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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)

Primary Purpose

Ischemic Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Angio-guided PCI with EES or BES
OCT-guided PCI with EES or BES
PCI with BES under angio-guide or OCT guide
PCI with EES under angio-guide or OCT guide
Keep DAPT
Discontinue DAPT
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Active Comparator

Arm Label

Angio guided PCI

OCT-guided PCI

BES

EES

Keep dual antiplatelet therapy (DAPT)

Discontinue Dual antiplatelet therapy (DAPT)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 14, 2012
Last Updated
March 19, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01752894
Brief Title
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)
Acronym
DETECT-OCT
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2, 2013 (undefined)
Primary Completion Date
April 11, 2017 (Actual)
Study Completion Date
April 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
776 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Angio guided PCI
Arm Type
Active Comparator
Arm Title
OCT-guided PCI
Arm Type
Experimental
Arm Title
BES
Arm Type
Active Comparator
Arm Title
EES
Arm Type
Experimental
Arm Title
Keep dual antiplatelet therapy (DAPT)
Arm Type
Active Comparator
Arm Description
Study subjects will be allocated into this arm with non-randomization method
Arm Title
Discontinue Dual antiplatelet therapy (DAPT)
Arm Type
Active Comparator
Arm Description
Study subjects will be allocated into this arm with non-randomization method
Intervention Type
Device
Intervention Name(s)
Angio-guided PCI with EES or BES
Intervention Description
Angio-guided intervention
Intervention Type
Device
Intervention Name(s)
OCT-guided PCI with EES or BES
Intervention Description
OCT-guided intervention
Intervention Type
Device
Intervention Name(s)
PCI with BES under angio-guide or OCT guide
Intervention Description
biolimus A9-eluting stent.
Intervention Type
Device
Intervention Name(s)
PCI with EES under angio-guide or OCT guide
Intervention Description
everolimus eluting stent.
Intervention Type
Drug
Intervention Name(s)
Keep DAPT
Intervention Description
maintain DAPT for 12 months according to level of uncovered strut (>6%) at 3months OCT follow up after stent implantation.
Intervention Type
Drug
Intervention Name(s)
Discontinue DAPT
Intervention Description
discontinue DAPT according to level of uncovered strut (≤6%) at 3months OCT follow up after stent implantation.
Primary Outcome Measure Information:
Title
percentage of neointimal coverage at 3 month-OCT after stent implantation
Time Frame
at 3 month-OCT after stent implantation
Secondary Outcome Measure Information:
Title
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
Title
percentage of malposition strut at 3 month-OCT after stent implantation
Time Frame
3 months after PCI
Title
The occurrence of the composite of All cause death, spontaneous MI, Target vessel revascularization and stroke.
Time Frame
12 months after PCI
Title
Target vessel revascularization
Time Frame
12 months after PCI
Title
TIMI-defined major bleeding for 12 months
Time Frame
12 months after PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
30562088
Citation
Lee SY, Ahn CM, Yoon HJ, Hur SH, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Hong MK. Early Follow-Up Optical Coherence Tomographic Findings of Significant Drug-Eluting Stent Malapposition. Circ Cardiovasc Interv. 2018 Dec;11(12):e007192. doi: 10.1161/CIRCINTERVENTIONS.118.007192.
Results Reference
derived
PubMed Identifier
29454763
Citation
Lee SY, Kim JS, Yoon HJ, Hur SH, Lee SG, Kim JW, Hong YJ, Kim KS, Choi SY, Shin DH, Nam CM, Kim BK, Ko YG, Choi D, Jang Y, Hong MK. Early Strut Coverage in Patients Receiving Drug-Eluting Stents and its Implications for Dual Antiplatelet Therapy: A Randomized Trial. JACC Cardiovasc Imaging. 2018 Dec;11(12):1810-1819. doi: 10.1016/j.jcmg.2017.12.014. Epub 2018 Feb 14.
Results Reference
derived

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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)

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