Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention
- Conditions
- Coronary Vessels
- Interventions
- Procedure: PCI
- Registration Number
- NCT03394079
- Lead Sponsor
- Seung-Jung Park
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2008
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OCT-guided PCI - IVUS-guided PCI -
- Primary Outcome Measures
Name Time Method Rate of target vessel failure 1 year 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.
- Secondary Outcome Measures
Name Time Method Rate of stent thrombosis 1, and 5 years Stent thrombosis is defined according to according to the definite or probable criteria of the Academic Research Consortium.
Rate of target-lesion failure 1, and 5 years Cardiac death, target-vessel myocardial infarction or ischemia-driven target-lesion revascularization
Rate of angiographic or imaging-based device success 1 day 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.Rate of cardiac Death 1, and 5 years Rate of death 1, and 5 years cardiac, vascular, non-cardiovascular death
Rate of repeat revascularization 1, and 5 years Any, target-lesion or non-target-lesion, target-vessel or non-target-vessel, ischemia-driven or non-ischemia-driven.
Rate of any hospitalization 1, and 5 years Cardiac or non-cardiac causes.
Rate of myocardial infarction 1, and 5 years periprocedural or spontaneous, Q-wave or non-Q-wave.
Rate of target vessel myocardial infarction 1, and 5 years Rate of ischemia-driven target vessel revascularization 1, and 5 years Rate of contrast-induced acute kidney injury 3 days 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.
Rate of stroke 1, and 5 years 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.
Rate of bleeding events 1, and 5 years Life-threatening or disabling, major bleeding, or minor.
Bleeding events are assessed according to the Bleeding Academic Research Consortium (BARC) criteria.Rate of procedural complications requiring active intervention that were related to PCI or intracoronary imaging devices 1 day 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.
Trial Locations
- Locations (9)
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Kyung hee university hospital
🇰🇷Seoul, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Konyang University Hospital
🇰🇷Daejeon, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Asan Medical Hospital
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Chung-Ang university hospital
🇰🇷Seoul, Korea, Republic of