Coronary Artery Diseasee-UltimasterNCT02188355
Prospective, Single-arm, Multi Centre Observations Ultimaster Des Registry
An observational study of Coronary Artery Disease, run by Terumo Europe N.V. at 462 sites in 50 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 37,000 participants
- Where
- 462 sitesin 50 countries
- Study dates
- Jun 2014to Jun 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient 18 years or older eligible for percutaneous coronary intervention using DES
Who may be able to join
- 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.
Who cannot join
- following instruction for use
Trial locations and contacts
462 sites in 50 countries.
462 sites in 50 countries
Spain60 sites
Complexo Hospitalario Universitario A Coruña (CHUAC)
A Coruña
Hospital San Rafael (La Coruña)
A Coruña
Hospital general de Albacete
Albacete
Hospital General de Alicante
Alicante
Hospital Infanta Cristina - Badajoz
Badajoz
Hospital G. Trias i Pujol (Badalona)
Badalona
Hospital de Cruces-Barakaldo
Barakaldo
Bellvitge University Hospital
Barcelona
Hospital del Mar
Barcelona
Hospital Sant Pau (Barcelona)
Barcelona
Hospital V. Hebrón
Barcelona
Hospital Vall d'Hebron
Barcelona
Hospital de Galdakano
Bizkaia
Hospital General Universitario de Burgos
Burgos
Hospital San Pedro de Alcantara-Caceres
Cáceres
Hospital Santa Lucia de Cartagena
Cartagena
Universitario Santa Lucia (Hospital Nostra Señora Rossell) (Cartagena)
Cartagena
Hospital Santa Lucia de Cartagena
Cartagena (Murcia)
Hospital General Castellón
Castellon
Hospital General Ciudad Real
Ciudad Real
Hospital de la Cruz Roja de Córdoba
Córdoba
Hospital Reina Sofia de Córdoba
Córdoba
Hospital de Galdakao
Galdakao
Hospital Cabueñes (Gijón)
Gijón
Hospital Universitario de Guadalajara
Guadalajara
Hospital Juan Ramón Jiménez
Huelva
Hosp Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria
Hospital de León
León
Hospital San Pedro (Logroño - La Rioja)
Logroño
Hospital San Pedro
Logroño
Hospital Universitario Lucus Augusti (HULA)
Lugo
Clinica La Luz
Madrid
Clínica San Fransisco de Asis (Madrid)
Madrid
Hospital 12 Octubre
Madrid
Hospital Fundacion Alcorcon
Madrid
Hospital La Luz
Madrid
Hospital Moncloa (Madrid)
Madrid
Hospital Moncloa
Madrid
Hospital Puerta de Hierro (Madrid)
Majadahonda
Hospital Manises (Valencia)
Manises
Hospital de Mérida
Mérida
Hospital Virgen Arrixaca (Murcia)
Murcia
Universitario central de Asturias (Oviedo)
Oviedo
Universitario central de Asturias
Oviedo
Hospital de Navarra
Pamplona
San Juan de Alicante
San Juan
Hospital de Donostia
San Sebastián
Hospital Universitario Donostia
San Sebastián
Hospital Marqués de Valdecilla, Santander
Santander
Hospital Marqués de Valdecilla
Santander
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela
Hospital Virgen De La Salud (Toledo)
Toledo
Hospital Virgen De La Salud
Toledo
Clínico Universitario Valencia
Valencia
Instituto Cardiologico Hospital Campo Grande (Valladolid)
Valladolid
Instituto Cardiologico Hospital Campo Grande
Valladolid
Hospital Meixoeiro-MEDTEC (Vigo)
Vigo
Hospital Txagorritxu
Vitoria-Gasteiz
Hospital Clínico Lozano Blesa de Zaragoza
Zaragoza
Hospital Universitario Miguel Servet
Zaragoza
France48 sites
CHU Angers
Angers
Hopital Européen de Paris La Roseraie
Aubervilliers
Clinique Rhône Durance
Avignon
GCS Cardiologique de Bayonne
Bayonne
Clinique St Augustin Bordeaux-Centre d'exploration-chirurgie
Bordeaux
CHU Caen
Caen
Hopital Privé Saint Martin
Caen
CHU Clermont-Ferrand
Clermont-Ferrand
Pôle Santé République Clermont Ferrand
Clermont-Ferrand
Hopital Albert Schweitzer GHCA Colmar
Colmar
CH Sud Francilien
Corbeil-Essonnes
Clinique de Fontaine
Dijon
Groupement mutualiste de Grenoble
Grenoble
CH Haguenau
Haguenau
CH de Marne la Vallée
Jossigny
CHD Vendée La Roche sur Yon
La Roche-sur-Yon
Groupe Hospitalier de la Rochelle Ré Aunis
La Rochelle
CH Louis Pasteur-Le Coudray
Le Coudray
Hopital privé La Louviere-Lille
Lille
CH St Joseph St Luc Lyon
Lyon
Hopital Privé Jacques Cartier Massy
Massy
Clinique du Pont de Chaume Montauban
Montauban
Clinique du Milénaire
Montpellier
CH Montreuil
Montreuil
Clinique Diaconat Fonderie Mulhouse
Mulhouse
Clinique Louis Pasteur Essey les Nancy
Nancy
Le Confluent Nouvelles Cliniques Nantaises
Nantes
Clinique Ambroise Paré
Neuilly-sur-Seine
Polyclinique les Fleurs
Ollioules
CHR Orléans
Orléans
Groupe Hopitalier Paris Saint Joseph
Paris
Centre Hospitalier de Pau
Pau
Hopital privé St Martin Pessac (DR Levy)
Pessac
Hôpital Privé St Martin de Pessac
Pessac
CHU de Poitiers
Poitiers
CH René Dubos Pontoise
Pontoise
CHIC Quimper
Quimper
Hopiatl Privé Claude Galien Quincy
Quincy-sous-Sénart
Clinique Saint-Laurent Rennes
Rennes
Clinique ST Hilaire Rouen
Rouen
CH Yves le Foll - Saint Brieuc
Saint-Brieuc
Institut Arnault Tzanck St Laurent du Var
Saint-Laurent-du-Var
CH La Timone Marseille
Saint-Pierre
CH Général de Saint Quentin
Saint-Quentin
Nouvel Hopital Civil de Strasbourg
Strasbourg
Clinique Saint Joseph
Trélazé
CH de Valence
Valence
CH Bretagne Atlantique
Vannes
United Kingdom46 sites
Essex Cardiothoracic centre
Basildon
Royal United Hospital, Bath
Bath
Bedford Hospital
Bedford
Queen Elizabeth Hospital
Birmingham
Sandwell and West Birmingham Hospitals
Birmingham
Royal Blackburn Hospital
Blackburn
Blackpool Victoria Hospital
Blackpool
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Bournemouth
Bradford teaching hospitals
Bradford
Royal Sussex Hospital, Brighton
Brighton
University Hospital Wales
Cardiff
Royal Brompton and Harefield
Chelsea, London, SW3 5UE
Croydon University Hospital
Croydon
Royal Derby Hospital
Derby
Dorset County Hospital
Dorchester
Eastbourne and Conquest Hospitals
Eastbourne
Freeman Hospital
Freeman
Buckinghamshire, Wycombe
High Wycombe
West Middlesex Hospital
Isleworth
Kettering General Hospital
Kettering
University Hospitals of Leicester
Leicester
Lincoln County Hospital
Lincoln
Royal Free Hospital
London
The Royal Free Hospital
London
University Hospital of South Manchester
Manchester
James Cook University Hospital
Middlesbrough
Wolverhampton
New Cross
Royal Gwent Hospital, Newport
Newport
Northwick Park Hospital
Northwick Park
Norfolk and Norwich University Hospital
Norwich
Nottingham University Hospitals - Queen's Medical Centre
Nottingham
Queens medical center Nottingham
Nottingham
Bircham Park Offices Plymouth
Plymouth
Plymouth Hospital
Plymouth
Royal Berkshire
Reading
Tunbridge Wells Hospital
Royal Tunbridge Wells
Salisbury District Hospital
Salisbury
Sheffield teaching hospital
Sheffield
Lister Hospital, Stevenage
Stevenage
Royal Stoke University Hospital
Stoke-on-Trent
King's Mill Hospital
Sutton in Ashfield
Royal Cornwall Hospitals
Truro
Coventry and Warwickshire
Walsgrave on Sowe
Wrightington Hospital
Wigan, WN6 9EP
Worcestershire Acute Hospitals
Worcestershire
Worthing Hospital, West Sussex
Worthing
Japan26 sites
Kansai Rosai Hospital
Amagasaki Hyougo
Kokura Memorial Hospital
Fukuoka
Iwaki Kyoritsu General Hospital
Fukushima
Tokai University Hachiouji Hospital
Hachiōji
Hakodate Municipal Hospital
Hakodate Hokkaido
Seirei Hamamatsu General Hospital
Hamamatsu
Kakogawa East City Hospital
Kakogawa
Shonan Kamakura General Hospital
Kanagawa
Komaki City Hospital
Komaki Aichi
Kyoto Katsura Hospital
Kyoto
Gunma Prefectural Cardiovascular Center
Maebashi
Mie Heart Center
Mie
Osaka General Medical Center
Osaka
Sakurabashi Watanabe Hospital
Osaka
Saitama Cardiovascular and Respiratory Center
Saitama
Mimihara General Hospital
Sakai
Osaka Rosai Hospital
Sakai Osaka
Sapporo Higashi Tokushukai Hospital
Sapporo Hokkaido
Saiseikai Senri Hospital
Suita
Okamura Memorial Hospital
Suntougun Shizuoka
Higashi Takarazuka Satoh Hospital
Takarazuka Hyougo
Kouseikai Takai Hospital
Tennri Nara
Saiseikai Yamaguchi General Hospital
Yamaguchi
Saiseikai Yokohama City Eastern Hospital
Yokohama
Seirei Yokohama Hospital
Yokohama
Showa University Fujigaoka Hospital
Yokohama Kanagawa
Bulgaria19 sites
"Mhat Puls" Ad
Blagoevgrad
City clinic Burgas
Burgas
MBAL Haskovo AD
Haskovo
Cardiolife-Lovech
Lovech
Mbal Montana City Clinic Sveti Georgi
Montana
MBAL St. Karidad
Plovdiv
MHAT Plovdiv
Plovdiv
University Hospital Sveti Georgi
Plovdiv
City clinic University Multi-Profile Hospital for Acute Care,Sofia
Sofia
MBAZ-II-Sofia
Sofia
MHATEM N.I.Pirogov
Sofia
National Heart Hospital
Sofia
Tokuda Hospital
Sofia
UMHAT Alexandrovska
Sofia
UMHAT St.Ekaterina
Sofia
Trakiya Hospital
Stara Zagora
Umbal Stojan Kirkovich
Stara Zagora
Specialized Cardiology Hospital for Active Treatment
Varna
MBAL Sveta Petka Vidin
Vidin
Kazakhstan16 sites
Aktobe Regional Hospital
Aktobe
Medical University Clinic West Kazakhstan
Aktobe
Almaty city cardio center
Almaty
National Surgery Center Almat
Almaty
City Hospital #2
Astana
JSC Nat. Scient. Cardiosurgery Ctr.
Astana
National Scientific Medical Research Center JSC
Astana
Karagandy Regional Cardiac Center
Karaganda
Regional Cardiosurgery Center
Karaganda
Akmola Regional Hospital
Kokshetau
Pavlodar Regional Cardiologic center
Pavlodar
Cardiology Center Petropavl
Petropavl
Rudnyi City Hospital
Rudnyi
University Hospital of Semey
Semey
Shymkent Regional Cardiology Center
Shymkent
Clinical Center of Cardiac Surgery and Transplantation
Taraz
Tunisia16 sites
Clinique Hannibal Lac 2_Dr. Mohamed Drissa
El Mourouj
Clinique Générale et Cardiovasculaire de Tunis_Dr. Sami Bouziri
La Marsa
Bassatine Clinic_Dr. Elyes Kharrat
Sfax
Polyclinique Bassatine Cite gardin Sfax_Dr. Zeineb Grati Guermazi
Sfax
Polyclinique El Bassatine SFAX_Dr. Sami Fourati
Sfax
Polyclinique El bassatine_Dr. Mohamed Najeh Abid
Sfax
Polyclinique El Bassatine_Dr. Ridha Ennouri
Sfax
Centre Urbain Nord_Dr. Salem Abdessalem
Tunis
Clinique Cartagène_Dr. Dhaker Lahidheb
Tunis
Clinique Général et Cardiovasculaire de Tunis_Dr. Saloua Trabelsi
Tunis
Clinique Générale et Cardiovasculaire de Tunis_Dr. Saloua TRABELSI
Tunis
Clinique Hannibal Lac 2_Gharbi Mostari
Tunis
Clinique Montplaisir_Dr. Badi Darghouth
Tunis
HU Mohamed Taher El Maâmouri
Tunis
Policlinique Taoufik_Jamel Langar
Tunis
Soukra Medical_Dr. Ben Chedli Tarek
Tunis
Egypt15 sites
Police Hospital
Alexandria
Al Hayat Hospital
Cairo
Al Nakheel Hospital
Cairo
Dr Ahmed Abdel Aziz Multicenter
Cairo
Dr Hisham Ammar Multicenter
Cairo
Dr Hussien Heshmat - As Salam International Hospital
Cairo
Dr. Tarek Rashid
Cairo
Dr.Hazem Al Guindi
Cairo
El Marwa Hospital
Cairo
Italian Hospital
Cairo
Nile Badrawy Hospital
Cairo
Sheraton Hospital for Medical Services
Cairo
Wadi El Neel Hospital
Cairo
Um El Korra Hospital
El Gharbeya
L-Fouad Cardiac Center
Menofia
India15 sites
Kamalnayan Bajaj Hospital
Aurangabad
MMM, Chennai
Chennai
G. Kuppuswamy Naidu Memorial Hospital (GKNM), Coimbatore
Coimbatore
Medanta Hospital, Delhi
Delhi
Care Hospital, Hyderabad
Hyderabad
SMS Hospital, Jaipur
Jaipur
BM Birla, Kolkata
Kolkata
KMC, Mangalore
Mangalore
Fortis Hospital, Mohali
Mohali
H.J. Doshi Ghatkopar Hindusabha Hospital
Mumbai
Hiranandani Hospital, Mumbai
Mumbai
Wockhardt Hospital, Nagpur
Nagpur
Maharaja Agrasen Hospital, New Delhi
New Delhi
Max Super Speciality Hospital, Saket, Delhi
New Delhi
SCTIT, Trivanderum
Trivanderum
Netherlands14 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
Meander Amersfoort
Amersfoort
Rijnstate
Arnhem
Amphia Ziekenhuis
Breda
Albert Schweitzer Ziekenhuis
Dordrecht
Catharina Hospital
Eindhoven
Catharina Ziekenhuis
Eindhoven
Scheper Ziekenhuis
Emmen
Medisch Spectrum Twente
Enschede
Medisch Centrum Leeuwarden
Leeuwarden
Maasstad Ziekenhuis
Rotterdam
Zorgzaam Ziekenhuis Zeeuws-Vlaanderen
Terneuzen
Medisch Centrum Haaglanden
The Hague
VieCuri Medical Centre
Venlo
Belgium12 sites
OLVZ Aalst, Onze Lieve Vrouw Ziekenhuis vzw-Campus Aalst
Aalst
Olvz Aalst
Aalst
Imelda Ziekenhuis - Bonheiden
Bonheiden
Imelda Ziekenhuis
Bonheiden
Cliniques Saint-Luc
Brussels
CHU Charleroi
Charleroi
AZ Sint Lucas
Ghent
Epicura-Hornu
Hornu
Jan Yperman Ziekenhuis
Ieper
CHR de la Citadelle
Liège
Hôpital Ambroise Paré de Mons
Mons
CHU UCL Mont Godinne Namur
Yvoir
Brazil11 sites
Hospital Felicio Rocho
Belo Horizonte
Unimed Joinville
Joinville
Hospital Monte Sinai
Juiz de Fora
UNICOR
Linhares
Paraná Medical Research Center
Maringá
Eurolatino Natal Medical Research
Natal
Hospital São Vicente de Paulo
Passo Fundo
Hospital Moinhos de Vento
Porto Alegre
Hospital e Maternidade Dr. Christóvão da Gama
Santo André
Beneficência Portuguesa de São Paulo
São Paulo
Hospital Santa Cruz
São Paulo
United Arab Emirates10 sites
Al Noor Hospital-Airport Rd.
Abu Dhabi
LifeCare Hospital
Abu Dhabi
Al Zahra Private hospital, Dubai
Dubai
Belhoul Speciality Hospital
Dubai
Dr. Sulaiman Al Habib Hospital
Dubai
Dubai Hospital
Dubai
Iranian hospital
Dubai
Prime Hospital
Dubai
Rashid Hospital
Dubai
Al Qassimi Hopsital
Sharjah city
Indonesia9 sites
Medistra Hospital
Jakarta
National Cardiovascular Center Harapan Kita
Jakarta Barat
RSUPN Cipto Mangunkusumo
Jakarta Pusat
RSUP Fatmawati General Hospital
Jakarta Selatan
Binawaluya Cardiac Center
Jakarta Timur
Awal Bros Hospital
Makassar
Dr. Wahidin Sudirohusodo General Hospital
Makassar
Saiful Anwar Hospital
Malang
Dr. Soetomo General Hospital
Surabaya
Sweden9 sites
Gavle Sjukhus
Gävle
Malarsjukshuet
Malarsjukhuset
sjukhuset Orebro
Örebro
Universitets Sjukhuset I Örebro
Örebro
Skaraborgs sjukhus v Skövde
Skövde
Skaraborgs Sjukhus
Skövde
Sundvalls Sjukhus
Sundvalls
Vastmanlads Sjukhus
Västerås
Västmanlads sjukhus Västerås
Västerås
Switzerland9 sites
Spital Thurgau AG
Frauenfeld
Hopitaux Universitaires de Genève
Geneva
Kantonsspital Baselland
Liestal
Kantonsspital Luzern
Lucerne
Cardiocenter Lugano, Ticino (TI)
Lugano
Cardiocentro Ticino
Lugano
La Tour Hospital
Meyrin Geneva
HerzGefässZentrum Zürich
Zurich
HerzGefässZentrum
Zurich
Thailand9 sites
Paolo Memorial Hospital Phaholyothin
Bangkok
Police General Hospital
Bangkok
Ramkhamhaeng Hospital
Bangkok
HRH Princess Maha Chakri Siridhorn Medical Center
Nakhon Navok
HRH Princess Maha Chakri Sirindhorn Medical Center (Nakornayok)
Nakhon Navok
Central Chest Institute of Thailand
Nonthaburi
Phatara Thonburi Hospital
Pathum Thani
Udonthani Hospital
Udon Thani
Udonthani HP.
Udon Thani
Ukraine9 sites
Heart Institute
Kiev
Institute of Heart (Ministry of Health)
Kiev
NAMS Amosov | Emergency Endovascular Surgery department
Kiev
NAMS Amosov | X-Ray diagnostics and invasive cardiology department
Kiev
National Institute of Cardiovascular Surgery NAMS
Kiev
National Institute of Surgery and Transplantology NAMS
Kiev
S.P.M.C. of Pediatric Cardiology and Cardiac Surgery
Kiev
Strazhesko Institute of Cardiology (National Scientific Centre)
Kiev
Government institution Regional centre of cardiac and vessel disease
Zaporizhzhya
Argentina8 sites
Fundación Favaloro
Buenos Aires
Hospital San Juan de Dios
Buenos Aires
Hospital Universitario Austral
Buenos Aires
Instituto Cardiovascular de Buenos Aires
CABA - Buenos Aires
Clinica Centro Médico Privado Junin
Junín
Clinica Monte Grande
Monte Grande
Instituto Cardiovascular de Rosario
Rosario
Sanatorio San Miguel
San Miguel
Chile8 sites
Hospital Antofagasta
Antofagasta
Hospital Guillermo Grant Benavente
Concepción
Hospital Regional Puerto Montt
Port Montt
Clinica Bicentenario
Region Metropolitana
Clinica Santa Maria
Santiago
Hospital San Borja Arriaran
Santiago
Hospital San Juan de Dios
Santiago
Hospital Van Buren
Valparaíso
South Africa8 sites
Dr JCW Badenhorst - Netcare Unitas Hospital
Centurion
Unitas Hospital - Dr. Ebrahim
Centurion
Unitas Hospital
Centurion
Milpark Hospital
Johannesburg
Netcare Union Hospital
Johannesburg
Ethekwini Hospital & Heart centre
Newlands
Netcare Greenacres Hospital
Port Elizabeth
Netcare Unitas Hospital
Pretoria
Armenia6 sites
Medical center Gyumri CJSC
Gyumri, 3103
"QANCOR" cardiovascular MC LLC
Yerevan
Astghik Medical Center (Natali Farm)
Yerevan
QANCOR Cardiovascular MC LLC
Yerevan
Republican Medical Center Armenia CJSC
Yerevan
Yerevan State medical University Hospital
Yerevan
Hungary6 sites
Semmelweis University
Budapest
Hospital Pándy Kálmán
Gyula
Moritz Kaposi General Hospital
Kaposvár
Szatmar-Szabolcs-Bereg county hospital and university teaching hospital
Nyíregyháza
Pecs University
Pécs
Markusovszky University Teaching Hospital
Szombathely
Malaysia6 sites
Hospital Sultanah Bahiyah
Alor Setar, Kedah
Hospital Serdang
Kajang
Desa Park City
Kuala Lumpur
HSC Medical Center
Kuala Lumpur
Hospital Tengku Ampuan Afzan
Kuantan
UiTM Sg. Buloh Campus
Sungai Buloh
Serbia6 sites
Cardiology Clinic, Clinical Centre of Serbia
Belgrade
Cardiovascular Institute Dedinje
Belgrade
CHC Bezanijska kosa
Belgrade
KBC Zvezdara
Belgrade
Institute of cardiovascular diseases Vojvodina
Kamenitz
Clinical Center Kragujevac
Kragujevac
Austria5 sites
Medizinische Universität Graz
Graz
AKh Linz
Linz
Hanusch Krankenhaus der Wiener Gebietskrankenkasse
Vienna
Krankenanstalt Rudolfstiftung der Stadt Wien
Vienna
Vienna General Hospital
Vienna
Colombia5 sites
Clinica Marly
Bogotá
Clinica Shaio
Bogotá
Fundación Cardiovascular de Colombia
Bucaramanga
Instituto del corazón de Bucaramanga
Bucaramanga
Centro Cardiovascular de Caldas
Manizales
Czechia5 sites
Fakultni nemocnice u svate Anny v Brne
Brno
Karlovarská Krajská nemocnice
Karlovy Vary
FNKV
Prague, Srobarova
Kardiologie na Bulovce
Prague
Krajska nemocnice t. Bati
Zlín
Israel4 sites
Rambam Medical Center
Haifa
Galilee Medical Center
Nahariya
Ziv M.C
Safed
Assaf Harofeh Medical Center
Tzrifin
Morocco4 sites
Clinique Achifaa de Casablanca
Casablanca
Clinique Grant Atlas
Marrakesh
CLINIQUE INTERNATIONALE de Marrakech
Marrakesh
Cherradi_Clinique Agdal
Rabat
Poland4 sites
Miedziowe Centrum Zdrowia
Lubin
Szpital Kliniczny Przemienienia Panskiego UM im. K. Marcinkowskiego w Poznaniu
Poznan
Infant Jesus Teaching Hospital
Warsaw
Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego
Warsaw
Romania4 sites
Clinicile ICCO
Brasov
Centrele de Exelenta ARES
Constanța
Spitalul Judetean de Urgenta Sibiu
Sibiu
Cordismed SRL
Timișoara
Georgia3 sites
Diagnostic Services Ltd. Cardio Clinic
Tbilisi
Helsicore Clinic
Tbilisi
JoAnn Medical Center
Tbilisi
Ireland3 sites
Cork University Hospital
Cork
University Hospital Galway
Galway
University Hospital Limerick
Limerick
Mexico3 sites
Fray Juan de San Miguel
Michoacán
Clinica Hospital San Jose de Navojoa SA de CV
Sonora
Hospital Star Médica Merida
Yucatán
Estonia2 sites
East-Tallinn Central Hospital
Tallinn
North Estonia Medical Center
Tallinn
Lithuania2 sites
LSMU Kauno Klinikos
Kaunas
Klaipeda Seamen's Hospital
Klaipėda
North Macedonia2 sites
City General Hospital 8th September Skopje
Skopje
University Clinic of Cardiology
Skopje
Saudi Arabia2 sites
Prince Abdullah Bin Abdulaziz Cardiac Center
North Region Arar KSA
Dallah Hospital
Riyadh
Bangladesh1 site
National Heart Foundation Hospital and Research Institute
Dhākuli
Slovakia1 site
Stredodlovensky Ustav Srdcovych A Cievnych Chorob
Banská Bystrica
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Keywords
- Ultimaster, registry, DES, DAPT
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
TLF
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.
Measured: 1 year
Secondary outcomes (3)
success endpoints
Procedural success and Device success
Measured: 3 months and 1 year
safety endpoints
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
Measured: 3months and 1 year
efficacy and patient oriented (composite) endpoints
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
Measured: 3months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 37,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Terumo Europe N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vladimir Borovicanin, MD, Study director, Terumo Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188355
- Sponsor's protocol ID
- T123E2
- Acronym
- e-Ultimaster
- Status last verified
- Oct 2019
- First submitted
- 9 Jul 2014
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Mamas MA, Roffi M, Frobert O, Chieffo A, Beneduce A, Matetic A, Tonino PAL, Paunovic D, Jacobs L, Debrus R, El Aissaoui J, van Leeuwen F, Kontopantelis E. Predicting target lesion failure following percutaneous coronary intervention through machine learning risk assessment models. Eur Heart J Digit Health. 2023 Aug 31;4(6):433-443. doi: 10.1093/ehjdh/ztad051. eCollection 2023 Dec.
PubMed 38045434Kobo O, Saada M, von Birgelen C, Tonino PAL, Iniguez-Romo A, Frobert O, Halabi M, Oemrawsingh RM, Polad J, IJsselmuiden AJJ, Roffi M, Aminian A, Mamas MA, Roguin A. Impact of multisite artery disease on clinical outcomes after percutaneous coronary intervention: an analysis from the e-Ultimaster registry. Eur Heart J Qual Care Clin Outcomes. 2023 Jun 21;9(4):417-426. doi: 10.1093/ehjqcco/qcac043.
PubMed 35876646Cimci M, Polad J, Mamas M, Iniguez-Romo A, Chevalier B, Abhaichand R, Aminian A, Roguin A, Maluenda G, Angioi M, Cassel G, Kuramitsu S, Jacobs L, Debrus R, Malik F, Hildick-Smith D, Laanmets P, Roffi M; e-ULTIMASTER investigators. Outcomes and regional differences in practice in a worldwide coronary stent registry. Heart. 2022 Jul 27;108(16):1310-1318. doi: 10.1136/heartjnl-2021-320116.
PubMed 35012960
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Arm, Multi-centre, Observational Registry to Further Validate Safety and Efficacy of the Ultimaster Des System in Unselected Patients Representing Everyday Clinical Practice
- ClinicalTrials.gov ID
- NCT02188355
- Acronym / sponsor ID
- e-Ultimaster / T123E2
- Conditions
- Coronary Artery Disease
- Keywords
- Ultimaster, registry, DES, DAPT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 37,000 participants (estimated)
- Lead sponsor
- Terumo Europe N.V.Industry (pharma, biotech, devices)
- Study start
- Jun 2014 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient 18 years or older eligible for percutaneous coronary intervention using DES
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- following instruction for use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
success endpoints
Time frame: 3 months and 1 year
safety endpoints
Time frame: 3months and 1 year
efficacy and patient oriented (composite) endpoints
Time frame: 3months and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Derived from this study: PubMed 38045434Mamas MA, Roffi M, Frobert O, Chieffo A, Beneduce A, Matetic A, Tonino PAL, Paunovic D, Jacobs L, Debrus R, El Aissaoui J, van Leeuwen F, Kontopantelis E. Predicting target lesion failure following percutaneous coronary intervention through machine learning risk assessment models. Eur Heart J Digit Health. 2023 Aug 31;4(6):433-443. doi: 10.1093/ehjdh/ztad051. eCollection 2023 Dec.
- Derived from this study: PubMed 35876646Kobo O, Saada M, von Birgelen C, Tonino PAL, Iniguez-Romo A, Frobert O, Halabi M, Oemrawsingh RM, Polad J, IJsselmuiden AJJ, Roffi M, Aminian A, Mamas MA, Roguin A. Impact of multisite artery disease on clinical outcomes after percutaneous coronary intervention: an analysis from the e-Ultimaster registry. Eur Heart J Qual Care Clin Outcomes. 2023 Jun 21;9(4):417-426. doi: 10.1093/ehjqcco/qcac043.
- Derived from this study: PubMed 35012960Cimci M, Polad J, Mamas M, Iniguez-Romo A, Chevalier B, Abhaichand R, Aminian A, Roguin A, Maluenda G, Angioi M, Cassel G, Kuramitsu S, Jacobs L, Debrus R, Malik F, Hildick-Smith D, Laanmets P, Roffi M; e-ULTIMASTER investigators. Outcomes and regional differences in practice in a worldwide coronary stent registry. Heart. 2022 Jul 27;108(16):1310-1318. doi: 10.1136/heartjnl-2021-320116.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Borovicanin, MD study director
Terumo Europe
462 sites in 50 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Terumo Europe N.V. at 462 sites in 50 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 462 sites in Spain, France, United Kingdom, Japan, Bulgaria and 45 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TLF (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02188355, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.