arteriosclerose hardening of the arteries
Conditions
Interventions
None listed
Sponsors
Medisch Spectrum Twente
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Minimum age of 18 years * Coronary artery disease and lesion(s) eligable for treatment with drug eluting stents according to clinical guidelines and/or the operators* judgement * Patient is willing and able to cooperate with study procedures and required follow-up visits; and patient has been informed and agrees on the participation by signing an EC approved written informed consent.
Exclusion criteria
Exclusion criteria: Participation in another randomized drug or device study before reaching primary endpoint * Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period * Intolerance to a P2Y12 receptor antagonist that results in the patient*s inability to adhere to dual-antiplatelet therapy, or intolerance to aspirin, heparin, or components of the two DES examined * Known pregnancy * Life expectancy of less than 1 year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Target vessel failure (TVF) at 12 months Components of the primary endpoint in hierarchical order: o Cardiac death. All deaths are considered cardiac, unless an unequivocal non-cardiac cause can be established. o Target vessel related MI that is Q-wave or non-Q-wave myocardial infarction that can be related to the target vessel or cannot be related to another vessel. o Clinically driven repeated target vessel revascularization by means of CABG or PCI | — |
Secondary
| Measure | Time frame |
|---|---|
| * Clinical endpoints at 1,12, 24,36,48,60 month follow-up (with the exception of TVF at 1 year which is the primary endpoint, as described above): o Death o Any myocardial infarction o Any revascularisation by means of PCI or Coronary Artery Bypass Grafting (CABG). o Target vessel related death o Target vessel related myocardial infarction (MI) o Clinically indicated repeated target vessel revascularization (TVR) o Clinically indicated repeated target lesion revascularization (TLR) o New onset of angina pectoris: o Stent thrombosis (Definite, Probable, and Possible; ARC definition): * Composite endpoint at one and three month and 12, 24,36,48,60 year follow-up (except TVF at one year follow-up which is already the primary endpoint) : o Target vessel failure (TVF) as defined above. o Target Lesion Failure (TLF) o Major Adverse Cardiac Events (MACE), patient oriented compositie endpoint (hierarchical order) o MACE, device/lesion oriented * Angiographic endpoints in entire population at final angiographic assessment : * A substudy will include angiographic endpoints in subpopulation of patients referred for angiographic re-evaluation * In subgroups of patients with clinically indicated Intravascular ultrasound (IVUS) and/or Optical Coherence Tomography (OCT) endpointswill be assessed | — |
Countries
Netherlands
Outcome results
None listed