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

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ClinicalTrials.gov Identifier: NCT03625908
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: OCT-guided PCI Device: Angiography-guided PCI Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1604 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Patients will be assigned by use of OCT-guidance or angiography-guidance for stent implantation.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optical CoherenCe Tomography-gUided Coronary Intervention in Patients With Complex lesIons: a Randomized Controlled Trial (OCCUPI Trial)
Actual Study Start Date : January 9, 2019
Estimated Primary Completion Date : January 15, 2022
Estimated Study Completion Date : July 30, 2023
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: OCT-guided PCI
Patients will receive PCI under OCT-guidance.
 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.
Active Comparator: Angiography-guided PCI
Patients will receive PCI under Angiography-guidance.
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Each component of MACE [ Time Frame: 1 year (except periprocedural MI - within 48 hours) ]
    MACE = composite of cardiac death, myocardial infarction, stent thrombosis, ischemia-driven target vessel revascularization

  2. Any revascularization [ Time Frame: 1 year (except periprocedural MI - within 48 hours) ]
  3. Target lesion revascularization [ Time Frame: 1 year (except periprocedural MI - within 48 hours) ]
  4. Periprocedural myocardial infarction [ Time Frame: 1 year (except periprocedural MI - within 48 hours) ]
    Periprocedural MI - PCI-related myocardial infarction (>5x or >10x ULN)

  5. Bleeding [ Time Frame: 1 year (except periprocedural MI - within 48 hours) ]
    Bleeding defined by BARC and TIMI criteria

  6. Stroke [ Time Frame: 1 year (except periprocedural MI - within 48 hours) ]
  7. Stent thrombosis confirmed by OCT [ Time Frame: 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)

  8. Contrast-induced Nephropathy [ Time Frame: 1 year (except periprocedural MI - within 48 hours) ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03625908


Contacts
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Contact: Yang Soo Jang, MD, Ph.D +82-2-2228-8210 jangys1212@yuhs.ac

Locations
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Korea, Republic of
Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Contact: Yang Soo Jang, MD, PhD       jangys1212@yuhs.ac   
Sponsors and Collaborators
Yonsei University
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03625908    
Other Study ID Numbers: 1-2018-0018
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yonsei University:
Coronary artery disease
Optical coherence tomography
antiplatelet therapy
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases