Stenosis of one or more of the vessels of the heart/ Cardio vascular stenosis
Conditions
Interventions
Enrollment of 1400 patients with 700 MISTENT and 700 XIENCE, Approximately 17
sites in Europe will participate.
Sponsors
Cardialysis BV
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 2.5 mm to 3.5 mm (no limitation on the number of treated lesions, vessels, or lesion length);
Exclusion criteria
Exclusion criteria: 1. Known pregnancy at time of randomization. Female who is breastfeeding at time of randomization; 2. Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor; 3. Concurrent medical condition with a life expectancy of less than 12 months; 4. The patient is unwilling/ not able to return for outpatient clinic at 1 months and 12 months follow-up; 5. Currently participating in another trial and not yet at its primary endpoint.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for this trial is a non-inferiority comparison of a device-oriented composite endpoint (DOCE) or TLF of the MISTENT group to the XIENCE group at 12 months post-procedure. TLF is a composite of clinical endpoint of cardiac death, myocardial infarction (MI, WHO Extended Definition) not clearly attributable to a nontarget vessel and clinically-indicated target lesion revascularization (TLR). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints (evaluated at each follow-up visit/contact) 1. Composite Endpoints • POCE defined as all-cause death, any MI, or any revascularization • MACE defined as all-cause death, any MI, or any TVR • TVF defined as cardiac death, TV MI, or clinically indicated TVR • DOCE/TLF defined as cardiac death, TV MI or clinically-indicated TLR (for all follow-up/visits other than 12 months) 2. Mortality • All death • Cardiac death • Non-cardiac death (vascular and non-cardiovascular) 3. Myocardial Infarction • All MI • TV-MI • Non-TV-MI 4. Revascularization • Target Lesion revascularization (TLR) (any, clinically-indicated TLR, non-clinically indicated TLR) • Target Vessel revascularization (TVR) (any, clinically-indicated TVR, non-clinically indicated TVR) • Non-TV revascularization • Any revascularization 5. Stent thrombosis rates according to ARC classification • ST - Early (Acute, Sub-acute), Late, Very Late. • ST - Definite, Probable, Possible • ST - Definite/Probable | — |
Countries
Netherlands
Outcome results
None listed