Clinical trial NCT03394079: Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention
Official title: A Prospective, Open Label, Multi-center, Dual Arm, Randomized, Pragmatic Trial : Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Vessels
Keywords: OCT
IVUS
PCI
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2018-01-09
Enrollment: 2008
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to compare the clinical efficacy and safety of OCT-guided(optical coherence tomography (OCT)-guided) and IVUS-guided(Intravascular ultrasound (IVUS)-guided) strategies in patients undergoing Percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES) or drug-coated balloons (only for in-stent restenosis) for significant obstructive Coronary artery disease (CAD).

The investigators hypothesize that OCT-guided PCI is non-inferior to IVUS-guided PCI with respect to primary end point of target-vessel failure (cardiac death, target-vessel myocardial infarction \[MI\], or ischemia-driven target-vessel revascularization \[TVR\]) at 1 year after randomization.


Eligibility criteria: Inclusion Criteria:

* Men or women at least 19 years of age
* Subjects with obstructive CAD undergoing PCI with contemporary DES or drug-coated balloons (only for in-stent restenosis) under intracoronary imaging guidance.
* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

* ST-elevation myocardial infarction
* Severe renal dysfunction (eGFR \<30 ml/min/1.73 m2 or serum creatinine level \>1.5 mg/dl), unless patient is on renal replacement therapy.
* Cardiogenic shock or decompensated heart failure with severe LV dysfunction (LVEF) \< 30%
* Life expectancy \< 1 year for any non-cardiac or cardiac causes
* Any lesion characteristics resulting in the expected inability to deliver the IVUS or OCT catheter to the lesion pre- and post-PCI (eg, moderate or severe vessel calcification or tortuosity)
* Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study
* Unwillingness or inability to comply with the procedures described in this protocol

Primary outcomes:
measure: Rate of target vessel failure
timeFrame: 1 year
Secondary outcomes:
measure: Rate of cardiac Death
timeFrame: 1, and 5 years
measure: Rate of target vessel myocardial infarction
timeFrame: 1, and 5 years
measure: Rate of ischemia-driven target vessel revascularization
timeFrame: 1, and 5 years
measure: Rate of death
timeFrame: 1, and 5 years
measure: Rate of myocardial infarction
timeFrame: 1, and 5 years
measure: Rate of stent thrombosis
timeFrame: 1, and 5 years
measure: Rate of stroke
timeFrame: 1, and 5 years
measure: Rate of repeat revascularization
timeFrame: 1, and 5 years
measure: Rate of any hospitalization
timeFrame: 1, and 5 years
measure: Rate of bleeding events
timeFrame: 1, and 5 years
measure: Rate of target-lesion failure
timeFrame: 1, and 5 years
measure: Rate of contrast-induced acute kidney injury
timeFrame: 3 days
measure: Rate of procedural complications requiring active intervention that were related to PCI or intracoronary imaging devices
timeFrame: 1 day
measure: Rate of angiographic or imaging-based device success
timeFrame: 1 day
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang university hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung hee university hospital
Study officials:
affiliation: Professor, Division of Cardiology, Division of Cardiology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, South Korea
name: Duk-woo Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kang DY, Ahn JM, Park H, Lee PH, Kang SJ, Lee SW, Kim YH, Park SW, Kim SW, Hur SH, Cho YK, Lee CH, Hong SJ, Hong YJ, Yoon YW, Kim SJ, Bae JH, Oh JH, Park DW, Park SJ. Comparison of optical coherence tomography-guided versus intravascular ultrasound-guided percutaneous coronary intervention: Rationale and design of a randomized, controlled OCTIVUS trial. Am Heart J. 2020 Oct;228:72-80. doi: 10.1016/j.ahj.2020.08.003. Epub 2020 Aug 8.