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

NCT ID: NCT03625908

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1604 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-09
• Study Completion Date: 2023-10-12

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.

Detailed Description

Eligible patients will be randomly assigned to either OCT-guided PCI arm and angiography-guided PCI with routine high pressure NC ballooning arm in 1:1 ratio. Within OCT-guided PCI arm, the use of OCT will be also assigned to full OCT-guidance arm and postprocedural OCT only arm. and comparison of stent implantation with and without preprocedural OCT will be evaluated by postprocedural OCT (OCT-defined stent optimization will be assessed). In angiography-guided PCI arm, PCI for complex lesion will be performed without guidance of intravascular imaging, and routine use of high pressure postdilation with NC balloon will be also recommended. Primary endpoint will be evaluated during 12 months after PCI.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OCT-guided PCI

Patients will receive PCI under OCT-guidance.

Group Type: ACTIVE_COMPARATOR

OCT-guided PCI

Intervention Type: DEVICE

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.

Angiography-guided PCI

Patients will receive PCI under Angiography-guidance.

Group Type: ACTIVE_COMPARATOR

Angiography-guided PCI

Intervention Type: DEVICE

Stent optimization using high-pressure non-compliance balloon will be highly recommend. Balloon size would not be less than the stent diameter.

Interventions

OCT-guided PCI

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.

Intervention Type: DEVICE

Angiography-guided PCI

Stent optimization using high-pressure non-compliance balloon will be highly recommend. Balloon size would not be less than the stent diameter.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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
• Patients who provide signed informed consent

Exclusion Criteria

• 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine

Seoul, , South Korea

Countries

South Korea

References

Hong 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.

Reference Type: DERIVED

PMID: 39236729 (View on PubMed)

Other Identifiers

1-2018-0018

Identifier Type: -

Identifier Source: org_study_id