Concurrent OCT and FFR-guided PCI in CAD (OPTICARE-CAD)

Concurrent OPTIcal Coherence Tomography and frActional Flow REserve-guided Therapeutic Intervention in Patients With Coronary Artery Disease (OPTICARE-CAD)

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Image; Atheroscleroses, Coronary
• Intervention / Treatment: Diagnostic test: Coronary angiography; Diagnostic test: optical coherence tomography and fractional flow reserve

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.

• Study Type: Interventional
• Enrollment (Estimated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dong Oh Kang, MD, PhD; Phone Number: 82-2-2626-3184; Email: gelly9@naver.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 08308
    • Recruiting
    • Korea University Guro Hospital
    • Contact: Dong Oh Kang, MD, PhD; Phone Number: +82-2-2626-3184; Email: gelly9@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Angiography-guided PCI group; This group of patients are intended to undergo PCI with conventional angiography-guidance. Procedural optimization determined by angiographic assessment.	Diagnostic test: Coronary angiography; The assessment of pre-procedural lesions and optimization status of implanted stents will be determined by conventional coronary angiography
Experimental: Concurrent OCT/FFR-guided PCI group; This group of patients are intended to undergo PCI with concurrent OCT/FFR-guidance. Procedural optimization determined by OCT and FFR assessment.	Diagnostic test: Coronary angiography; The assessment of pre-procedural lesions and optimization status of implanted stents will be determined by conventional coronary angiography; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of target vessel failure (TVF)	a composite endpoint of cardiac death, target vessel-related non-fatal myocardial infarction, clinically driven-target vessel revascularization	1-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of all-cause mortality	cardiac and non-cardiac death	1-year
Rate of any myocardial infarction (MI)	myocardial infarction due to target vessel and non-target vessel failure	1-year
Rate of clinically-driven target vessel revascularization (TVR)	clinically-driven target vessel revascularization	1-year
Rate of any revascularization	clinically-driven target lesion and non-target lesion revascularization	1-year
Rate of stent thrombosis (acute, subacute, late, very late)	stent thrombosis based on presenting time after the index procedure	1-year
Rate of BARC-defined bleeding	clinically-relevant bleeding event based on BARC classification	1-year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Immediately after index procedure
OCT optimization rate	1) Post-PCI MSA ≥ 4.5 mm2, and 2) Post-PCI expansion ≥ 80%	Immediately after index procedure

Collaborators and Investigators

• Sponsor: Korea University Guro Hospital
• Investigators: Principal Investigator: Dong Oh Kang, MD, PhD, Korea University Guro Hospital

Publications and helpful links

General Publications

• 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.
• 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 of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 Jan 18;145(3):e4-e17. doi: 10.1161/CIR.0000000000001039. Epub 2021 Dec 9. Erratum In: Circulation. 2022 Mar 15;145(11):e771.
• 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-making: an expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. Eur Heart J. 2019 Aug 14;40(31):2566-2584. doi: 10.1093/eurheartj/ehz332.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: December 25, 2023
• First Posted (Estimated): December 27, 2023

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 25, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Coronary artery disease; Optical coherence tomography; Fractional flow reserve; Percutaneous coronary intervention; Drug-eluting stent; Angiography
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Atherosclerosis
• Other Study ID Numbers: OPTICARE-CAD_v1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data will be available to qualified researchers only upon reasonable request and appropriate proposal to the principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No