Randomized Controlled Study of the Traditional Percutaneous Coronary Intervention and Intervention Using Optical Coherence Tomography of Incomplete Stent Adhesion and Extent of the Formation of Neointima by Resolute Zotarolimus-eluting Stent Insertion

Study Overview
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Brief Summary
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Optical coherence tomography (OCT) after the stent procedure to improve the adhesion and expansion, or incomplete uncovered struts attached to the main track. OCT in clinical areas by improving the parameters of the best stent will be useful. However, for better results for optical coherence tomography in percutaneous interventions have little useful data on the role. Randomized controlled study of the traditional percutaneous coronary intervention and intervention using optical coherence tomography.

Conditions
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Coronary Artery Disease, Stable Angina, Unstable Angina

Intervention / Treatment
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* Procedure: percutaneous coronary intervention
* Procedure: OCT-guided percutaneous coronary intervention
* Procedure: percutaneous coronary intervention
* Procedure: OCT-guided percutaneous coronary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Single lesion in a Single vessel Reference vessel diameter 2.5 - 3.5 mm Lesion length ≤ 34 mm and ≤ 34 mm stent length Stable angina requiring revascularization, patients with unstable angina The patient has no difficulty to enforce the follow-up angiography Patient is ≥ 20 years old Exclusion Criteria: Lesions with graft vessel, thrombosis, restenosis, and bifurcation requiring 2 stents Reference vessel diameter < 2.5 mm or > 4.0mm 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) Patients with LVEF < 30% Life expectancy 1 year Lesions with CTO or left main Target vessel of ST-elevation MI Lesions requiring overlapped stenting or more than 2 DES in each vessel Heavy calcified lesions (definite calcified lesions on angiogram) Far distal or tortuous lesions having difficulties in OCT evaluation or follow-up OCT Pregnant women or women with potential childbearing

Ages Eligible for Study
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Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DM, angio group<br> | Procedure: percutaneous coronary intervention<br>* the traditional percutaneous coronary intervention by Resolute zotarolimus-eluting stent insertion<br>|
| Experimental: DM, OCT group<br> | Procedure: OCT-guided percutaneous coronary intervention<br>* the percutaneous coronary intervention using optical coherence tomography by Resolute zotarolimus-eluting stent insertion<br>|
| Active Comparator: non DM, angio group<br> | Procedure: percutaneous coronary intervention<br>* the traditional percutaneous coronary intervention by Resolute zotarolimus-eluting stent insertion<br>|
| Experimental: non DM, OCT group<br> | Procedure: OCT-guided percutaneous coronary intervention<br>* the percutaneous coronary intervention using optical coherence tomography by Resolute zotarolimus-eluting stent insertion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ratio of the stent strut |  | Angiographic follow-up with OCT at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resolute zotarolumus-eluting stent, optical coherence tomography