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NCT Number: NCT03625908

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 03722, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OCT-guided PCI

Device

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

Device

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

Primary outcomes

  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 outcomes

  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 optimization 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.

    • 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)

  8. Contrast-induced Nephropathy

    Time frame: 1 year (except periprocedural MI - within 48 hours)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 10, 2018
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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