The aim of this study is to evaluate safety and efficacy performances of CRE8 Drug Eluting Stent, in patients comparable to the everyday's clinical practice population, with a specific focus on diabetics, that will be part of a pre-specified study subgroup.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,191
Sirolimus formulated coronary eluting stent
Medizinische Universität Innsbruck
Innsbruck, Austria
Clinical composite endpoint: Cardiac death/Target vessel MI/Clinically indicated TLR
Time frame: 6 months
Clinical composite endpoints: - Cardiac death/Target vessel MI/Clinically indicated TLR - All death/All MI/All Repeat Revascularization
Time frame: At 30 days, 1 year and yearly up to 5 years
Stent thrombosis
Time frame: within 24 hours, 1 month, 6 months, 1 year and yearly up to 5 years
Angiographic in-stent and in-segment endpoints (in the first 100 patients included in the pre-specified diabetic subgroup).
reference vessel diameter; minimal lumen diameter; % diameter stenosis; binary restenosis; late lumen loss
Time frame: At 6 months
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