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) (DETECT-OCT)

March 19, 2019 updated by: Yonsei University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

776

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OCT-guided PCI
Device: OCT-guided PCI with EES or BES
OCT-guided intervention
Active Comparator: Angio guided PCI
Device: Angio-guided PCI with EES or BES
Angio-guided intervention
Active Comparator: BES
Device: PCI with BES under angio-guide or OCT guide
biolimus A9-eluting stent.
Experimental: EES
Device: PCI with EES under angio-guide or OCT guide
everolimus eluting stent.
Active Comparator: Keep dual antiplatelet therapy (DAPT)
Study subjects will be allocated into this arm with non-randomization method
Drug: Keep DAPT
maintain DAPT for 12 months according to level of uncovered strut (>6%) at 3months OCT follow up after stent implantation.
Active Comparator: Discontinue Dual antiplatelet therapy (DAPT)
Study subjects will be allocated into this arm with non-randomization method
Drug: Discontinue DAPT
discontinue DAPT according to level of uncovered strut (≤6%) at 3months OCT follow up after stent implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percentage of neointimal coverage at 3 month-OCT after stent implantation
Time Frame: at 3 month-OCT after stent implantation
at 3 month-OCT after stent implantation

Secondary Outcome Measures

Outcome Measure
Time Frame
The occurrence of the composite of cardiac death, MI, definite or probable stent thrombosis, and TIMI-defined major bleeding for 12 months
Time Frame: 12 months after PCI
12 months after PCI
percentage of malposition strut at 3 month-OCT after stent implantation
Time Frame: 3 months after PCI
3 months after PCI
The occurrence of the composite of All cause death, spontaneous MI, Target vessel revascularization and stroke.
Time Frame: 12 months after PCI
12 months after PCI
Target vessel revascularization
Time Frame: 12 months after PCI
12 months after PCI
TIMI-defined major bleeding for 12 months
Time Frame: 12 months after PCI
12 months after PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 2, 2013

Primary Completion (Actual)

April 11, 2017

Study Completion (Actual)

April 11, 2017

Study Registration Dates

First Submitted

December 14, 2012

First Submitted That Met QC Criteria

December 14, 2012

First Posted (Estimate)

December 19, 2012

Study Record Updates

Last Update Posted (Actual)

March 21, 2019

Last Update Submitted That Met QC Criteria

March 19, 2019

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2012-0047

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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