Atheroscleroses, Coronary, Coronary Artery Disease, Image
Conditions
Keywords
Optical coherence tomography, Fractional flow reserve, Angiography, Coronary artery disease, Percutaneous coronary intervention, Drug-eluting stent
Brief summary
The present study is a prospective randomized clinical trial aimed to compare the therapeutic strategy of angiography-guided versus concurrent OCT/FFR-guided intervention in patients with coronary artery disease.
Detailed description
Most previous clinical trials have assessed various interventional strategies guided by intravascular imaging (intravascular imaging-guided PCI), fractional flow reserve (FFR-guided PCI), or conventional angiography (angiography-guided PCI) to compare differences in treatment outcomes. Until now, it remains unclear whether optimizing procedures based on both intravascular imaging and fractional flow reserve indices would lead to improved treatment outcomes compared to PCI guided solely by conventional angiography. Moreover, there are no studies comparing a treatment strategy that combines optical coherence tomography (OCT) and FFR to angiography-guided procedures. Hence, this study aims to compare the clinical effectiveness and therapeutic impact of concurrent guidance using FFR and OCT in patients undergoing coronary artery stent implantation, as compared to procedures guided solely by conventional angiography.
Interventions
DIAGNOSTIC_TESToptical coherence tomography and fractional flow reserve
The assessment of pre-procedural lesions and optimization status of implanted stents will involve both intracoronary imaging and physiological indices.
DIAGNOSTIC_TESTCoronary angiography
The assessment of pre-procedural lesions and optimization status of implanted stents will be determined by conventional coronary angiography
Sponsors
Korea University Guro Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No blinding process, open label design
Intervention model description
Prospective, randomized open-label clinical trial
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age greater than 19 years old 2. Patients undergoing coronary stent implantation for stable angina or acute coronary syndrome 3. Patients provided on informed consent
Exclusion criteria
1. Individuals with a history of increased bleeding tendencies or hematologic disorders 2. Presented with refractory cardiogenic shock 3. Individuals with a history of stent thrombosis 4. Expected life expectancy of less than 1 year 5. Left ventricular ejection fraction (LVEF) ≥ 20% 6. Women who are breastfeeding, pregnant, or planning to become pregnant 7. Deemed unsuitable for participation by the investigator 8. Patients unwilling to participate in the clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of target vessel failure (TVF) | 1-year | a composite endpoint of cardiac death, target vessel-related non-fatal myocardial infarction, clinically driven-target vessel revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of stent thrombosis (acute, subacute, late, very late) | 1-year | stent thrombosis based on presenting time after the index procedure |
| Rate of BARC-defined bleeding | 1-year | clinically-relevant bleeding event based on BARC classification |
| Rate of all-cause mortality | 1-year | cardiac and non-cardiac death |
| Rate of clinically-driven target vessel revascularization (TVR) | 1-year | clinically-driven target vessel revascularization |
| Rate of any revascularization | 1-year | clinically-driven target lesion and non-target lesion revascularization |
| Rate of any myocardial infarction (MI) | 1-year | myocardial infarction due to target vessel and non-target vessel failure |
Other
| Measure | Time frame | Description |
|---|---|---|
| FFR optimization rate | Immediately after index procedure | 1\) Post-PCI FFR ≥ 0.90, or 2) Post-PCI FFR (LAD) ≥ 0.82, or 3) Post-PCI FFR (non-LAD) ≥ 0.88, 4) Stent-segment ΔFFR ≤0.05 |
| OCT optimization rate | Immediately after index procedure | 1\) Post-PCI MSA ≥ 4.5 mm2, and 2) Post-PCI expansion ≥ 80% |
Countries
South Korea
Contacts
Primary ContactDong Oh Kang, MD, PhD
Outcome results
None listed