Optical CoherenCe Tomography-gUided Coronary Intervention in Patients With Complex lesIons: a Randomized Controlled Trial (OCCUPI Trial)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Yonsei University
- Enrollment
- 1604
- Locations
- 1
- Primary Endpoint
- Composite of major adverse cardiac events (MACEs)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Composite of major adverse cardiac events (MACEs)
Time Frame: 1 year
Composite of major adverse cardiac events (MACEs) - for comparison between OCT-guided PCI vs. angiography-guided PCI
Secondary Outcomes
- Stroke(1 year (except periprocedural MI - within 48 hours))
- Stent optimization confirmed by OCT(1 year (except periprocedural MI - within 48 hours))
- Periprocedural myocardial infarction(1 year (except periprocedural MI - within 48 hours))
- 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))
- Bleeding(1 year (except periprocedural MI - within 48 hours))
- Contrast-induced Nephropathy(1 year (except periprocedural MI - within 48 hours))