Phase
Condition
Coronary Artery Disease
Cardiac Disease
Thrombosis
Treatment
12-month DAPT (Standard of care)
Xience: Sirolimus-eluting stent
Xience: Everolimus-eluting stent
Clinical Study ID
Ages 18-95 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age >18 - < 95 years;
Presence of one or more coronary artery stenosis of 50% or more in a native coronaryartery or in a saphenous venous or arterial bypass conduit suitable for coronarystent implantation. The vessel should have a reference vessel diameter of at least 2.00 mm (no limitation on the number of treated lesions, vessels, or lesion length);
Able to provide informed consent and willing to participate in the trial.
Exclusion
Exclusion Criteria:
Known intolerance to acetylsalicylic acid, P2Y12 inhibitors (clopidogrel, prasugrel,or ticagrelor), sirolimus, everolimus, or chromium-cobalt.;
Known severe hepatic impairment Child-Pug stage C;
Prior PCI (not related to the study) performed in the last 45 days;
Planned non-cardiac surgery during the first month after PCI, unless dualantiplatelet therapy is maintained throughout the peri-surgical period;
Planned coronary artery bypass graft (CABG) or any other cardiac surgery (valvularfor instance) following index PCI;
Active major bleeding or major surgery within the last 30 days;
Known stroke (any type) within the 30 days prior to the randomization;
Women of childbearing potential being defined as woman from the onset ofmenstruation (menarche) until they become postmenopausal, unless they arepermanently sterile. A postmenopausal state is clarified as having no menstrualperiods for 12 consecutive months without any other medical cause. Women who haveundergone permanent sterilization methods, including hysterectomy, bilateralsalpingectomy, and bilateral oophorectomy, can be enrolled in the study
Currently participating in another randomized controlled trial and not yet at itsprimary endpoint;
Life expectancy less than one year due to non-cardiovascular comorbidity.
Study Design
Connect with a study center
Olv Aalst
Aalst,
BelgiumActive - Recruiting
IMELDA
Bonheiden,
BelgiumActive - Recruiting
CHU Marie Curie
Charleroi,
BelgiumActive - Recruiting
ZOL GENK
Genk,
BelgiumActive - Recruiting
CHC Montlégia
Liège,
BelgiumActive - Recruiting
Hospital de La Citadelle
Liège,
BelgiumActive - Recruiting
Chu Ambroise Pare
Mons,
BelgiumActive - Recruiting
Az Delta
Roeselare,
BelgiumActive - Recruiting
Az Turnhout
Turnhout,
BelgiumActive - Recruiting
Chu Lille
Lille,
FranceActive - Recruiting
Icps Massy
Massy,
FranceActive - Recruiting
Ipcs Quincy
Quincy-sous-Sénart,
FranceActive - Recruiting
Chu Toulouse
Toulouse,
FranceActive - Recruiting
Complejo Hospitalario Universitario A Coruña
A Coruña,
SpainActive - Recruiting
Complejo Hospitalario Torrecárdenas
Almería,
SpainActive - Recruiting
Hospital Clínic de Barcelona
Barcelona,
SpainActive - Recruiting
Hospital Germans Trias I Pujol
Barcelona,
SpainActive - Recruiting
Hospital Universitario Vall D'Hebrón
Barcelona,
SpainActive - Recruiting
Hospital Universitario de Bellvitge
Barcelona,
SpainActive - Recruiting
Hospital de La Santa Creu I Sant Pau
Barcelona,
SpainActive - Recruiting
Hospital San Pedro de Alcantara
Cáceres,
SpainActive - Recruiting
Hospital Universitario Juan Ramón Jiménez
Huelva,
SpainActive - Recruiting
Hospital Universitario Jerez de La Frontera
Jerez De La Frontera,
SpainActive - Recruiting
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria,
SpainActive - Recruiting
Hospital Universitario de León
León,
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid,
SpainActive - Recruiting
Hospital Universitario Puerta de Hierro
Madrid,
SpainActive - Recruiting
Hospital Clínico Universitario Virgen de La Arrixaca
Murcia,
SpainActive - Recruiting
Hospital Universitario Regional de Málaga
Málaga,
SpainActive - Recruiting
Hospital Universitario Virgen de La Victoria
Málaga,
SpainActive - Recruiting
Hospital Universitari Son Espases
Palma De Mallorca,
SpainActive - Recruiting
Hospital de Navarra
Pamplona,
SpainActive - Recruiting
Hospital Universitario Marqués de Valdecilla
Santander,
SpainActive - Recruiting
Hospital Clínico Universitario de Santiago
Santiago De Compostela,
SpainActive - Recruiting
Hospital Clínico Universitario de Valencia
Valencia,
SpainActive - Recruiting
Hospital Universitario Y Politécnico La Fe
Valencia,
SpainActive - Recruiting
Hospital Clínico Universitario de Valladolid
Valladolid,
SpainActive - Recruiting
Hospital Álvaro Cunqueiro
Vigo,
SpainActive - Recruiting
Hospital Universitario Miguel Servet
Zaragoza,
SpainActive - Recruiting
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