DETErmination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of The Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus-eluting Stents(EES) Versus Biolimus A9-eluting Stents(BES)

• Status: Completed
• Trial end date: 2017-04-11
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Everolimus

Criteria

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