Arterio sclerose hardening of the arteries
Conditions
Interventions
None listed
Sponsors
Medisch Spectrum Twente
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Indication for PCI with DES implantation based on NVVC/ESC guidelines and/or clinical decision of interventional cardiologist * Age >= 18 years and mentally capable to give an informed consent * Signed informed consent
Exclusion criteria
Exclusion criteria: * Patients with ST-elevation myocardial infarction (STEMI) or an ST-elevation myocardial infarction equivalent requiring primary PCI or rescue PCI * Patients in whom the revascularization procedure is planed to be performed in a staged approach * Renal failure requiring haemodialysis * Patient is currently participating in an investigational drug or device study that has been not completed * Life expectancy less than 1 year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Target vessel failure (TVF) at 12 months (according to ARC definitions) Components of the primary endpoint in hierarchical order: * Target vessel related death or cardiac death that cannot be clearly attributed to a vessel other than the target vessel. All deaths are considered cardiac, unless an unequivocal noncardiac cause can be established. * Target vessel related MI (n,%), 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. * Clinically driven repeated target vessel revascularization by means of CABG or PCI (n,%) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Clinical endpoints at one and three month and 1,2,3,5 year 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 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 month and 1,2,3,5 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 Major Adverse Cardiac Events (MACE), patient oriented 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 and in subpopulation of these patients who will require re-intervention e.g. clinically indicated angiographic re-evaluation. • In subgroup of patients with clinically indicated Intravascular ultrasound (IVUS) endpoints will be assessed | — |
Countries
Netherlands
Outcome results
None listed