The primary objective of this study is to compare the performance of SUPRAFLEX to that of XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The patients will be followed through 3 years for major clinical events.
This is a prospective, randomized, 1:1 balanced, controlled, single-blind, multi-center study comparing clinical outcomes at 12 months between SUPRAFLEX and XIENCE in a "Real world, all comers" patient population (patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions). The objective is to compare the SUPRAFLEX SES with the XIENCE EES with respect to target lesion failure (TLF) at 12 months in a non-inferiority trial in a "real world" patient population. All patients will be (at minimum) contacted at 30 days, 6 months, and 12 months post procedure to assess clinical status and adverse events. The 30 day and 12 month will be a clinic visit. All patients will have annual contact through 3 years follow-up to assess clinical status and adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,435
Research Centre BG-004
Plovdiv, Bulgaria
Research Centre BG-001
Sofia, Bulgaria
Non inferiority comparison of a device oriented composite endpoint (DOCE) or Target Lesion Failure (TLF) of the SUPRAFLEX group to the XIENCE group
TLF is a composite of clinical endpoint of cardiac death, target vessel myocardial infarction (TV-MI) and clinically-indicated target lesion revascularization.
Time frame: 12 months post-procedure
Patient Oriented Composite Endpoint (PoCE) defined as the composite of all-cause death, any MI, and any revascularization
Time frame: 30 days, 6 months, 1 year, 2 years and 3 years
Target Vessel Failure (TVF) defined as cardiac death, TV MI, and clinically indicated target vessel revascularization
Time frame: 30 days, 6 months, 1 year, 2 years and 3 years
TLF (DoCE) defined as cardiac death, TV MI and clinically-indicated target lesion revascularization (for all follow-up/visits other than 12 months)
Time frame: 30 days, 6 months, 1 year, 2 years and 3 years
Mortality (All death, Cardiac death, and Non-cardiac death (vascular and non-cardiovascular)
Time frame: 30 days, 6 months, 1 year, 2 years and 3 years
Myocardial Infarction (All MI, Target Vessel MI, Non-Target Vessel MI)
Time frame: 30 days, 6 months, 1 year, 2 years and 3 years
Revascularization (Any revascularisation, TLR (clinically and non-clinically), TVR (clinically and non-clinically) and non-TVR.
Time frame: 30 days, 6 months, 1 year, 2 years and 3 years
Stent thrombosis rates according to ARC classification
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Research Centre HU-002
Budapest, Hungary
Research Centre HU-001
Szeged, Hungary
Research Centre IT-001
Milan, Italy
Research Centre NL-007
Amsterdam, Netherlands
Research Centre NL-008
Breda, Netherlands
Research Centre NL-009
Eindhoven, Netherlands
Research Centre NL-002
Leeuwarden, Netherlands
Research Centre NL-003
Rotterdam, Netherlands
...and 13 more locations
Time frame: 30 days, 6 months, 1 year, 2 years and 3 years