Concurrent OCT and FFR-guided PCI in CAD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: optical coherence tomography and fractional flow reserve, Coronary angiography.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease, Image, Atheroscleroses, Coronary. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Concurrent OPTIcal Coherence Tomography and frActional Flow REserve-guided Therapeutic Intervention in Patients With Coronary Artery Disease (OPTICARE-CAD)
Overview
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 test optical 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 test Coronary angiography
The assessment of pre-procedural lesions and optimization status of implanted stents will be determined by conventional coronary angiography
Primary outcome measures
- Rate of target vessel failure (TVF) [Time frame: 1-year]
Secondary outcome measures (6)
- Rate of all-cause mortality [Time frame: 1-year]
- Rate of any myocardial infarction (MI) [Time frame: 1-year]
- Rate of clinically-driven target vessel revascularization (TVR) [Time frame: 1-year]
- Rate of any revascularization [Time frame: 1-year]
- Rate of stent thrombosis (acute, subacute, late, very late) [Time frame: 1-year]
- Rate of BARC-defined bleeding [Time frame: 1-year]
Eligibility criteria
Inclusion criteria
- Age greater than 19 years old
- Patients undergoing coronary stent implantation for stable angina or acute coronary syndrome
- Patients provided on informed consent
Exclusion criteria
- 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
- Left ventricular ejection fraction (LVEF) ≥ 20%
- Women who are breastfeeding, pregnant, or planning to become pregnant
- Deemed unsuitable for participation by the investigator
- Patients unwilling to participate in the clinical trial
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Korea University Guro Hospital — Seoul
Publications
- Johnson TW, Raber L, di Mario C, Bourantas C, Jia H, Mattesini A, Gonzalo N, de la Torre Hernandez JM, Prati F, Koskinas K, Joner M, Radu MD, Erlinge D, Regar E, Kunadian V, Maehara A, Byrne RA, Capodanno D, Akasaka T, Wijns W, Mintz GS, Guagliumi G. Clinical use of intracoronary imaging. Part 2: acute coronary syndromes, ambiguous coronary angiography findings, and guiding interventional decision PMID 31112213
- Lawton JS, Tamis-Holland JE, Bangalore S, Bates ER, Beckie TM, Bischoff JM, Bittl JA, Cohen MG, DiMaio JM, Don CW, Fremes SE, Gaudino MF, Goldberger ZD, Grant MC, Jaswal JB, Kurlansky PA, Mehran R, Metkus TS Jr, Nnacheta LC, Rao SV, Sellke FW, Sharma G, Yong CM, Zwischenberger BA. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: Executive Summary: A Report of the American College PMID 34882436
- 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 PMID 34279606
Identifiers
NCT: NCT06182683 · OPTICARE-CAD_v1