Percutaneous Coronary Intervention (PCI) Drug-eluting stent Coronary atherosclerosis
Conditions
Interventions
Intervention will involve randomization of the type of DES (Promus Element versus Resolute Integrity) used in study population. Duration of randomization will be two years.
Sponsors
Medisch Spectrum Twente
Eligibility
Inclusion criteria
Inclusion criteria: 1. Minimum age of 18 years; 2. Coronary artery disease and lesion(s) eligable for treatment with drug eluting stents according to clinical guidelines and/or the operators’ judgement; 3. 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: 1. Participation in another randomized drug or device study before reaching primary endpoint; 2. Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period; 3. 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; 4. Known pregnancy; 5. Life expectancy of less than 1 year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter/endpoint: Target vessel failure (TVF) at 12 months (according to ARC definitions). Components of the primary endpoint in hierarchical order: 1. Cardiac death. All deaths are considered cardiac, unless an unequivocal non-cardiac cause can be established; 2. 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; 3. Clinically driven repeated target vessel revascularization by means of CABG or PCI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical endpoints at 1, 12, 24 month follow-up (with the exception of TVF at 1 year which is the primary endpoint, as described above): 1. Death; A. Cardiac; B. Vascular; C. Other causes; D. All-cause mortality; 2. Any myocardial infarction; A. Q-wave; B. Non Q-wave; 3. Any revascularisation by means of PCI or Coronary Artery Bypass Grafting (CABG); 4. Target vessel related death; 5. Target vessel related myocardial infarction (MI); A. Q-wave myocardial infarction; B. Non Q-wave myocardial infarction; 6. Clinically indicated repeated target vessel revascularization (TVR); A. CABG; B. PCI; 7. Clinically indicated repeated target lesion revascularization (TLR); A. CABG; B. PCI; 8. New onset of angina pectoris: A. Related to the target vessel; B. Related to another vessel; C. Unspecified; 9. Stent thrombosis (Definite, Probable, and Possible; ARC definition): A. Early; B. Subacute; C. Late; D. Very late; 10. Composite endpoint at one month and 1 and 2 year follow-up (except TVF at one year follow-up which is already the primary endpoint); 11. Target vessel failure (TVF) as defined above; A. Target Lesion Failure (TLF); B. Cardiac death; 12. Any myocardial infarction (not clearly attributable to a nontarget vessel; A. Clinically driven TLR; 13. Major Adverse Cardiac Events (MACE), patient oriented compositie endpoint (hierarchical order); A. All cause mortality; B. Any MI (including non-target vessel territory); C. Any repeat revascularization (target and non-target vessels) by means of CABG or PCI oMACE, device/lesion oriented ( hierarchical order); D. All cause mortality; E. Any MI (including non-target vessel territory); F. Emergent coronary-artery bypass surgery, or repeat clinically indicated target-lesion percutaneous or surgical revascularization. Angiographic endpoints in entire population at final angiographic assessment: 1. At final angiographic assessment the stented segment will be analyzed and the minimum lumen d | — |
Contacts
Public ContactH. Verheij
Medisch Spectrum Twente Haaksbergerstraat 55
Outcome results
None listed