Concurrent OCT and FFR-guided PCI in CAD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorKorea University Guro Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age greater than 19 years old
Patients undergoing coronary stent implantation for stable angina or acute coronary syndrome
Patients provided on informed consent
Disqualifiers
Individuals with a history of increased bleeding tendencies or hematologic disorders
Presented with refractory cardiogenic shock
Individuals with a history of stent thrombosis
Expected life expectancy of less than 1 year
Trial design
Design model
Parallel
Treatments tested in this trial
optical coherence tomography and fractional flow reserve
Diagnostic testThe assessment of pre-procedural lesions and optimization status of implanted stents will involve both intracoronary imaging and physiological indices.
Coronary angiography
Diagnostic testThe assessment of pre-procedural lesions and optimization status of implanted stents will be determined by conventional coronary angiography
Treatment groups
700 Participants
are divided into 2 treatment groupsGroup A: Angiography-guided PCI groupActive comparator 1 intervention
Group B: Concurrent OCT/FFR-guided PCI groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Rate of target vessel failure (TVF)
a composite endpoint of cardiac death, target vessel-related non-fatal myocardial infarction, clinically driven-target vessel revascularization
Time frame
1-yearSecondary outcomes
1
Rate of all-cause mortality
cardiac and non-cardiac death
Time frame
1-year2
Rate of any myocardial infarction (MI)
myocardial infarction due to target vessel and non-target vessel failure
Time frame
1-year3
Rate of clinically-driven target vessel revascularization (TVR)
clinically-driven target vessel revascularization
Time frame
1-year4
Rate of any revascularization
clinically-driven target lesion and non-target lesion revascularization
Time frame
1-yearOther outcomes
1
FFR optimization rate
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
Time frame
Immediately after index procedure2
OCT optimization rate
1\) Post-PCI MSA ≥ 4.5 mm2, and 2) Post-PCI expansion ≥ 80%
Time frame
Immediately after index procedureSponsors and contacts
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Source ClinicalTrials.gov