Coronary Artery Disease
Conditions
Brief summary
This study is designed as a prospective, randomized, multi-center trial to demonstrate an inequality between IVUS-guided versus angiography-guided implantation of everolimus-eluting stents(EES) at long lesions(\> 28 mm) in clinical outcomes at 12 months as a primary objective and safety of 6- month dual antiplatelet therapy following EES implantation in comparison with a 12-month dual antiplatelet therapy.
Detailed description
The primary purpose of this study is to investigate the impact of IVUS guidance on the clinical outcomes after implantation of DES at long lesions \> 28 mm.
Interventions
PROCEDUREPCI with IVUS guidance
Patients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1.
PROCEDUREPCI without IVUS guidance
Patients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Age 20 years old or older * Patients with typical chest pain or evidences of myocardial ischemia (e.g., stable, unstable angina, silent ischemia and positive functional study or reversible changes in the electrocardiogram (ECG) consistent with ischemia * Non-emergent conditions * Patients with signed informed consent * Stent length ≥28 mm by angiography estimation * Significant coronary artery stenosis (\> 50% by visual estimate) considered for coronary revascularization with stent implantation * Reference vessel diameter of 2.5 to 4.0 mm by operator assessment
Exclusion criteria
* Acute ST elevation myocardial infarction within 48 hours * Contraindication to anti-platelet agents & bleeding history within prior 3 months * Known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Zotarolimus or other -limus group * Prior history of the following presentations * Cerebral vascular accident (not including transient ischemic attack) * Peripheral artery occlusive diseases * Thromboembolic disease * Stent thrombosis * Age \> 80 years old * Severe hepatic dysfunction (3 times normal reference values) * Significant renal dysfunction (Serum creatinine \> 2.0 mg/dl) * Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis * Cardiogenic shock * LVEF \< 40% * Pregnant women or women with potential childbearing * Life expectancy \< 1 year * Left main disease requiring PCI * Bifurcation lesion with 2-stent technique * Chronic total occlusion * Presence of previously implanted DES within 6-month * In-stent restenosis lesion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac event, a composite of cardiac death, target lesion related MI, target lesion revascularization following randomly assigned PCI procedures with versus without IVUS guidance | 12 months after the index procedure | Major adverse cardiac event, a composite of cardiac death, target lesion related MI, target lesion revascularization following randomly assigned PCI procedures with versus without IVUS guidance |
Countries
South Korea
Outcome results
None listed