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Coronary VesselsOCTIVUSNCT03394079

Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention

A study testing PCI in people with Coronary Vessels, run by Seung-Jung Park at 9 sites in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The primary aim of this study is to compare the clinical efficacy and safety of OCT-guided(optical coherence tomography (OCT)-guided) and IVUS-guided(Intravascular ultrasound (IVUS)-guided) strategies in patients undergoing Percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES) or… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Coronary Vessels
What is being tested?
PCI
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,008 participants
Where
9 sitesSouth Korea
Study dates
12 Apr 2018to 31 Jan 2027
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

  • Men or women at least 19 years of age
  • Subjects with obstructive CAD undergoing PCI with contemporary DES or drug-coated balloons (only for in-stent restenosis) under intracoronary imaging guidance.
  • The patient or guardian agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Who cannot join

  • ST-elevation myocardial infarction
  • Severe renal dysfunction (eGFR <30 ml/min/1.73 m2 or serum creatinine level >1.5 mg/dl), unless patient is on renal replacement therapy.
  • Cardiogenic shock or decompensated heart failure with severe LV dysfunction (LVEF) < 30%
  • Life expectancy < 1 year for any non-cardiac or cardiac causes
  • Any lesion characteristics resulting in the expected inability to deliver the IVUS or OCT catheter to the lesion pre- and post-PCI (eg, moderate or severe vessel calcification or tortuosity)
  • Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study
  • Unwillingness or inability to comply with the procedures described in this protocol

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

South Korea9 sites

  • Keimyung University Dongsan Medical Center

    Daegu

  • Konyang University Hospital

    Daejeon

  • Chonnam National University Hospital

    Gwangju

  • Pusan National University Hospital

    Pusan

  • Asan Medical Hospital

    Seoul

  • Chung-Ang university hospital

    Seoul

  • Gangnam Severance Hospital

    Seoul

  • Korea University Anam Hospital

    Seoul

  • Kyung hee university hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Prospective, Open Label, Multi-center, Dual Arm, Randomized, Pragmatic Trial : Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention

The primary aim of this study is to compare the clinical efficacy and safety of OCT-guided(optical coherence tomography (OCT)-guided) and IVUS-guided(Intravascular ultrasound (IVUS)-guided) strategies in patients undergoing Percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES) or drug-coated balloons (only for in-stent restenosis) for significant obstructive Coronary artery disease (CAD).

The investigators hypothesize that OCT-guided PCI is non-inferior to IVUS-guided PCI with respect to primary end point of target-vessel failure (cardiac death, target-vessel myocardial infarction [MI], or ischemia-driven target-vessel revascularization [TVR]) at 1 year after randomization.

Being tested
PCI
Keywords
OCT, IVUS, PCI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PCIProcedure or surgery

    Percutaneous Coronary Intervention

Study groups in NCT03394079
Study groupRoleWhat they receive
OCT-guidedExperimentalNot described
Receives: Procedure: PCI
IVUS-guidedActive comparatorNot described
Receives: Procedure: PCI

What is being measured

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

  1. Rate of target vessel failure

    A composite of cardiac death, target-vessel MI or ischemia-driven TVR) at 1 year after randomization.

    A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.

    Measured: 1 year

Secondary outcomes (15)

  1. Rate of cardiac Death

    Measured: 1, and 5 years

  2. Rate of target vessel myocardial infarction

    Measured: 1, and 5 years

  3. Rate of ischemia-driven target vessel revascularization

    Measured: 1, and 5 years

  4. Rate of death

    cardiac, vascular, non-cardiovascular death

    Measured: 1, and 5 years

  5. Rate of myocardial infarction

    periprocedural or spontaneous, Q-wave or non-Q-wave.

    Measured: 1, and 5 years

  6. Rate of stent thrombosis

    Stent thrombosis is defined according to according to the definite or probable criteria of the Academic Research Consortium.

    Measured: 1, and 5 years

  7. Rate of stroke

    Stroke is defined as focal loss of neurologic function caused by an ischemic or hemorrhagic event, with residual symptoms lasting at least 24 hours or leading to death.

    Measured: 1, and 5 years

  8. Rate of repeat revascularization

    Any, target-lesion or non-target-lesion, target-vessel or non-target-vessel, ischemia-driven or non-ischemia-driven.

    Measured: 1, and 5 years

  9. Rate of any hospitalization

    Cardiac or non-cardiac causes.

    Measured: 1, and 5 years

  10. Rate of bleeding events

    Life-threatening or disabling, major bleeding, or minor.

    Bleeding events are assessed according to the Bleeding Academic Research Consortium (BARC) criteria.

    Measured: 1, and 5 years

  11. Rate of target-lesion failure

    Cardiac death, target-vessel myocardial infarction or ischemia-driven target-lesion revascularization

    Measured: 1, and 5 years

  12. Rate of contrast-induced acute kidney injury

    Contrast-induced nephropathy is defined as either a greater than 25% increase of serum creatinine or an absolute increase in serum creatinine of 0.5 mg/dl within 72 hours after PCI.

    Measured: 3 days

  13. Rate of procedural complications requiring active intervention that were related to PCI or intracoronary imaging devices

    Procedural complications (e.g., angiographic dissection of at least type B, coronary perforation, vasospasm, thrombus formation, air embolization, slow flow or no reflow, distal embolization, acute closure, ventricular arrhythmia, cardiac tamponade, or cardiogenic shock) requiring active interventions (prolonged balloon inflations, additional stenting required, thrombus aspiration, pericardiocentesis, cardioversion, or use of mechanical circulatory support devices), which are related to PCI procedures or intravascular imaging evaluation.

    Measured: 1 day

  14. Rate of angiographic or imaging-based device success

    Patient- or lesion-level analysis.

    Angiographic device success is defined as successful PCI at the intended target-lesion with final in-stent residual stenosis of less than 30% by quantitative coronary angiography (QCA). Imaging-based device success is defined as successful PCI at the intended target-lesion, which fulfills the optimal criterial for stent implantation by IVUS or OCT.

    Measured: 1 day

  15. Rate of target vessel failure

    A composite of cardiac death, target-vessel MI or ischemia-driven TVR)

    A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.

    Measured: 5 year

Timeline

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

  1. First posted9 Jan 2018
  2. Study start12 Apr 2018
  3. Primary completion17 Feb 2023
  4. Study completion31 Jan 2027 (estimated)

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
Parallel groups
Masking
None (open label)
Enrolment
2,008 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03394079
Sponsor's protocol ID
AMCCV2017-10
Acronym
OCTIVUS
Status last verified
Oct 2026
First submitted
25 Dec 2017
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Wee SB, Kang DY, Ahn JM, Park HS, An SY, Seo KW, Lee SH, Yun SC, Baek S, Hur SH, Cho YK, Lee CH, Hong SJ, Lim S, Kim SW, Won H, Hong YJ, Yoon YH, Yoon YW, Bae JH, Park SJ, Park DW; OCTIVUS Investigators. Percutaneous Coronary Intervention Guided by Optical Coherence Tomography or Intravascular Ultrasound for True Bifurcation Lesions. JACC Asia. 2026 Mar 31:S2772-3747(26)00118-3. doi: 10.1016/j.jacasi.2026.02.019. Online ahead of print.

    PubMed 41999374

  • Kim H, Kang DY, Ahn JM, Kim HJ, Hur SH, Cho YK, Lee CH, Hong SJ, Kim SW, Won H, Oh JH, Hong YJ, Yoon YH, Park SJ, Park DW; OCTIVUS Investigators. Proportion and Clinical Impact of Stent Optimization During Imaging-Guided Percutaneous Coronary Intervention: The OCTIVUS Trial. JACC Cardiovasc Interv. 2025 May 12;18(9):1089-1099. doi: 10.1016/j.jcin.2025.01.436. Epub 2025 Apr 23.

    PubMed 40272346

  • Kang DY, Ahn JM, Yun SC, Hur SH, Cho YK, Lee CH, Hong SJ, Lim S, Kim SW, Won H, Oh JH, Choe JC, Hong YJ, Yoon YH, Kim H, Choi Y, Lee J, Yoon YW, Kim SJ, Bae JH, Park SJ, Park DW; OCTIVUS Investigators. Guiding Intervention for Complex Coronary Lesions by Optical Coherence Tomography or Intravascular Ultrasound. J Am Coll Cardiol. 2024 Jan 23;83(3):401-413. doi: 10.1016/j.jacc.2023.10.017. Epub 2023 Oct 23.

    PubMed 37879490

  • Kang DY, Ahn JM, Yun SC, Hur SH, Cho YK, Lee CH, Hong SJ, Lim S, Kim SW, Won H, Oh JH, Choe JC, Hong YJ, Yoon YH, Kim H, Choi Y, Lee J, Yoon YW, Kim SJ, Bae JH, Park DW, Park SJ; OCTIVUS Investigators. Optical Coherence Tomography-Guided or Intravascular Ultrasound-Guided Percutaneous Coronary Intervention: The OCTIVUS Randomized Clinical Trial. Circulation. 2023 Oct 17;148(16):1195-1206. doi: 10.1161/CIRCULATIONAHA.123.066429. Epub 2023 Aug 27.

    PubMed 37634092

  • Kang DY, Ahn JM, Park H, Lee PH, Kang SJ, Lee SW, Kim YH, Park SW, Kim SW, Hur SH, Cho YK, Lee CH, Hong SJ, Hong YJ, Yoon YW, Kim SJ, Bae JH, Oh JH, Park DW, Park SJ. Comparison of optical coherence tomography-guided versus intravascular ultrasound-guided percutaneous coronary intervention: Rationale and design of a randomized, controlled OCTIVUS trial. Am Heart J. 2020 Oct;228:72-80. doi: 10.1016/j.ahj.2020.08.003. Epub 2020 Aug 8.

    PubMed 32871327

Questions about this trial

What is this clinical trial studying?

A study testing PCI in people with Coronary Vessels, run by Seung-Jung Park at 9 sites 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 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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?

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?

Rate of target vessel failure (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 NCT03394079, which also lists 5 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 16 Oct 2026.

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