Clinical trial NCT03625908: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Optical coherence tomography
antiplatelet therapy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 1604
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Patients will be assigned by use of OCT-guidance or angiography-guidance for stent implantation.
Primary purpose: TREATMENT

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.

Eligibility 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
  * 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

Primary outcomes:
measure: Composite of major adverse cardiac events (MACEs)
timeFrame: 1 year
Secondary outcomes:
measure: Each component of MACE
timeFrame: 1 year (except periprocedural MI - within 48 hours)
measure: Any revascularization
timeFrame: 1 year (except periprocedural MI - within 48 hours)
measure: Target lesion revascularization
timeFrame: 1 year (except periprocedural MI - within 48 hours)
measure: Periprocedural myocardial infarction
timeFrame: 1 year (except periprocedural MI - within 48 hours)
measure: Bleeding
timeFrame: 1 year (except periprocedural MI - within 48 hours)
measure: Stroke
timeFrame: 1 year (except periprocedural MI - within 48 hours)
measure: Stent optimization confirmed by OCT
timeFrame: 1 year (except periprocedural MI - within 48 hours)
measure: Contrast-induced Nephropathy
timeFrame: 1 year (except periprocedural MI - within 48 hours)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine
Study officials:
References: