Ischemic Heart Disease Clinical Trial
— DETECT-OCTVerified date | March 2018 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 776 |
Est. completion date | April 11, 2017 |
Est. primary completion date | April 11, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | percentage of neointimal coverage at 3 month-OCT after stent implantation | at 3 month-OCT after stent implantation | ||
Secondary | 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 | ||
Secondary | percentage of malposition strut at 3 month-OCT after stent implantation | 3 months after PCI | ||
Secondary | The occurrence of the composite of All cause death, spontaneous MI, Target vessel revascularization and stroke. | 12 months after PCI | ||
Secondary | Target vessel revascularization | 12 months after PCI | ||
Secondary | TIMI-defined major bleeding for 12 months | 12 months after PCI |
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