NCT03394079

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,008

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Apr 2018Jan 2027

First Submitted

Initial submission to the registry

December 25, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 9, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

April 12, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2023

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Expected
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

4.9 years

First QC Date

December 25, 2017

Last Update Submit

December 28, 2025

Conditions

Coronary Vessels

Keywords

OCTIVUSPCI

Outcome Measures

Primary Outcomes (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.

    1 year

Secondary Outcomes (14)

  • Rate of cardiac Death

    1, and 5 years

  • Rate of target vessel myocardial infarction

    1, and 5 years

  • Rate of ischemia-driven target vessel revascularization

    1, and 5 years

  • Rate of death

    1, and 5 years

  • Rate of myocardial infarction

    1, and 5 years

  • +9 more secondary outcomes

Study Arms (2)

OCT-guided

EXPERIMENTAL
Procedure: PCI

IVUS-guided

ACTIVE COMPARATOR
Procedure: PCI

Interventions

PCIPROCEDURE

Percutaneous Coronary Intervention

IVUS-guidedOCT-guided

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Konyang University Hospital

Daejeon, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Pusan National University Hospital

Pusan, South Korea

Location

Asan Medical Hospital

Seoul, South Korea

Location

Chung-Ang university hospital

Seoul, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Kyung hee university hospital

Seoul, South Korea

Location

Related Publications (4)

  • 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.

    PMID: 40272346DERIVED

  • 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.

    PMID: 37879490DERIVED

  • 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.

    PMID: 37634092DERIVED

  • 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.

    PMID: 32871327DERIVED

Study Officials

  • Duk-woo Park, MD

    Professor, Division of Cardiology, Division of Cardiology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, South Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Division of Cardiology, Division of Cardiology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, South Korea

Study Record Dates

First Submitted

December 25, 2017

First Posted

January 9, 2018

Study Start

April 12, 2018

Primary Completion

February 17, 2023

Study Completion (Estimated)

January 31, 2027

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations

KR(9)