Arab Emirates
        • Al Qassimi Hopsital
      • Basildon, United Kingdom
        • Essex Cardiothoracic Centre
      • Bath, United Kingdom
        • Royal United Hospital, Bath
      • Bedford, United Kingdom
        • Bedford Hospital
      • Birmingham, United Kingdom
        • Queen Elizabeth Hospital
      • Birmingham, United Kingdom
        • Sandwell and West Birmingham Hospitals
      • Blackburn, United Kingdom
        • Royal Blackburn Hospital
      • Blackpool, United Kingdom
        • Blackpool Victoria Hospital
      • Bournemouth, United Kingdom
        • Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
      • Bradford, United Kingdom
        • Bradford Teaching Hospitals
      • Brighton, United Kingdom
        • Royal Sussex Hospital, Brighton
      • Cardiff, United Kingdom
        • University Hospital Wales
      • Croydon, United Kingdom
        • Croydon University Hospital
      • Derby, United Kingdom
        • Royal Derby Hospital
      • Dorchester, United Kingdom
        • Dorset County Hospital
      • Eastbourne, United Kingdom
        • Eastbourne and Conquest Hospitals
      • Freeman, United Kingdom
        • Freeman Hospital
      • Isleworth, United Kingdom
        • West Middlesex Hospital
      • Kettering, United Kingdom
        • Kettering General Hospital
      • Leicester, United Kingdom
        • University Hospitals of Leicester
      • Lincoln, United Kingdom
        • Lincoln County Hospital
      • London, United Kingdom
        • Royal Free Hospital
      • London, United Kingdom
        • The Royal Free Hospital
      • Manchester, United Kingdom
        • University Hospital of South Manchester
      • Middlesbrough, United Kingdom
        • James Cook University Hospital
      • New Cross, United Kingdom
        • Wolverhampton
      • Newport, United Kingdom
        • Royal Gwent Hospital, Newport
      • Northwick Park, United Kingdom
        • Northwick Park Hospital
      • Norwich, United Kingdom
        • Norfolk and Norwich University Hospital
      • Nottingham, United Kingdom
        • Nottingham University Hospitals - Queen's Medical Centre
      • Nottingham, United Kingdom
        • Queens medical center Nottingham
      • Plymouth, United Kingdom
        • Bircham Park Offices Plymouth
      • Plymouth, United Kingdom
        • Plymouth Hospital
      • Reading, United Kingdom
        • Royal Berkshire
      • Salisbury, United Kingdom
        • Salisbury District Hospital
      • Sheffield, United Kingdom
        • Sheffield Teaching Hospital
      • Stevenage, United Kingdom
        • Lister Hospital, Stevenage
      • Stoke-on-Trent, United Kingdom
        • Royal Stoke University Hospital
      • Sutton in Ashfield, United Kingdom
        • King's Mill Hospital
      • Truro, United Kingdom
        • Royal Cornwall Hospitals
      • Tunbridge Wells, United Kingdom
        • Tunbridge Wells Hospital
      • Walsgrave, United Kingdom
        • Coventry and Warwickshire
      • Wigan, United Kingdom, WN6 9EP
        • Wrightington Hospital
      • Worcestershire, United Kingdom
        • Worcestershire Acute Hospitals
      • Worthing, United Kingdom
        • Worthing Hospital, West Sussex
      • Wycombe, United Kingdom
        • Buckinghamshire, Wycombe
    • London
      • Chelsea, London, United Kingdom, SW3 5UE
        • Royal Brompton and Harefield
      • Tashkent, Uzbekistan
        • Republic Specialized Center of Surgery
      • Hò Chi Minh City, Vietnam
        • Thong Nhat HOSPITAL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patient 18 years or older eligible for percutaneous coronary intervention using DES

Description

Inclusion Criteria:

  • 18 years or older
  • eligible for percutaneous coronary intervention using DES (and RVD matches available Ultimaster DES sizes)
  • informed about the nature of the study and agreess to its provisionss and 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:

  • following instruction for use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TLF
Time Frame: 1 year
Target Lesion Failure defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically drive target lesion revascularization (TLR) at 1 year.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
success endpoints
Time Frame: 3 months and 1 year
Procedural success and Device success
3 months and 1 year
safety endpoints
Time Frame: 3months and 1 year
cardiac death / mi (peri and post procedural) stent thrombosis (according to ARC definitions) acute/subacute/late primary/secondary Composite endpoint of cardiac death and post procedural MI Composite endpoint of cardiac death , post procedural MI and stent thrombosis rate during the course of DAPT versus the same events after cessaton of DAPT Major vascular and bleeding complications
3months and 1 year
efficacy and patient oriented (composite) endpoints
Time Frame: 3months and 1 year
TLR rate (re-pci/CABG) TLF rate Target Vessel Failure rate (TVF) defined as target vessel revascularization target vessel related q-wave or non q-wave myocardial infarction, or cardiax death that could ot be clearly attributed to a veessl other than the target vessel Patient oriented composite endpoint (POCE) defined as any cause of mortality, mi (q-wave and non qwave) or any TVR
3months and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Vladimir Borovicanin, MD, Terumo Europe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

July 9, 2014

First Submitted That Met QC Criteria

July 9, 2014

First Posted (Estimate)

July 11, 2014

Study Record Updates

Last Update Posted (Actual)

October 8, 2019

Last Update Submitted That Met QC Criteria

October 6, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • T123E2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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