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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03625908
• Other study ID #: 1-2018-0018
• Status: Completed
• Phase: N/A
• Start date: January 9, 2019
• Est. completion date: October 12, 2023

Study information

• Verified date: November 2023
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1604
• Est. completion date: October 12, 2023
• Est. primary completion date: October 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Any revascularization		1 year (except periprocedural MI - within 48 hours)
Secondary	Target lesion revascularization		1 year (except periprocedural MI - within 48 hours)
Secondary	Periprocedural myocardial infarction	Periprocedural MI - PCI-related myocardial infarction (>5x or >10x ULN)	1 year (except periprocedural MI - within 48 hours)
Secondary	Bleeding	Bleeding defined by BARC and TIMI criteria	1 year (except periprocedural MI - within 48 hours)
Secondary	Stroke		1 year (except periprocedural MI - within 48 hours)
Secondary	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)
Secondary	Contrast-induced Nephropathy		1 year (except periprocedural MI - within 48 hours)