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Coronary Artery DiseaseNCT03625908

Optical CoherenCe Tomography-gUided Coronary Intervention in Patients With Complex lesIons: a Randomized Controlled Trial (OCCUPI Trial)

A study testing OCT-guided PCI and Angiography-guided PCI in people with Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There is no definite conclusive work about the benefit of OCT-guided PCI, which should be determined in complex PCI, assuming better stent optimization by OCT. In the study, we will explore the clinical implication of OCT-guided PCI of complex lesions. Read more about this study

Who is it for?
Ages 19 to 85 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
OCT-guided PCI and Angiography-guided PCI
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,604 participants
Where
1 siteSouth Korea
Study dates
9 Jan 2019to 12 Oct 2023
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 19 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 19-85 years
  • Patients with ischemic heart diseases (including stable angina, unstable angina and acute myocardial infarction) presented with typical chest pain or objective evidences of myocardial ischemia (positive invasive or non-invasive studies, electrocardiogram (ECG) consistent with ischemia, or elevated cardiac enzymes)
  • Complex coronary stenotic lesions (>50% based on visual estimate) considered for coronary revascularization with DES
  • Definition of complex lesions (at least one):
  • Acute myocardial infarction
  • Chronic total occlusion
Show all 16Show fewer
  • Long lesion: expected stent length ≥28mm based on angiographic estimation
  • Calcified lesion
  • Bifurcation (including all techniques, one- or two-stent)
  • Unprotected left main disease
  • Small vessel diseases with reference vessel diameter less than 2.5 mm
  • Intracoronary thrombus visible on the angiography
  • Stent thrombosis
  • In-stent restenosis
  • Bypass graft lesion
  • Patients who provide signed informed consent

Who cannot join

  • Severe hepatic dysfunction (≥3 times normal reference values)
  • Significant renal dysfunction (Serum creatinine >2.0 mg/dL)
  • Platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a white blood cell count of <3,000 cells/mm3, hemoglobin <8.0 g/dL, or other known bleeding diathesis
  • Hemodynamically unstable during procedures or cardiogenic shock
  • Pregnant women or women who might be pregnant
  • Life expectancy; less than 1 year
  • Inability to understand or read the informed content

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine

    Seoul, 03722

Other trials in South Korea

About this study

There is no definite conclusive work about the benefit of OCT-guided PCI, which should be determined in complex PCI, assuming better stent optimization by OCT. In the study, we will explore the clinical implication of OCT-guided PCI of complex lesions.

Read the detailed description

Eligible patients will be randomly assigned to either OCT-guided PCI arm and angiography-guided PCI with routine high pressure NC ballooning arm in 1:1 ratio. Within OCT-guided PCI arm, the use of OCT will be also assigned to full OCT-guidance arm and postprocedural OCT only arm. and comparison of stent implantation with and without preprocedural OCT will be evaluated by postprocedural OCT (OCT-defined stent optimization will be assessed). In angiography-guided PCI arm, PCI for complex lesion will be performed without guidance of intravascular imaging, and routine use of high pressure postdilation with NC balloon will be also recommended. Primary endpoint will be evaluated during 12 months after PCI.

Being tested
OCT-guided PCI, Angiography-guided PCI
Keywords
Coronary artery disease, Optical coherence tomography, antiplatelet therapy
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.

  • OCT-guided PCIDevice

    Patients will receive PCI under OCT-guidance. Predefined criteria for optimization of PCI under OCT-guidance will be recommended to achieve as far as possible.

  • Angiography-guided PCIDevice

    Stent optimization using high-pressure non-compliance balloon will be highly recommend. Balloon size would not be less than the stent diameter.

Study groups in NCT03625908
Study groupRoleWhat they receive
OCT-guided PCIActive comparatorPatients will receive PCI under OCT-guidance.
Receives: Device: OCT-guided PCI
Angiography-guided PCIActive comparatorPatients will receive PCI under Angiography-guidance.
Receives: Device: Angiography-guided PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of major adverse cardiac events (MACEs)

    Composite of major adverse cardiac events (MACEs) - for comparison between OCT-guided PCI vs. angiography-guided PCI

    Measured: 1 year

Secondary outcomes (8)

  1. Each component of MACE

    MACE = composite of cardiac death, myocardial infarction, stent thrombosis, ischemia-driven target vessel revascularization

    Measured: 1 year (except periprocedural MI - within 48 hours)

  2. Any revascularization

    Measured: 1 year (except periprocedural MI - within 48 hours)

  3. Target lesion revascularization

    Measured: 1 year (except periprocedural MI - within 48 hours)

  4. Periprocedural myocardial infarction

    Periprocedural MI - PCI-related myocardial infarction (>5x or >10x ULN)

    Measured: 1 year (except periprocedural MI - within 48 hours)

  5. Bleeding

    Bleeding defined by BARC and TIMI criteria

    Measured: 1 year (except periprocedural MI - within 48 hours)

  6. Stroke

    Measured: 1 year (except periprocedural MI - within 48 hours)

  7. Stent optimization confirmed by OCT

    The attainment(optimal or acceptable) of criteria regarding stent expansion is strongly recommended. As for the other criteria, further procedures could be decided by the operators' decisions considering the situations.

    1. Stent expansion Optimal - meeting of all criteria Acceptable - meeting of any one criteria 1) MSA≥80% of mean reference lumen area 2) ≥100% of distal reference lumen area 3) MSA of >4.5 mm2 in non-left main lesion
    2. Stent apposition Optimal - acute stent malposition<200μm Acceptable - acute stent malposition<400μm
    3. Edge dissection(Definition of major edge dissection; any one of the followings) 1) ≥60°of the circumference of the vessel at site of dissection 2) Length of dissection ≥3mm 3) Deeper vessel injury(intramural hematoma or penetration to the media or adventitia)

    Measured: 1 year (except periprocedural MI - within 48 hours)

  8. Contrast-induced Nephropathy

    Measured: 1 year (except periprocedural MI - within 48 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2018
  2. Study start9 Jan 2019
  3. Primary completion12 Oct 2023
  4. Study completion12 Oct 2023

Resources

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
Factorial
Model description
Patients will be assigned by use of OCT-guidance or angiography-guidance for stent implantation.
Masking
None (open label)
Enrolment
1,604 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03625908
Sponsor's protocol ID
1-2018-0018
Status last verified
Nov 2023
First submitted
11 Jun 2018
Last updated
14 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lee SH, Lee YJ, Lee SJ, Ahn CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y, Kim BK, Hong SJ; OCCUPI investigators. Optimization Process After Angiography-Guided Stent Implantation: Pre-specified Analysis of the OCCUPI Randomized Trial. Eur Heart J Cardiovasc Imaging. 2026 Sep 29:jeag276. doi: 10.1093/ehjci/jeag276. Online ahead of print.

    PubMed 42806467

  • Roh JW, Lee OH, Heo SJ, Im E, Cho DK, Lee SJ, Lee JY, Kim JW, Kim SM, Hur SH, Heo JH, Jang JY, Koh JS, Won H, Lee JW, Hong SJ, Kim DK, Choe JC, Lee JB, Yang TH, Lee JH, Hong YJ, Ahn JH, Hong SJ, Ahn CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y, Kim Y, Kim BK; OCCUPI Investigators. OCT-Guided PCI According to Lesion Length and Vessel Diameter: Post Hoc Analysis of OCCUPI Trial. JACC Asia. 2026 Jul;6(7):1062-1074. doi: 10.1016/j.jacasi.2026.02.023. Epub 2026 Apr 18.

    PubMed 41999373

  • Lee YJ, Kim Y, Lee OH, Cho DK, Lee SH, Lee SJ, Lee JY, Kim JW, Kim SM, Hur SH, Heo JH, Jang JY, Koh JS, Won H, Lee JW, Hong SJ, Kim DK, Choe JC, Lee JB, Yang TH, Lee JH, Hong YJ, Ahn JH, Hong SJ, Ahn CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y, Kim BK, Occupi Investigators OBOT. Optical coherence tomography-guided percutaneous coronary intervention in acute coronary syndrome patients with complex lesions: a subgroup analysis of the randomised OCCUPI Trial. EuroIntervention. 2025 Nov 3;21(21):e1269-e1280. doi: 10.4244/EIJ-D-25-00478.

    PubMed 41489717

  • Hong SJ, Lee SJ, Lee SH, Lee JY, Cho DK, Kim JW, Kim SM, Hur SH, Heo JH, Jang JY, Koh JS, Won H, Lee JW, Hong SJ, Kim DK, Choe JC, Lee JB, Kim SJ, Yang TH, Lee JH, Hong YJ, Ahn JH, Lee YJ, Ahn CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y, Kim BK; OCCUPI investigators. Optical coherence tomography-guided versus angiography-guided percutaneous coronary intervention for patients with complex lesions (OCCUPI): an investigator-initiated, multicentre, randomised, open-label, superiority trial in South Korea. Lancet. 2024 Sep 14;404(10457):1029-1039. doi: 10.1016/S0140-6736(24)01454-5. Epub 2024 Sep 2.

    PubMed 39236729

Questions about this trial

What is this clinical trial studying?

A study testing OCT-guided PCI and Angiography-guided PCI in people with Coronary Artery 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 16 inclusion and 7 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 14 Nov 2023. 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?

Composite of major adverse cardiac events (MACEs) (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 NCT03625908, which also lists 4 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 14 Nov 2023.

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