Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention

N/AActive Not RecruitingNCT03394079

Seung-Jung Park2,008 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,008

Conditions

Coronary Vessels

Interventions

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (9)

Keimyung University Dongsan Medical Center

Daegu, South Korea

Konyang University Hospital

Daejeon, South Korea

Chonnam National University Hospital

Gwangju, South Korea

Pusan National University Hospital

Pusan, South Korea

Asan Medical Hospital

Seoul, South Korea

Chung-Ang university hospital

Seoul, South Korea

Gangnam Severance Hospital

Seoul, South Korea

Korea University Anam Hospital

Seoul, South Korea

Kyung hee university hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Rate of target vessel failure

A composite of cardiac death, target-vessel MI or ischemia-driven TVR) at 1 year after randomization. A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.

Time frame: 1 year

Secondary Outcomes

Rate of cardiac Death

Time frame: 1, and 5 years

Rate of target vessel myocardial infarction

Time frame: 1, and 5 years

Rate of ischemia-driven target vessel revascularization

Time frame: 1, and 5 years

Rate of death

cardiac, vascular, non-cardiovascular death

Time frame: 1, and 5 years

Rate of myocardial infarction

periprocedural or spontaneous, Q-wave or non-Q-wave.

Time frame: 1, and 5 years

Rate of stent thrombosis

Stent thrombosis is defined according to according to the definite or probable criteria of the Academic Research Consortium.

Time frame: 1, and 5 years

Rate of stroke

Stroke is defined as focal loss of neurologic function caused by an ischemic or hemorrhagic event, with residual symptoms lasting at least 24 hours or leading to death.

Time frame: 1, and 5 years

Rate of repeat revascularization

Any, target-lesion or non-target-lesion, target-vessel or non-target-vessel, ischemia-driven or non-ischemia-driven.

Time frame: 1, and 5 years

Rate of any hospitalization

Cardiac or non-cardiac causes.

Time frame: 1, and 5 years

Rate of bleeding events

Life-threatening or disabling, major bleeding, or minor. Bleeding events are assessed according to the Bleeding Academic Research Consortium (BARC) criteria.

Time frame: 1, and 5 years

Rate of target-lesion failure

Cardiac death, target-vessel myocardial infarction or ischemia-driven target-lesion revascularization

Time frame: 1, and 5 years

Rate of contrast-induced acute kidney injury

Contrast-induced nephropathy is defined as either a greater than 25% increase of serum creatinine or an absolute increase in serum creatinine of 0.5 mg/dl within 72 hours after PCI.

Time frame: 3 days

Rate of procedural complications requiring active intervention that were related to PCI or intracoronary imaging devices

Procedural complications (e.g., angiographic dissection of at least type B, coronary perforation, vasospasm, thrombus formation, air embolization, slow flow or no reflow, distal embolization, acute closure, ventricular arrhythmia, cardiac tamponade, or cardiogenic shock) requiring active interventions (prolonged balloon inflations, additional stenting required, thrombus aspiration, pericardiocentesis, cardioversion, or use of mechanical circulatory support devices), which are related to PCI procedures or intravascular imaging evaluation.

Time frame: 1 day

Rate of angiographic or imaging-based device success

Patient- or lesion-level analysis. Angiographic device success is defined as successful PCI at the intended target-lesion with final in-stent residual stenosis of less than 30% by quantitative coronary angiography (QCA). Imaging-based device success is defined as successful PCI at the intended target-lesion, which fulfills the optimal criterial for stent implantation by IVUS or OCT.

Time frame: 1 day