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

Primary Purpose

Coronary Artery Disease

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

OCT-guided PCI

Angiography-guided PCI

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery disease, Optical coherence tomography, antiplatelet therapy

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

OCT-guided PCI

Angiography-guided PCI

Arm Description

Patients will receive PCI under OCT-guidance.

Patients will receive PCI under Angiography-guidance.

Outcomes

Primary Outcome Measures

Composite of major adverse cardiac events (MACEs)

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

Secondary Outcome Measures

Each component of MACE

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

Any revascularization

Target lesion revascularization

Periprocedural myocardial infarction

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

Bleeding

Bleeding defined by BARC and TIMI criteria

Stroke

Stent thrombosis 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)

Contrast-induced Nephropathy

Full Information

NCT ID

NCT03625908

First Posted

June 11, 2018

Last Updated

July 21, 2019

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT03625908

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 9, 2019 (Actual)

Primary Completion Date

January 15, 2022 (Anticipated)

Study Completion Date

July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Coronary artery disease, Optical coherence tomography, antiplatelet therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Model Description

Patients will be assigned by use of OCT-guidance or angiography-guidance for stent implantation.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1604 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

OCT-guided PCI

Arm Type

Active Comparator

Arm Description

Patients will receive PCI under OCT-guidance.

Arm Title

Angiography-guided PCI

Arm Type

Active Comparator

Arm Description

Patients will receive PCI under Angiography-guidance.

Intervention Type

Device

Intervention Name(s)

OCT-guided PCI

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Angiography-guided PCI

Intervention Description

Stent optimization using high-pressure non-compliance balloon will be highly recommend. Balloon size would not be less than the stent diameter.

Primary Outcome Measure Information:

Title

Composite of major adverse cardiac events (MACEs)

Description

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Each component of MACE

Description

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

Time Frame