Ischemic Heart Disease
Conditions
Brief summary
The purpose of the study is 1\> to compare neointimal stent coverage after OCT-guided vs. Angio-guided PCI, 2\> to compare neointimal stent coverage at 3 months after EES vs BES implantation, 3\> to determine the duration of dual antiplatelet therapy by OCT measurement at 3 months
Interventions
DEVICEAngio-guided PCI with EES or BES
Angio-guided intervention
DEVICEOCT-guided PCI with EES or BES
OCT-guided intervention
DEVICEPCI with BES under angio-guide or OCT guide
biolimus A9-eluting stent.
DEVICEPCI with EES under angio-guide or OCT guide
everolimus eluting stent.
DRUGKeep DAPT
maintain DAPT for 12 months according to level of uncovered strut (\>6%) at 3months OCT follow up after stent implantation.
DRUGDiscontinue DAPT
discontinue DAPT according to level of uncovered strut (≤6%) at 3months OCT follow up after stent implantation.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥ 20 years old * Patients with ischemic heart disease who are considered for coronary revascularization with stent implantation. * Significant coronary de novo lesion (stenosis \> 70% by quantitative angiographic analysis) treated by single DES ≤ 25mm * Reference vessel diameter of 2.5 to 3.5 mm by operator assessment
Exclusion criteria
* Complex lesion morphologies such as aorta-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, and restenosis * Reference vessel diameter \< 2.5 mm or \> 4.0mm * Heavy calcified lesions (definite calcified lesions on angiogram) * Primary PCI for STEMI * Contraindication to anti-platelet agents * Treated with any DES within 3 months at other vessel * Creatinine level ≥ 2.0 mg/dL or ESRD * Severe hepatic dysfunction (3 times normal reference values) * Pregnant women or women with potential childbearing * Life expectancy \< 1 year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage of neointimal coverage at 3 month-OCT after stent implantation | at 3 month-OCT after stent implantation |
Secondary
| Measure | Time frame |
|---|---|
| The occurrence of the composite of cardiac death, MI, definite or probable stent thrombosis, and TIMI-defined major bleeding for 12 months | 12 months after PCI |
| percentage of malposition strut at 3 month-OCT after stent implantation | 3 months after PCI |
| The occurrence of the composite of All cause death, spontaneous MI, Target vessel revascularization and stroke. | 12 months after PCI |
| Target vessel revascularization | 12 months after PCI |
| TIMI-defined major bleeding for 12 months | 12 months after PCI |
Countries
South Korea
Outcome results
None listed