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

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Promus Element everolimus eluting coronary stent
* Device: Xience Prime everolimus eluting coronary stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: P-E group<br>Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime | Device: Promus Element everolimus eluting coronary stent<br>* Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime<br>|
| Active Comparator: X-P group<br>Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime | Device: Xience Prime everolimus eluting coronary stent<br>* Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the ratio of the malapposed strut | The ratio of the malapposed strut, on an immediate OCT after nominal stent pressure and at a final post-procedure between two different DES; ANCHOR-I | Participants will be followed from first OCT invervention to 3month OCT following intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of stent malapposition |  | 3months OCT following intervention | 
| Neointimal coverage(ANCHOR II) |  | 3 month-OCT after stent implantation | 
| Incidence of plaque prolapse |  | final postprocedural OCT | 
| Evaluation of stent expansion |  | an immediate and post-procedural OCT | 
| Stent malapposition |  | on 3 month OCT intervention |