NCT03394079: OCTIVUS

Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention

Active, enrolled NA Last updated 2 January 2026

What this trial tests

NA trial testing PCI in Coronary Vessels in 2,008 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

12 April 2018

Primary endpoint
17 February 2023

31 January 2027

Quick facts

Lead sponsor	Seung-Jung Park
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	2,008
Start date	12 April 2018
Primary completion	17 February 2023
Estimated completion	31 January 2027
Sites	9 locations across South Korea

Drugs / interventions tested

• PCI

Conditions studied

• Coronary Vessels — all drugs for Coronary Vessels →

Sponsor

Seung-Jung Park — full company profile →

Who can join

19 and older, any sex, with Coronary Vessels. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Optical Coherence Tomography-Guided or Intravascular Ultrasound-Guided Percutaneous Coronary Intervention: The OCTIVUS Randomized Clinical Trial.
   Kang DY, Ahn JM, Yun SC, Hur SH, et al · · 2023 · cited 105× · PMID 37634092 · DOI 10.1161/circulationaha.123.066429
2. Intracoronary optical coherence tomography: state of the art and future directions.
   Ali ZA, Karimi Galougahi K, Mintz GS, Maehara A, et al · · 2021 · cited 87× · PMID 34110288 · DOI 10.4244/eij-d-21-00089
3. Guiding Intervention for Complex Coronary Lesions by Optical Coherence Tomography or Intravascular Ultrasound.
   Kang DY, Ahn JM, Yun SC, Hur SH, et al · · 2024 · cited 30× · PMID 37879490 · DOI 10.1016/j.jacc.2023.10.017
4. When to use intravascular ultrasound or optical coherence tomography during percutaneous coronary intervention?
   Nagaraja V, Kalra A, Puri R. · · 2020 · cited 27× · PMID 33224766 · DOI 10.21037/cdt-20-206
5. Optimization of Percutaneous Coronary Intervention Using Optical Coherence Tomography.
   Lee CH, Hur SH. · · 2019 · cited 20× · PMID 31456372 · DOI 10.4070/kcj.2019.0198
6. Intracoronary Imaging: Current Practice and Future Perspectives.
   Tsigkas G, Spyropoulou P, Bousoula E, Apostolos A, et al · · 2023 · cited 6× · PMID 39077408 · DOI 10.31083/j.rcm2402039
7. Proportion and Clinical Impact of Stent Optimization During Imaging-Guided Percutaneous Coronary Intervention: The OCTIVUS Trial.
   Kim H, Kang DY, Ahn JM, Kim HJ, et al · · 2025 · cited 5× · PMID 40272346 · DOI 10.1016/j.jcin.2025.01.436
8. Sex Differences in Cardiovascular Outcomes of Intravascular Imaging-Guided PCI: A Meta-Analysis of Randomized Controlled Trials.
   Ezenna C, Ibrahim S, Ramesh P, Ismayl M, et al · · 2025 · cited 3× · PMID 40829371 · DOI 10.1016/j.jacadv.2025.102076