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)

Not Applicable

Completed

• Conditions: Ischemic Heart Disease
• Interventions: Device: PCI with BES under angio-guide or OCT guide; Device: PCI with EES under angio-guide or OCT guide; Drug: Discontinue DAPT; Drug: Keep DAPT; Device: OCT-guided PCI with EES or BES; Device: Angio-guided PCI with EES or BES

• Registration Number: NCT01752894
• Lead Sponsor: Yonsei University

Brief 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-12-14
• Study First Submitted QC: 2012-12-14
• Study First Posted: 2012-12-19
• Study Start: 2013-01-02
• Primary Completion: 2017-04-11
• Study Completion: 2017-04-11
• Status Verified: 2018-03
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 776

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BES	PCI with BES under angio-guide or OCT guide	-
EES	PCI with EES under angio-guide or OCT guide	-
Discontinue Dual antiplatelet therapy (DAPT)	Discontinue DAPT	Study subjects will be allocated into this arm with non-randomization method
Keep dual antiplatelet therapy (DAPT)	Keep DAPT	Study subjects will be allocated into this arm with non-randomization method
OCT-guided PCI	OCT-guided PCI with EES or BES	-
Angio guided PCI	Angio-guided PCI with EES or BES	-

Primary Outcome Measures

Name	Time	Method
percentage of neointimal coverage at 3 month-OCT after stent implantation	at 3 month-OCT after stent implantation

Secondary Outcome Measures

Name	Time	Method
TIMI-defined major bleeding for 12 months	12 months after PCI
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
percentage of malposition strut at 3 month-OCT after stent implantation	3 months after PCI
The occurrence of the composite of All cause death, spontaneous MI, Target vessel revascularization and stroke.	12 months after PCI
Target vessel revascularization	12 months after PCI

Trial Locations

Locations (1)

Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of