Angina Pectoris
Conditions
Interventions
Niet van toepassing
Sponsors
ONLUS
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I,II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II-III) OR patients with documented silent ischemia, all treated with a second generation drug eluting stent, according to the usual practice of the centre. 2. Presence of one or more de novo stenosis equal or greater than 70% in a native coronary artery, treated with a second generation drug eluting stent 3. Patient is > 18 years of age (or minimum age as required by local regulations). 4. The patient has consented to participate by signing the *Patient Informed Consent Form*. 5. The patient is willing and able to cooperate with study procedures and required follow up visits. 6. Any type of lesion or number of lesion can be included in this trial unless specifically detailed in the exclusion criteria. 7. At least one second generation DES implanted in the target lesion in the last 24 hours. 8. No other DES implanted before the target procedure 9. No BMS implanted in the 3 months before the target procedure
Exclusion criteria
Exclusion criteria: 1. Patients treated for lesions in venous or arterial grafts. 2. Patients treated for in-stent restenosis. 3. Patients treated for Unprotected Left Main lesions. 4. ST elevation myocardial infarction in the 48 hours prior to the procedure. 5. Non ST elevation myocardial infarction in the previous six months. 6. Patients with LVEF2mg or mg or 180 mmol/l) 10. Contraindication to the use of thienopyridines and/or ASA: a. History of drug allergy to thienopyridine derivatives or ASA; b. History of clinically significant or persistent thrombocytopenia or neutropenia 11. Active bleeding or significant risk of bleeding, such as elderly patients receiving fibrinolytic therapy and other potent antithrombotic agents, severe hepatic insufficiency, current peptic ulceration., proliferative diabetic retinopathy. 12. Uncontrolled hypertension. 13. Current medical condition with a life expectancy of less than 24 months. 14. The subject is participating in another device or drug study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrolment in this trial. 15. Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the composite of cardiac death, myocardial infarction, stroke, definite or probable stent thrombosis or BARC type 2, 3 or 5 bleeding at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| • the composite of cardiac death, myocardial infarction, stroke, definite or probable stent thrombosis or BARC type 2, 3 or 5 bleeding at 24 months • cumulative occurrence of the individual components of the primary endpoint at 12 and 24 months • Myocardial infarction at 30 days, 6, 12 and 24 months • Urgent target vessel revascularization (cardiac bypass surgery, or repeat PTCA) at 30 days, 6, 12 and 24 months • Possible stent thrombosis rate between 6 and 24 months • Economic evaluation and comparison between the two arms at 24 months • All bleeding events (major and minor) • All cause mortality at 6, 12 and 24 months | — |
Countries
Netherlands
Outcome results
None listed