NCT03625908

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

Completed NA Last updated 14 November 2023

What this trial tests

NA trial testing OCT-guided PCI in Coronary Artery Disease in 1,604 participants. Completed in 12 October 2023.

Timeline

9 January 2019

Primary endpoint
12 October 2023

12 October 2023

Quick facts

Lead sponsor	Yonsei University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	treatment
Enrollment	1,604
Start date	9 January 2019
Primary completion	12 October 2023
Estimated completion	12 October 2023
Sites	1 location across South Korea

Drugs / interventions tested

• OCT-guided PCI
• Angiography-guided PCI

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

Yonsei University

Who can join

Adults 19 to 85, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

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

1. 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
2. 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.
   Hong SJ, Lee SJ, Lee SH, Lee JY, et al · · 2024 · cited 49× · PMID 39236729 · DOI 10.1016/s0140-6736(24)01454-5
3. 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
4. Widespread Use of Imaging-Guided PCI in Asia: Time for Extended Application.
   Kim Y, Kim JH, Hong SJ, Kim HK, et al · · 2024 · cited 3× · PMID 39371623 · DOI 10.1016/j.jacasi.2024.07.003
5. OCT-Guided PCI According to Lesion Length and Vessel Diameter: Post Hoc Analysis of OCCUPI Trial.
   Roh JW, Lee OH, Heo SJ, Im E, et al · · 2026 · PMID 41999373 · DOI 10.1016/j.jacasi.2026.02.023
6. Optical coherence tomography-guided percutaneous coronary intervention in acute coronary syndrome patients with complex lesions: a subgroup analysis of the randomised OCCUPI Trial.
   Lee YJ, Kim Y, Lee OH, Cho DK, et al · · 2025 · PMID 41489717 · DOI 10.4244/eij-d-25-00478
7. Optical Coherence Tomography-Guided vs. Angiography-Guided Percutaneous Coronary Intervention for Complex Coronary Lesions: A Systematic Review and Meta-Analysis.
   Shuja MH, Ahmed M, Hannat R, Khurram L, et al · · 2025 · PMID 40804871 · DOI 10.3390/diagnostics15151907
8. Current evidence for prognostic benefit of intravascular imaging-guided percutaneous coronary intervention in chronic total occlusion intervention.
   Hong D, Kim SE, Lee SH, Lee SJ, et al · · 2024 · PMID 38419334 · DOI 10.3904/kjim.2023.420