Assessment of Stent Malapposition and Neointimal Coverage on Optical coHerence Tomography at Post-procedure and 3 Months After Platinum Chromium Alloy Of the Element™ Stent Implantation

2-phased Randomized Comparison Between PromusTMElementTM Versus Xience PRIME® Stent

The purpose of this study is to compare the degree of stent malapposition on an immediate optical coherence tomography (OCT) after nominal stent pressure and at a final post-procedure OCT (ANCHOR-I) and the neointimal coverage on 3-months OCT following the intervention with the randomly assigned two drug-eluting stents (DES), PromusTMElementTM stents versus Xience PRIME® stents.

Inclusion Criteria:

• Patient is ≥ 20 years old
• Significant coronary de novo lesion (> 70% by quantitative angiographic analysis) treated by single DES in each vessel.
• Patients with stable angina who are considered for coronary revascularization with stent implantation.
• Reference vessel diameter of 2.5 to 3.5 mm by operator assessment

Exclusion Criteria:

• Complex lesion morphologies such as aorto-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, and restenosis
• Reference vessel diameter < 2.5 mm or > 4.0mm and lesion length > 28 mm
• Heavy calcified lesions (definite calcified lesions on angiogram)
• Lesions requiring more than 2 DES in each vessel
• Acute coronary syndrome
• 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