Ischemic Heart DiseaseDETECT-OCTNCT01752894
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)
A study testing Angio-guided PCI with EES or BES, OCT-guided PCI with EES or BES and PCI with BES under angio-guide or OCT guide in people with Ischemic Heart Disease, run by Yonsei University at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Angio-guided PCI with EES or BES, OCT-guided PCI with EES or BES and PCI with BES under angio-guide or OCT guide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 776 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jan 2013to 11 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
Seoul, 120-752
About this study
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
- Conditions
- Ischemic Heart Disease
- Being tested
- 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
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angio-guided PCI with EES or BESDevice
Angio-guided intervention
OCT-guided PCI with EES or BESDevice
OCT-guided intervention
PCI with BES under angio-guide or OCT guideDevice
biolimus A9-eluting stent.
PCI with EES under angio-guide or OCT guideDevice
everolimus eluting stent.
Keep DAPTDrug
maintain DAPT for 12 months according to level of uncovered strut (>6%) at 3months OCT follow up after stent implantation.
Discontinue DAPTDrug
discontinue DAPT according to level of uncovered strut (≤6%) at 3months OCT follow up after stent implantation.
| Study group | Role | What they receive |
|---|---|---|
| Angio guided PCI | Active comparator | Not described Receives: Device: Angio-guided PCI with EES or BES |
| OCT-guided PCI | Experimental | Not described Receives: Device: OCT-guided PCI with EES or BES |
| BES | Active comparator | Not described Receives: Device: PCI with BES under angio-guide or OCT guide |
| EES | Experimental | Not described Receives: Device: PCI with EES under angio-guide or OCT guide |
| Keep dual antiplatelet therapy (DAPT) | Active comparator | Study subjects will be allocated into this arm with non-randomization method Receives: Drug: Keep DAPT |
| Discontinue Dual antiplatelet therapy (DAPT) | Active comparator | Study subjects will be allocated into this arm with non-randomization method Receives: Drug: Discontinue DAPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of neointimal coverage at 3 month-OCT after stent implantation
Measured: at 3 month-OCT after stent implantation
Secondary outcomes (5)
The occurrence of the composite of cardiac death, MI, definite or probable stent thrombosis, and TIMI-defined major bleeding for 12 months
Measured: 12 months after PCI
percentage of malposition strut at 3 month-OCT after stent implantation
Measured: 3 months after PCI
The occurrence of the composite of All cause death, spontaneous MI, Target vessel revascularization and stroke.
Measured: 12 months after PCI
Target vessel revascularization
Measured: 12 months after PCI
TIMI-defined major bleeding for 12 months
Measured: 12 months after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study start2 Jan 2013
- Primary completion11 Apr 2017
- Study completion11 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 776 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752894
- Sponsor's protocol ID
- 1-2012-0047
- Acronym
- DETECT-OCT
- Status last verified
- Mar 2018
- First submitted
- 14 Dec 2012
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Jin IT, Kim Y, Heo SJ, Lee YJ, Lee SJ, Hong SJ, Ahn CM, Kim JS, Cho DK, Ko YG, Choi D, Hong MK, Kim BK. Comparison of Short-term and Standard Duration Dual Antiplatelet Therapy in Elderly Patients: A Pooled Analysis of Five Korean Randomized Clinical Trials. Korean Circ J. 2025 Dec;55(12):1125-1137. doi: 10.4070/kcj.2025.0093. Epub 2025 Jul 14.
PubMed 41044734Lee 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.
PubMed 30562088Lee 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.
PubMed 29454763
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT01752894
- Acronym / sponsor ID
- DETECT-OCT / 1-2012-0047
- Conditions
- Ischemic Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 776 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 2 Jan 2013
- Primary completion
- 11 Apr 2017 (actual)
- Study completion
- 11 Apr 2017 (actual)
- First posted
- 19 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Angio guided PCI | Active comparator | Device: Angio-guided PCI with EES or BES |
| OCT-guided PCI | Experimental | Device: OCT-guided PCI with EES or BES |
| BES | Active comparator | Device: PCI with BES under angio-guide or OCT guide |
| EES | Experimental | Device: PCI with EES under angio-guide or OCT guide |
| Keep dual antiplatelet therapy (DAPT) | Active comparator | Drug: Keep DAPTStudy subjects will be allocated into this arm with non-randomization method |
| Discontinue Dual antiplatelet therapy (DAPT) | Active comparator | Drug: Discontinue DAPTStudy subjects will be allocated into this arm with non-randomization method |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angio-guided PCI with EES or BESAngio-guided intervention | Device | Angio guided PCI |
| OCT-guided PCI with EES or BESOCT-guided intervention | Device | OCT-guided PCI |
| PCI with BES under angio-guide or OCT guidebiolimus A9-eluting stent. | Device | BES |
| PCI with EES under angio-guide or OCT guideeverolimus eluting stent. | Device | EES |
| Keep DAPTmaintain DAPT for 12 months according to level of uncovered strut (>6%) at 3months OCT follow up after stent implantation. | Drug | Keep dual antiplatelet therapy (DAPT) |
| Discontinue DAPTdiscontinue DAPT according to level of uncovered strut (≤6%) at 3months OCT follow up after stent implantation. | Drug | Discontinue Dual antiplatelet therapy (DAPT) |
Primary outcome
percentage of neointimal coverage at 3 month-OCT after stent implantation
Time frame: at 3 month-OCT after stent implantation
5 secondary outcomes
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
percentage of malposition strut at 3 month-OCT after stent implantation
Time frame: 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
Target vessel revascularization
Time frame: 12 months after PCI
TIMI-defined major bleeding for 12 months
Time frame: 12 months after PCI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Derived from this study: PubMed 41044734Jin IT, Kim Y, Heo SJ, Lee YJ, Lee SJ, Hong SJ, Ahn CM, Kim JS, Cho DK, Ko YG, Choi D, Hong MK, Kim BK. Comparison of Short-term and Standard Duration Dual Antiplatelet Therapy in Elderly Patients: A Pooled Analysis of Five Korean Randomized Clinical Trials. Korean Circ J. 2025 Dec;55(12):1125-1137. doi: 10.4070/kcj.2025.0093. Epub 2025 Jul 14.
- Derived from this study: PubMed 30562088Lee 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.
- Derived from this study: PubMed 29454763Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angio-guided PCI with EES or BES, OCT-guided PCI with EES or BES and PCI with BES under angio-guide or OCT guide in people with Ischemic Heart Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of neointimal coverage at 3 month-OCT after stent implantation (time frame: at 3 month-OCT after stent implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01752894, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.