Coronary Artery DiseaseOPTICARE-CADNCT06182683
Concurrent OCT and FFR-guided PCI in CAD
A study testing optical coherence tomography and fractional flow reserve and Coronary angiography in people with Coronary Artery Disease and Image, run by Korea University Guro Hospital at 1 site in South Korea.
Trial summary
The present study is a prospective randomized clinical trial aimed to compare the therapeutic strategy of angiography-guided versus concurrent OCT/FFR-guided intervention in patients with coronary artery disease. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Image, Atheroscleroses, Coronary
- What is being tested?
- optical coherence tomography and fractional flow reserve and Coronary angiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Nov 2023to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 19 years old
- Patients undergoing coronary stent implantation for stable angina or acute coronary syndrome
- Patients provided on informed consent
Who cannot join
- Individuals with a history of increased bleeding tendencies or hematologic disorders
- Presented with refractory cardiogenic shock
- Individuals with a history of stent thrombosis
- Expected life expectancy of less than 1 year
- Left ventricular ejection fraction (LVEF) ≥ 20%
- Women who are breastfeeding, pregnant, or planning to become pregnant
- Deemed unsuitable for participation by the investigator
- Patients unwilling to participate in the clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Guro Hospital
Seoul, 08308
Dong Oh Kang, MD, PhD, +82-2-2626-3184, gelly9@naver.com
About this study
Official title: Concurrent OPTIcal Coherence Tomography and frActional Flow REserve-guided Therapeutic Intervention in Patients With Coronary Artery Disease (OPTICARE-CAD)
The present study is a prospective randomized clinical trial aimed to compare the therapeutic strategy of angiography-guided versus concurrent OCT/FFR-guided intervention in patients with coronary artery disease.
Read the detailed description
Most previous clinical trials have assessed various interventional strategies guided by intravascular imaging (intravascular imaging-guided PCI), fractional flow reserve (FFR-guided PCI), or conventional angiography (angiography-guided PCI) to compare differences in treatment outcomes. Until now, it remains unclear whether optimizing procedures based on both intravascular imaging and fractional flow reserve indices would lead to improved treatment outcomes compared to PCI guided solely by conventional angiography. Moreover, there are no studies comparing a treatment strategy that combines optical coherence tomography (OCT) and FFR to angiography-guided procedures. Hence, this study aims to compare the clinical effectiveness and therapeutic impact of concurrent guidance using FFR and OCT in patients undergoing coronary artery stent implantation, as compared to procedures guided solely by conventional angiography.
- Conditions
- Coronary Artery Disease, Image, Atheroscleroses, Coronary
- Being tested
- optical coherence tomography and fractional flow reserve, Coronary angiography
- Keywords
- Optical coherence tomography, Fractional flow reserve, Angiography, Coronary artery disease, Percutaneous coronary intervention, Drug-eluting stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optical coherence tomography and fractional flow reserveDiagnostic test
The assessment of pre-procedural lesions and optimization status of implanted stents will involve both intracoronary imaging and physiological indices.
Coronary angiographyDiagnostic test
The assessment of pre-procedural lesions and optimization status of implanted stents will be determined by conventional coronary angiography
| Study group | Role | What they receive |
|---|---|---|
| Angiography-guided PCI group | Active comparator | This group of patients are intended to undergo PCI with conventional angiography-guidance. Procedural optimization determined by angiographic assessment. Receives: Diagnostic Test: Coronary angiography |
| Concurrent OCT/FFR-guided PCI group | Experimental | This group of patients are intended to undergo PCI with concurrent OCT/FFR-guidance. Procedural optimization determined by OCT and FFR assessment. Receives: Diagnostic Test: optical coherence tomography and fractional flow reserve; Diagnostic Test: Coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of target vessel failure (TVF)
a composite endpoint of cardiac death, target vessel-related non-fatal myocardial infarction, clinically driven-target vessel revascularization
Measured: 1-year
Secondary outcomes (6)
Rate of all-cause mortality
cardiac and non-cardiac death
Measured: 1-year
Rate of any myocardial infarction (MI)
myocardial infarction due to target vessel and non-target vessel failure
Measured: 1-year
Rate of clinically-driven target vessel revascularization (TVR)
clinically-driven target vessel revascularization
Measured: 1-year
Rate of any revascularization
clinically-driven target lesion and non-target lesion revascularization
Measured: 1-year
Rate of stent thrombosis (acute, subacute, late, very late)
stent thrombosis based on presenting time after the index procedure
Measured: 1-year
Rate of BARC-defined bleeding
clinically-relevant bleeding event based on BARC classification
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start30 Nov 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
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 Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Model description
- Prospective, randomized open-label clinical trial
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kang Dong Oh, Korea University Guro Hospital
- Investigators
- Dong Oh Kang, MD, PhD, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182683
- Sponsor's protocol ID
- OPTICARE-CAD_v1
- Acronym
- OPTICARE-CAD
- Status last verified
- Sep 2026
- First submitted
- 28 Nov 2023
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will be available to qualified researchers only upon reasonable request and appropriate proposal to the principal investigator.
Publications
Johnson TW, Raber L, di Mario C, Bourantas C, Jia H, Mattesini A, Gonzalo N, de la Torre Hernandez JM, Prati F, Koskinas K, Joner M, Radu MD, Erlinge D, Regar E, Kunadian V, Maehara A, Byrne RA, Capodanno D, Akasaka T, Wijns W, Mintz GS, Guagliumi G. Clinical use of intracoronary imaging. Part 2: acute coronary syndromes, ambiguous coronary angiography findings, and guiding interventional decision-making: an expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. Eur Heart J. 2019 Aug 14;40(31):2566-2584. doi: 10.1093/eurheartj/ehz332.
PubMed 31112213Lawton JS, Tamis-Holland JE, Bangalore S, Bates ER, Beckie TM, Bischoff JM, Bittl JA, Cohen MG, DiMaio JM, Don CW, Fremes SE, Gaudino MF, Goldberger ZD, Grant MC, Jaswal JB, Kurlansky PA, Mehran R, Metkus TS Jr, Nnacheta LC, Rao SV, Sellke FW, Sharma G, Yong CM, Zwischenberger BA. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 Jan 18;145(3):e4-e17. doi: 10.1161/CIR.0000000000001039. Epub 2021 Dec 9.
PubMed 34882436Collison D, Didagelos M, Aetesam-Ur-Rahman M, Copt S, McDade R, McCartney P, Ford TJ, McClure J, Lindsay M, Shaukat A, Rocchiccioli P, Brogan R, Watkins S, McEntegart M, Good R, Robertson K, O'Boyle P, Davie A, Khan A, Hood S, Eteiba H, Berry C, Oldroyd KG. Post-stenting fractional flow reserve vs coronary angiography for optimization of percutaneous coronary intervention (TARGET-FFR). Eur Heart J. 2021 Dec 1;42(45):4656-4668. doi: 10.1093/eurheartj/ehab449.
PubMed 34279606
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent OPTIcal Coherence Tomography and frActional Flow REserve-guided Therapeutic Intervention in Patients With Coronary Artery Disease (OPTICARE-CAD)
- ClinicalTrials.gov ID
- NCT06182683
- Acronym / sponsor ID
- OPTICARE-CAD / OPTICARE-CAD_v1
- Conditions
- Coronary Artery Disease, Image, Atheroscleroses, Coronary
- Keywords
- Optical coherence tomography, Fractional flow reserve, Angiography, Coronary artery disease, Percutaneous coronary intervention, Drug-eluting stent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 Dec 2023 (actual)
- 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 present study is a prospective randomized clinical trial aimed to compare the therapeutic strategy of angiography-guided versus concurrent OCT/FFR-guided intervention in patients with coronary artery disease.
Detailed description
Most previous clinical trials have assessed various interventional strategies guided by intravascular imaging (intravascular imaging-guided PCI), fractional flow reserve (FFR-guided PCI), or conventional angiography (angiography-guided PCI) to compare differences in treatment outcomes. Until now, it remains unclear whether optimizing procedures based on both intravascular imaging and fractional flow reserve indices would lead to improved treatment outcomes compared to PCI guided solely by conventional angiography. Moreover, there are no studies comparing a treatment strategy that combines optical coherence tomography (OCT) and FFR to angiography-guided procedures. Hence, this study aims to compare the clinical effectiveness and therapeutic impact of concurrent guidance using FFR and OCT in patients undergoing coronary artery stent implantation, as compared to procedures guided solely by conventional angiography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized open-label clinical trial
| Arm | Type | Receives |
|---|---|---|
| Angiography-guided PCI group | Active comparator | Diagnostic Test: Coronary angiographyThis group of patients are intended to undergo PCI with conventional angiography-guidance. Procedural optimization determined by angiographic assessment. |
| Concurrent OCT/FFR-guided PCI group | Experimental | Diagnostic Test: optical coherence tomography and fractional flow reserve, Diagnostic Test: Coronary angiographyThis group of patients are intended to undergo PCI with concurrent OCT/FFR-guidance. Procedural optimization determined by OCT and FFR assessment. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than 19 years old
- Patients undergoing coronary stent implantation for stable angina or acute coronary syndrome
- Patients provided on informed consent
Key exclusion criteria (8 listed)
- Individuals with a history of increased bleeding tendencies or hematologic disorders
- Presented with refractory cardiogenic shock
- Individuals with a history of stent thrombosis
- Expected life expectancy of less than 1 year
- Left ventricular ejection fraction (LVEF) ≥ 20%
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 |
|---|---|---|
| optical coherence tomography and fractional flow reserveThe assessment of pre-procedural lesions and optimization status of implanted stents will involve both intracoronary imaging and physiological indices. | Diagnostic test | Concurrent OCT/FFR-guided PCI group |
| Coronary angiographyThe assessment of pre-procedural lesions and optimization status of implanted stents will be determined by conventional coronary angiography | Diagnostic test | Angiography-guided PCI group, Concurrent OCT/FFR-guided PCI group |
Primary outcome
Rate of target vessel failure (TVF)
Time frame: 1-year
a composite endpoint of cardiac death, target vessel-related non-fatal myocardial infarction, clinically driven-target vessel revascularization
6 secondary outcomes
Rate of all-cause mortality
Time frame: 1-year
Rate of any myocardial infarction (MI)
Time frame: 1-year
Rate of clinically-driven target vessel revascularization (TVR)
Time frame: 1-year
Rate of any revascularization
Time frame: 1-year
Rate of stent thrombosis (acute, subacute, late, very late)
Time frame: 1-year
Rate of BARC-defined bleeding
Time frame: 1-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 31112213Johnson TW, Raber L, di Mario C, Bourantas C, Jia H, Mattesini A, Gonzalo N, de la Torre Hernandez JM, Prati F, Koskinas K, Joner M, Radu MD, Erlinge D, Regar E, Kunadian V, Maehara A, Byrne RA, Capodanno D, Akasaka T, Wijns W, Mintz GS, Guagliumi G. Clinical use of intracoronary imaging. Part 2: acute coronary syndromes, ambiguous coronary angiography findings, and guiding interventional decision-making: an expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. Eur Heart J. 2019 Aug 14;40(31):2566-2584. doi: 10.1093/eurheartj/ehz332.
- Background: PubMed 34882436Lawton JS, Tamis-Holland JE, Bangalore S, Bates ER, Beckie TM, Bischoff JM, Bittl JA, Cohen MG, DiMaio JM, Don CW, Fremes SE, Gaudino MF, Goldberger ZD, Grant MC, Jaswal JB, Kurlansky PA, Mehran R, Metkus TS Jr, Nnacheta LC, Rao SV, Sellke FW, Sharma G, Yong CM, Zwischenberger BA. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 Jan 18;145(3):e4-e17. doi: 10.1161/CIR.0000000000001039. Epub 2021 Dec 9.
- Background: PubMed 34279606Collison D, Didagelos M, Aetesam-Ur-Rahman M, Copt S, McDade R, McCartney P, Ford TJ, McClure J, Lindsay M, Shaukat A, Rocchiccioli P, Brogan R, Watkins S, McEntegart M, Good R, Robertson K, O'Boyle P, Davie A, Khan A, Hood S, Eteiba H, Berry C, Oldroyd KG. Post-stenting fractional flow reserve vs coronary angiography for optimization of percutaneous coronary intervention (TARGET-FFR). Eur Heart J. 2021 Dec 1;42(45):4656-4668. doi: 10.1093/eurheartj/ehab449.
- Individual participant dataSharing planned: Undecided. Individual participant data will be available to qualified researchers only upon reasonable request and appropriate proposal to the principal investigator.
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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.
Dong Oh Kang, MD, PhD principal investigator
Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing optical coherence tomography and fractional flow reserve and Coronary angiography in people with Coronary Artery Disease and Image, run by Korea University Guro Hospital 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 30 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dong Oh Kang, MD, PhD (82-2-2626-3184, gelly9@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of target vessel failure (TVF) (time frame: 1-year). 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 NCT06182683, 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 30 Sep 2026.