Optical CoherenCe Tomography-gUided Coronary Intervention in Patients With Complex lesIons: a Randomized Controlled Trial (OCCUPI Trial)
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Angiography-guided PCIDevice: 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Angiography-guided PCI Angiography-guided PCI Patients will receive PCI under Angiography-guidance. OCT-guided PCI OCT-guided PCI Patients will receive PCI under OCT-guidance.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Any revascularization 1 year (except periprocedural MI - within 48 hours) Stroke 1 year (except periprocedural MI - within 48 hours) Stent optimization confirmed by OCT 1 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 infarction 1 year (except periprocedural MI - within 48 hours) Periprocedural MI - PCI-related myocardial infarction (\>5x or \>10x ULN)
Each component of MACE 1 year (except periprocedural MI - within 48 hours) MACE = composite of cardiac death, myocardial infarction, stent thrombosis, ischemia-driven target vessel revascularization
Target lesion revascularization 1 year (except periprocedural MI - within 48 hours) Bleeding 1 year (except periprocedural MI - within 48 hours) Bleeding defined by BARC and TIMI criteria
Contrast-induced Nephropathy 1 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