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

Not Applicable
Completed
Conditions
Coronary Artery Disease
Interventions
Device: Angiography-guided PCI
Device: OCT-guided PCI
Registration Number
NCT03625908
Lead Sponsor
Yonsei University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1604
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Angiography-guided PCIAngiography-guided PCIPatients will receive PCI under Angiography-guidance.
OCT-guided PCIOCT-guided PCIPatients will receive PCI under OCT-guidance.
Primary Outcome Measures
NameTimeMethod
Composite of major adverse cardiac events (MACEs)1 year

Composite of major adverse cardiac events (MACEs) - for comparison between OCT-guided PCI vs. angiography-guided PCI

Secondary Outcome Measures
NameTimeMethod
Any revascularization1 year (except periprocedural MI - within 48 hours)
Stroke1 year (except periprocedural MI - within 48 hours)
Stent optimization confirmed by OCT1 year (except periprocedural MI - within 48 hours)

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.

1. 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

2. Stent apposition Optimal - acute stent malposition\<200μm Acceptable - acute stent malposition\<400μm

3. 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)

Periprocedural myocardial infarction1 year (except periprocedural MI - within 48 hours)

Periprocedural MI - PCI-related myocardial infarction (\>5x or \>10x ULN)

Each component of MACE1 year (except periprocedural MI - within 48 hours)

MACE = composite of cardiac death, myocardial infarction, stent thrombosis, ischemia-driven target vessel revascularization

Target lesion revascularization1 year (except periprocedural MI - within 48 hours)
Bleeding1 year (except periprocedural MI - within 48 hours)

Bleeding defined by BARC and TIMI criteria

Contrast-induced Nephropathy1 year (except periprocedural MI - within 48 hours)

Trial Locations

Locations (1)

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

🇰🇷

Seoul, Korea, Republic of

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