Stenosis of one or more of the vessels of the heart/ Cardio vascular stenosis
Conditions
Interventions
1430 patients will be enrolled to receive treatment with either the study
device (SUPRAFLEX) or a control device (XIENCE), in a 1:1 randomization (715
SUPRAFLEX and 715 XIENCE).
Sponsors
Cardialysis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients >=18 years; 2. Presence of one or more coronary artery stenoses of >=50% in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. 3. The vessel should have a reference vessel diameter ranging from >=2.25 mm to
Exclusion criteria
Exclusion criteria: 1. Known pregnancy or breastfeeding at time of randomization; 2. Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor; 3. Any PCI treatment within 6 months (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for this trial is a non-inferiority comparison of the device-oriented composite endpoint Target Lesion Failure of the SUPRAFLEX group to the XIENCE group at 12 months post-procedure. TLF (DoCE) is a composite of clinical endpoint of cardiac death, target vessel myocardial infarction (TV-MI) and clinically-indicated target lesion revascularization (TLR). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Composite Endpoints a. Patient Oriented Composite Endpoint (PoCE) defined as all-cause death, any MI, and any revascularization b. Target Vessel Failure (TVF) defined as cardiac death, TV MI*, and clinically indicated Target Vessel Revascularization c. TLF (DoCE) defined as cardiac death, TV MI* and clinically-indicated Target Lesion Revascularization (for all follow-up/visits other than 12 months) 2. Mortality a. All death b. Cardiac death c. Non-cardiac death (vascular and non-cardiovascular) 3. Myocardial Infarction* a. All MI b.Target Vessel MI c. Non-Target Vessel MI 4. Revascularization a. Any revascularization b.Target Lesion revascularization (TLR) (any, clinically-indicated TLR, non-clinically indicated TLR) c.Target Vessel revascularization (TVR) (any, clinically-indicated TVR, non-clinically indicated TVR) d.Non-Target Vessel revascularization 5. Stent thrombosis rates according to ARC classification | — |
Countries
Netherlands
Outcome results
None listed