AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

Other trials in Spain

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

Other trials in France

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

Other trials in United Kingdom

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

Other trials in Japan

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

Other trials in Bulgaria

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

Other trials in Kazakhstan

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

Other trials in Tunisia

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

Other trials in Egypt

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

Other trials in India

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

Other trials in Netherlands

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

Other trials in Belgium

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

Other trials in Brazil

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

Other trials in United Arab Emirates

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

Other trials in Indonesia

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

Other trials in Sweden

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

Other trials in Switzerland

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

Other trials in Thailand

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

Other trials in Ukraine

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

Other trials in Argentina

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

Other trials in Chile

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

Other trials in South Africa

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

Other trials in Armenia

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

Other trials in Hungary

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

Other trials in Malaysia

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

Other trials in Serbia

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

Other trials in Austria

Colombia5 sites
  • Clinica Marly

    Bogotá

  • Clinica Shaio

    Bogotá

  • Fundación Cardiovascular de Colombia

    Bucaramanga

  • Instituto del corazón de Bucaramanga

    Bucaramanga

  • Centro Cardiovascular de Caldas

    Manizales

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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

Other trials in Czechia

Israel4 sites
  • Rambam Medical Center

    Haifa

  • Galilee Medical Center

    Nahariya

  • Ziv M.C

    Safed

  • Assaf Harofeh Medical Center

    Tzrifin

Other trials in Israel

Morocco4 sites
  • Clinique Achifaa de Casablanca

    Casablanca

  • Clinique Grant Atlas

    Marrakesh

  • CLINIQUE INTERNATIONALE de Marrakech

    Marrakesh

  • Cherradi_Clinique Agdal

    Rabat

Other trials in Morocco

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

Other trials in Poland

Romania4 sites
  • Clinicile ICCO

    Brasov

  • Centrele de Exelenta ARES

    Constanța

  • Spitalul Judetean de Urgenta Sibiu

    Sibiu

  • Cordismed SRL

    Timișoara

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Georgia3 sites
  • Diagnostic Services Ltd. Cardio Clinic

    Tbilisi

  • Helsicore Clinic

    Tbilisi

  • JoAnn Medical Center

    Tbilisi

Other trials in Georgia

Ireland3 sites
  • Cork University Hospital

    Cork

  • University Hospital Galway

    Galway

  • University Hospital Limerick

    Limerick

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Mexico3 sites
  • Fray Juan de San Miguel

    Michoacán

  • Clinica Hospital San Jose de Navojoa SA de CV

    Sonora

  • Hospital Star Médica Merida

    Yucatán

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Belarus2 sites
  • City Clinical Emergency Hospital

    Minsk

  • RSPC

    Minsk

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Estonia2 sites
  • East-Tallinn Central Hospital

    Tallinn

  • North Estonia Medical Center

    Tallinn

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Lebanon2 sites
  • Hopital Abou Jaoudé

    Beirut

  • Labib Medical Center

    Sidon

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Lithuania2 sites
  • LSMU Kauno Klinikos

    Kaunas

  • Klaipeda Seamen's Hospital

    Klaipėda

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North Macedonia2 sites
  • City General Hospital 8th September Skopje

    Skopje

  • University Clinic of Cardiology

    Skopje

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Saudi Arabia2 sites
  • Prince Abdullah Bin Abdulaziz Cardiac Center

    North Region Arar KSA

  • Dallah Hospital

    Riyadh

Other trials in Saudi Arabia

Bangladesh1 site
  • National Heart Foundation Hospital and Research Institute

    Dhākuli

Other trials in Bangladesh

Iceland1 site
  • Landspitali National University hospital

    Reykjavik

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Jordan1 site
  • Jordan Hospital

    Amman

Other trials in Jordan

Kuwait1 site
  • Sabah Al Ahmad Cardiac Center

    Kuwait City

Other trials in Kuwait

Oman1 site
  • Muscat Private Hospital

    Muscat

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Portugal1 site
  • Hospital Santa María

    Lisbon

Other trials in Portugal

Slovakia1 site
  • Stredodlovensky Ustav Srdcovych A Cievnych Chorob

    Banská Bystrica

Other trials in Slovakia

Uzbekistan1 site
  • Republic Specialized Center of Surgery

    Tashkent

Other trials in Uzbekistan

Vietnam1 site
  • Thong Nhat Hospital

    Hò Chi Minh City

Other trials in Vietnam

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.

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.

  1. 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)
  1. success endpoints

    Procedural success and Device success

    Measured: 3 months and 1 year

  2. 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

  3. 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.

  1. First posted11 Jul 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionJun 2020 (estimated)
  4. Study completionJun 2020 (estimated)

Resources

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
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 38045434
  • Kobo 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 35876646
  • Cimci 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

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.

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