ClinicalTrials.gg
RecruitingNCT06182683OPTICARE-CADUpdated Sep 30, 2026

Concurrent OCT and FFR-guided PCI in CAD

An interventional study of optical coherence tomography and fractional flow reserve and Coronary angiography in Coronary Artery Disease, Image and Atheroscleroses, Coronary, sponsored by Korea University Guro Hospital. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Korea University Guro Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2023; still recruiting 2 years 11 months later.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
700
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 361 studies in Coronary Artery Disease with a site in Korea, Republic of — 81 open to participants now, 103 under way, 2 of them phase 3. Coronary Artery Disease · Korea, Republic of.

Planned enrollment
89th of 208
700 · median 472
Started
2023
with 23 others
No phase
91 of 361
32 open now
Primary completion
2028-12
later than 69 of 102 live
Registered
319th of 361
by date
Lead sponsor
5 of 361
Korea University Guro Hospital

Among the 361 studies in Coronary Artery Disease with a site in Korea, Republic of, this one is the 89th largest by planned enrollment of the 208 interventional ones that give a count, is one of 24 that started in 2023, is one of 91 with no phase, reaches primary completion later than 69 of the 102 other live ones, and was the 319th registered.

Coronary Artery Disease

4,862 studies on the registry are indexed under Coronary Artery Disease; 893 are open to participants now.

Browse Coronary Artery Disease studies →

Open to participants now

81 of the 361 studies in Coronary Artery Disease with a site in Korea, Republic of are open now. Recruiting first, the newest first:

76 more — sign in →

All 81 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 589 Coronary Artery Disease studies recruiting now, 403 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 48 take healthy volunteers.

This study: 19 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 361 studies in Coronary Artery Disease with a site in Korea, Republic of, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Coronary Artery Disease
  • Image
  • Atheroscleroses, Coronary

Keywords

  • Optical coherence tomography
  • Fractional flow reserve
  • Angiography
  • Coronary artery disease
  • Percutaneous coronary intervention
  • Drug-eluting stent
04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age greater than 19 years old
  2. Patients undergoing coronary stent implantation for stable angina or acute coronary syndrome
  3. Patients provided on

Exclusion criteria

Exclusion Criteria:

  1. Individuals with a history of increased bleeding tendencies or hematologic disorders
  2. Presented with cardiogenic shock
  3. Individuals with a history of stent thrombosis
  4. Expected of less than 1 year
  5. (LVEF) ≥ 20%
  6. Women who are breastfeeding, pregnant, or planning to become pregnant
  7. Deemed unsuitable for participation by the investigator
  8. Patients unwilling to participate in the clinical trial
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
700 participants (estimated)

Study arms

  • Active comparator
    Angiography-guided PCI group

    This group of patients are intended to undergo PCI with conventional angiography-guidance. Procedural optimization determined by angiographic assessment.

    Diagnostic Test: Coronary angiography

  • Experimental
    Concurrent OCT/FFR-guided PCI group

    This group of patients are intended to undergo PCI with concurrent OCT/FFR-guidance. Procedural optimization determined by OCT and FFR assessment.

    Diagnostic Test: optical coherence tomography and fractional flow reserve · Diagnostic Test: Coronary angiography

Interventions

  • Diagnostic testoptical coherence tomography and fractional flow reserve

    The assessment of pre-procedural lesions and optimization status of implanted stents will involve both intracoronary imaging and physiological indices.

  • Diagnostic testCoronary angiography

    The assessment of pre-procedural lesions and optimization status of implanted stents will be determined by conventional coronary angiography

06

What researchers measure

Primary outcomes

  1. Rate of target vessel failure (TVF)

    a composite endpoint of cardiac death, target vessel-related non-fatal myocardial infarction, clinically driven-target vessel revascularization

    Time frame: 1-year

Secondary outcomes

  1. Rate of all-cause mortality

    cardiac and non-cardiac death

    Time frame: 1-year

  2. Rate of any myocardial infarction (MI)

    myocardial infarction due to target vessel and non-target vessel failure

    Time frame: 1-year

  3. Rate of clinically-driven target vessel revascularization (TVR)

    clinically-driven target vessel revascularization

    Time frame: 1-year

  4. Rate of any revascularization

    clinically-driven target lesion and non-target lesion revascularization

    Time frame: 1-year

  5. Rate of stent thrombosis (acute, subacute, late, very late)

    stent thrombosis based on presenting time after the index procedure

    Time frame: 1-year

  6. Rate of BARC-defined bleeding

    clinically-relevant bleeding event based on BARC classification

    Time frame: 1-year

Other outcomes

  1. FFR optimization rate

    1\) Post-PCI FFR ≥ 0.90, or 2) Post-PCI FFR (LAD) ≥ 0.82, or 3) Post-PCI FFR (non-LAD) ≥ 0.88, 4) Stent-segment ΔFFR ≤0.05

    Time frame: Immediately after index procedure

  2. OCT optimization rate

    1\) Post-PCI MSA ≥ 4.5 mm2, and 2) Post-PCI expansion ≥ 80%

    Time frame: Immediately after index procedure

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 31112213 ↗
  • Lawton 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 34882436 ↗
  • Collison 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 ↗

Individual participant data

Plan to share: Undecided — Individual participant data will be available to qualified researchers only upon reasonable request and appropriate proposal to the principal investigator.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2023 (actual). Primary completion is estimated for Dec 2028, 61 months after the start.

Of 753 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 61 months is above that.

Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 28, 2023
First posted
Dec 27, 2023
StartActual
Nov 30, 2023
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2029
Last update
Sep 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Secondary outcomes
2 description edited
What changed in the outcomes
  • Descriptionother outcomeFFR optimization rate: how it is measured was reworded
  • Descriptionother outcomeOCT optimization rate: how it is measured was reworded
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Secondary outcomes 2 description edited
    What changed in the outcomes
    • Descriptionother outcomeFFR optimization rate: how it is measured was reworded
    • Descriptionother outcomeOCT optimization rate: how it is measured was reworded
    + 4 other changes: index terms, verification date, site details and references

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06182683
Lead sponsor
Korea University Guro Hospital
Responsible party
Kang Dong Oh (Assistant Professor, Korea University Guro Hospital) — Principal investigator
First posted
Dec 27, 2023
Start date
Nov 30, 2023
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Sep 30, 2026

Study contacts

Dong Oh Kang, MD, PhD
Contact
gelly9@naver.com
82-2-2626-3184
Dong Oh Kang, MD, PhD
principal investigator · Korea University Guro Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion