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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

776 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-02

Study Completion Date

2017-04-11

Brief Summary

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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

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Detailed Description

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Conditions

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Ischemic Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Angio guided PCI

Group Type ACTIVE_COMPARATOR

Angio-guided PCI with EES or BES

Intervention Type DEVICE

Angio-guided intervention

OCT-guided PCI

Group Type EXPERIMENTAL

OCT-guided PCI with EES or BES

Intervention Type DEVICE

OCT-guided intervention

BES

Group Type ACTIVE_COMPARATOR

PCI with BES under angio-guide or OCT guide

Intervention Type DEVICE

biolimus A9-eluting stent.

EES

Group Type EXPERIMENTAL

PCI with EES under angio-guide or OCT guide

Intervention Type DEVICE

everolimus eluting stent.

Keep dual antiplatelet therapy (DAPT)

Study subjects will be allocated into this arm with non-randomization method

Group Type ACTIVE_COMPARATOR

Keep DAPT

Intervention Type DRUG

maintain DAPT for 12 months according to level of uncovered strut (\>6%) at 3months OCT follow up after stent implantation.

Discontinue Dual antiplatelet therapy (DAPT)

Study subjects will be allocated into this arm with non-randomization method

Group Type ACTIVE_COMPARATOR

Discontinue DAPT

Intervention Type DRUG

discontinue DAPT according to level of uncovered strut (≤6%) at 3months OCT follow up after stent implantation.

Interventions

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Angio-guided PCI with EES or BES

Angio-guided intervention

Intervention Type DEVICE

OCT-guided PCI with EES or BES

OCT-guided intervention

Intervention Type DEVICE

PCI with BES under angio-guide or OCT guide

biolimus A9-eluting stent.

Intervention Type DEVICE

PCI with EES under angio-guide or OCT guide

everolimus eluting stent.

Intervention Type DEVICE

Keep DAPT

maintain DAPT for 12 months according to level of uncovered strut (\>6%) at 3months OCT follow up after stent implantation.

Intervention Type DRUG

Discontinue DAPT

discontinue DAPT according to level of uncovered strut (≤6%) at 3months OCT follow up after stent implantation.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No