This is an investigator initiated randomized trial, performed under the auspices of the Spanish Society of Cardiology. It is a multicenter, international, parallel, randomized 1:1 (amphilimus-eluting stents vs zotarolimus-eluting stents) clinical trial performed exclusively in patients with diabetes mellitus. The study has an "all-comers diabetics" design. The primary-endpoint is target lesion failure at 1-year follow-up (non-inferiority design) and the co-primary end-point is target lesion failure at 2-years follow-up (superiority-design).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,164
Cre8 Evo coronary stent system (CID, Saluggia, Italy)
Resolute Onyx coronary stent system (Medtronic, Minneapolis, Minnesota, US)
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital General Universitario de Alicante
Alicante, Spain
Target lesion failure at 1-year follow-up
A composite of cardiac death, any myocardial infarction (not clearly attributable to a non-target vessel), or clinically indicated target-lesion revascularization at 12-months follow-up.
Time frame: 12 months
Target lesion failure at 2-years follow-up
A composite of cardiac death, any myocardial infarction (not clearly attributable to a non-target vessel), or clinically indicated target-lesion revascularization at 24-months follow-up.
Time frame: 24 months
Cardiac death
Time frame: 12 and 24 months
Target vessel myocardial infarction
Time frame: 12 and 24 months
Target vessel revascularization
Time frame: 12 and 24 months
Target lesion revascularization
Time frame: 12 and 24 months
Stent thrombosis
Academic Research Consortium definitions
Time frame: 12 and 24 months
Non-target lesion revascularization
Time frame: 12 and 24 months
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Hospital San Juan
Alicante, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Vall d'Hebrón
Barcelona, Spain
Hospital Reina Sofía
Córdoba, Spain
Hospital Juan Ramón Jiménez
Huelva, Spain
Hospital Doctor Negrín
Las Palmas de Gran Canaria, Spain
...and 13 more locations