Study Details
Study Design:
National, prospective, observational, multi-centre, investigator-initiated registry.
Schematic :
- Screening/Eligibility → ‘Real-world’ patient including, but not limited to, stable and unstable patients with single or multi-vessel disease and/or complex lesions.
- Planned follow-up → 12 months
- Endpoints
- Primary endpoint:
- TLF at 12 months follow-up. TLF is defined as a composite endpoint comprising cardiac death, target vessel myocardial infarction (both Q-wave and non–Q-wave), or clinically driven TLR performed via either percutaneous or surgical methods.
- Secondary endpoints (12 months):
- Overall stent thrombosis.
- All deaths (cardiac, vascular and non-cardiovascular).
- Any myocardial infarction (Q wave and non-Q wave MI).
- Any repeat revascularization (target lesion and target vessel revascularization).
- TVF: a composite endpoint of cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization.
- MACE: a composite endpoint of cardiac death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or repeat TLR (clinically driven/clinically indicated) by percutaneous or surgical methods.
- Primary endpoint:
Abbreviation: TLF: Target Lesion Failure, TLR: Target Lesion Revascularization, TVF: Target Vessel Failure, MACE: Major adverse cardiac events