Clinical trial NCT06182683: Concurrent OCT and FFR-guided PCI in CAD
Official title: Concurrent OPTIcal Coherence Tomography and frActional Flow REserve-guided Therapeutic Intervention in Patients With Coronary Artery Disease (OPTICARE-CAD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Image
Atheroscleroses, Coronary
Keywords: Optical coherence tomography
Fractional flow reserve
Angiography
Coronary artery disease
Percutaneous coronary intervention
Drug-eluting stent
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 700
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized open-label clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of target vessel failure (TVF)
timeFrame: 1-year
Secondary outcomes:
measure: Rate of all-cause mortality
timeFrame: 1-year
measure: Rate of any myocardial infarction (MI)
timeFrame: 1-year
measure: Rate of clinically-driven target vessel revascularization (TVR)
timeFrame: 1-year
measure: Rate of any revascularization
timeFrame: 1-year
measure: Rate of stent thrombosis (acute, subacute, late, very late)
timeFrame: 1-year
measure: Rate of BARC-defined bleeding
timeFrame: 1-year
Other outcomes:
measure: FFR optimization rate
timeFrame: Immediately after index procedure
measure: OCT optimization rate
timeFrame: Immediately after index procedure
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Dong Oh Kang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Collison D, Didagelos M, Aetesam-Ur-Rahman M, Copt S, McDade R, McCartney P, Ford TJ, McClure J, Lindsay M, Shaukat A, Rocchiccioli P, Brogan R, Watkins S, McEntegart M, Good R, Robertson K, O'Boyle P, Davie A, Khan A, Hood S, Eteiba H, Berry C, Oldroyd KG. Post-stenting fractional flow reserve vs coronary angiography for optimization of percutaneous coronary intervention (TARGET-FFR). Eur Heart J. 2021 Dec 1;42(45):4656-4668. doi: 10.1093/eurheartj/ehab449.