Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention (OCTIVUS)

December 28, 2025 updated by: Seung-Jung Park

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2008

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Daegu, South Korea
        • Keimyung University Dongsan Medical Center
      • Daejeon, South Korea
        • Konyang University Hospital
      • Gwangju, South Korea
        • Chonnam National University Hospital
      • Pusan, South Korea
        • Pusan National University Hospital
      • Seoul, South Korea
        • Korea University Anam Hospital
      • Seoul, South Korea
        • Gangnam Severance Hospital
      • Seoul, South Korea
        • Chung-Ang University Hospital
      • Seoul, South Korea
        • Kyung Hee University Hospital
      • Seoul, South Korea
        • Asan Medical Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OCT-guided
Procedure: PCI
Percutaneous Coronary Intervention
Active Comparator: IVUS-guided
Procedure: PCI
Percutaneous Coronary Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of target vessel failure
Time Frame: 1 year

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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of cardiac Death
Time Frame: 1, and 5 years
1, and 5 years
Rate of target vessel myocardial infarction
Time Frame: 1, and 5 years
1, and 5 years
Rate of ischemia-driven target vessel revascularization
Time Frame: 1, and 5 years
1, and 5 years
Rate of death
Time Frame: 1, and 5 years
cardiac, vascular, non-cardiovascular death
1, and 5 years
Rate of myocardial infarction
Time Frame: 1, and 5 years
periprocedural or spontaneous, Q-wave or non-Q-wave.
1, and 5 years
Rate of stent thrombosis
Time Frame: 1, and 5 years
Stent thrombosis is defined according to according to the definite or probable criteria of the Academic Research Consortium.
1, and 5 years
Rate of stroke
Time Frame: 1, and 5 years
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.
1, and 5 years
Rate of repeat revascularization
Time Frame: 1, and 5 years
Any, target-lesion or non-target-lesion, target-vessel or non-target-vessel, ischemia-driven or non-ischemia-driven.
1, and 5 years
Rate of any hospitalization
Time Frame: 1, and 5 years
Cardiac or non-cardiac causes.
1, and 5 years
Rate of bleeding events
Time Frame: 1, and 5 years

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

Bleeding events are assessed according to the Bleeding Academic Research Consortium (BARC) criteria.
1, and 5 years
Rate of target-lesion failure
Time Frame: 1, and 5 years
Cardiac death, target-vessel myocardial infarction or ischemia-driven target-lesion revascularization
1, and 5 years
Rate of contrast-induced acute kidney injury
Time Frame: 3 days
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.
3 days
Rate of procedural complications requiring active intervention that were related to PCI or intracoronary imaging devices
Time Frame: 1 day
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.
1 day
Rate of angiographic or imaging-based device success
Time Frame: 1 day

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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seung-Jung Park

Collaborators

CardioVascular Research Foundation, Korea

Investigators

  • Principal Investigator: Duk-woo Park, MD, Professor, Division of Cardiology, Division of Cardiology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, South Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2018

Primary Completion (Actual)

February 17, 2023

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

December 25, 2017

First Submitted That Met QC Criteria

January 3, 2018

First Posted (Actual)

January 9, 2018

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 28, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AMCCV2017-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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