coronary stenosis narrowing of the arteries which supply the heart with blood
Conditions
Interventions
The Orsiro or Xience stent is chosen at random, which makes this an
interventional study.
Coronary Artery Disease
Drug eluting stent
Percutaneous Coronary Intervention
Randomized Controlled Trial
Sponsors
Biotronik
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1.Subject is *18 years or the minimum age required for legal adult consent in the country of enrollment. 2.Subject is an acceptable candidate for PCI. 3.Subject is an acceptable candidate for CABG. 4.Subject has clinical evidence of ischemic heart disease, stable or unstable angina pectoris or documented silent ischemia. 5.Subject is eligible for dual anti-platelet therapy treatment with aspirin plus either, clopidogrel, prasugrel, ticagrelor or ticlopidine. 6.Subject has provided written informed consent. 7.Subject is willing to comply with study follow-up requirements. stents.
Exclusion criteria
Exclusion criteria: 1.Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure. 2.Subject is hemodynamically unstable. 3.Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study. 4.Subject has a known allergy to contrast medium that cannot be adequately pre-medicated, or any known allergy to thienopyridine, aspirin, both heparin and bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten and nickel), acrylic, fluoropolymers, silicon carbide, PLLA, sirolimus or everolimus. 5.Revascularization of any target vessel within 9 months prior to the index procedure or previous PCI of any non-target vessel within 30 days prior to the index procedure. 6.Planned treatment of a lesion not meeting angiographic inclusion and exclusion criteria during the index procedure or after the index procedure. 7.Planned surgery within 6 months of index procedure unless dual antiplatelet therapy can be maintained throughout the peri-surgical period. 8.History of a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure. 9.Subjects with active bleeding disorders, active coagulopathy, or any other reason, who are ineligible for DAPT. 10.Subject will refuse blood transfusions. 11.Subject has documented left ventricular ejection fraction (LVEF) 2.5 mg/dL or 221 *mol/L determined within 7 days prior to the index procedure). 14.Subject has leukopenia (i.e. 700,000 platelet/mm3). 15.Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are permitted), or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus is permitted). 16.Subject is receiving chronic anticoagulation (e.g. coumadin, dabigatran, apixaban, rivaroxaban or any other agent). 17.Subject has life expectancy of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for the main randomized controlled trial (RCT) is Target lesion failure (TLF) rate at 12 months post*index procedure. TLF is defined as all cardiac death, target vessel Q-wave or non*Q-wave myocardial infarction (MI), or clinically driven target lesion revascularization (TLR). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the following measures: 1. Device success, defined as attainment of | — |
Countries
The Netherlands
Outcome results
None listed