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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: OCT-guided PCI; Device: Angiography-guided PCI

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.

• Study Type: Interventional
• Enrollment (Actual): 1604
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: OCT-guided PCI; Patients will receive PCI under OCT-guidance.	Device: 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.
Active Comparator: Angiography-guided PCI; Patients will receive PCI under Angiography-guidance.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Each component of MACE	MACE = composite of cardiac death, myocardial infarction, stent thrombosis, ischemia-driven target vessel revascularization	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	Periprocedural MI - PCI-related myocardial infarction (>5x or >10x ULN)	1 year (except periprocedural MI - within 48 hours)
Bleeding	Bleeding defined by BARC and TIMI criteria	1 year (except periprocedural MI - within 48 hours)
Stroke		1 year (except periprocedural MI - within 48 hours)
Contrast-induced Nephropathy		1 year (except periprocedural MI - within 48 hours)
Stent optimization confirmed by OCT	The attainment(optimal or acceptable) of criteria regarding stent expansion is strongly recommended. As for the other criteria, further procedures could be decided by the operators' decisions considering the situations.; Stent expansion Optimal - meeting of all criteria Acceptable - meeting of any one criteria 1) MSA≥80% of mean reference lumen area 2) ≥100% of distal reference lumen area 3) MSA of >4.5 mm2 in non-left main lesion; Stent apposition Optimal - acute stent malposition<200μm Acceptable - acute stent malposition<400μm; Edge dissection(Definition of major edge dissection; any one of the followings) 1) ≥60°of the circumference of the vessel at site of dissection 2) Length of dissection ≥3mm 3) Deeper vessel injury(intramural hematoma or penetration to the media or adventitia)	1 year (except periprocedural MI - within 48 hours)

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2019
• Primary Completion (Actual): October 12, 2023
• Study Completion (Actual): October 12, 2023

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Coronary artery disease; Optical coherence tomography; antiplatelet therapy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 1-2018-0018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No