Optical CoherenCe Tomography-gUided Coronary Intervention in Patients With Complex lesIons: a Randomized Controlled Trial (OCCUPI Trial)
1 other identifier
interventional
1,604
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started Jan 2019
Typical duration for not_applicable coronary-artery-disease
1 active site
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
First Submitted
Initial submission to the registry
June 11, 2018
CompletedFirst Posted
Study publicly available on registry
August 10, 2018
CompletedStudy Start
First participant enrolled
January 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 12, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2023
CompletedNovember 14, 2023
November 1, 2023
4.8 years
June 11, 2018
November 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite of major adverse cardiac events (MACEs)
Composite of major adverse cardiac events (MACEs) - for comparison between OCT-guided PCI vs. angiography-guided PCI
1 year
Secondary Outcomes (8)
Each component of MACE
1 year (except periprocedural MI - within 48 hours)
Any revascularization
1 year (except periprocedural MI - within 48 hours)
Target lesion revascularization
1 year (except periprocedural MI - within 48 hours)
Periprocedural myocardial infarction
1 year (except periprocedural MI - within 48 hours)
Bleeding
1 year (except periprocedural MI - within 48 hours)
- +3 more secondary outcomes
Study Arms (2)
OCT-guided PCI
ACTIVE COMPARATORPatients will receive PCI under OCT-guidance.
Angiography-guided PCI
ACTIVE COMPARATORPatients will receive PCI under Angiography-guidance.
Interventions
Patients will receive PCI under OCT-guidance. Predefined criteria for optimization of PCI under OCT-guidance will be recommended to achieve as far as possible.
Stent optimization using high-pressure non-compliance balloon will be highly recommend. Balloon size would not be less than the stent diameter.
Eligibility Criteria
You may qualify if:
- Age 19-85 years
- Patients with ischemic heart diseases (including stable angina, unstable angina and acute myocardial infarction) presented with typical chest pain or objective evidences of myocardial ischemia (positive invasive or non-invasive studies, electrocardiogram (ECG) consistent with ischemia, or elevated cardiac enzymes)
- Complex coronary stenotic lesions (\>50% based on visual estimate) considered for coronary revascularization with DES
- Definition of complex lesions (at least one):
- Acute myocardial infarction
- Chronic total occlusion
- Long lesion: expected stent length ≥28mm based on angiographic estimation
- Calcified lesion
- Bifurcation (including all techniques, one- or two-stent)
- Unprotected left main disease
- Small vessel diseases with reference vessel diameter less than 2.5 mm
- Intracoronary thrombus visible on the angiography
- Stent thrombosis
- In-stent restenosis
- Bypass graft lesion
- +1 more criteria
You may not qualify if:
- Severe hepatic dysfunction (≥3 times normal reference values)
- Significant renal dysfunction (Serum creatinine \>2.0 mg/dL)
- Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3, a white blood cell count of \<3,000 cells/mm3, hemoglobin \<8.0 g/dL, or other known bleeding diathesis
- Hemodynamically unstable during procedures or cardiogenic shock
- Pregnant women or women who might be pregnant
- Life expectancy; less than 1 year
- Inability to understand or read the informed content
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine
Seoul, 03722, South Korea
Related Publications (2)
Lee YJ, Kim Y, Lee OH, Cho DK, Lee SH, Lee SJ, Lee JY, Kim JW, Kim SM, Hur SH, Heo JH, Jang JY, Koh JS, Won H, Lee JW, Hong SJ, Kim DK, Choe JC, Lee JB, Yang TH, Lee JH, Hong YJ, Ahn JH, Hong SJ, Ahn CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y, Kim BK, Occupi Investigators OBOT. Optical coherence tomography-guided percutaneous coronary intervention in acute coronary syndrome patients with complex lesions: a subgroup analysis of the randomised OCCUPI Trial. EuroIntervention. 2025 Nov 3;21(21):e1269-e1280. doi: 10.4244/EIJ-D-25-00478.
PMID: 41489717DERIVEDHong SJ, Lee SJ, Lee SH, Lee JY, Cho DK, Kim JW, Kim SM, Hur SH, Heo JH, Jang JY, Koh JS, Won H, Lee JW, Hong SJ, Kim DK, Choe JC, Lee JB, Kim SJ, Yang TH, Lee JH, Hong YJ, Ahn JH, Lee YJ, Ahn CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y, Kim BK; OCCUPI investigators. 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. Lancet. 2024 Sep 14;404(10457):1029-1039. doi: 10.1016/S0140-6736(24)01454-5. Epub 2024 Sep 2.
PMID: 39236729DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2018
First Posted
August 10, 2018
Study Start
January 9, 2019
Primary Completion
October 12, 2023
Study Completion
October 12, 2023
Last Updated
November 14, 2023
Record last verified: 2023-11