Concurrent OCT and FFR-guided PCI in CAD

Coronary Artery Disease Clinical Trial

— OPTICARE-CAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06182683
• Other study ID #: OPTICARE-CAD_v1
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: December 31, 2029

Study information

• Verified date: December 2023
• Source: Korea University Guro Hospital
• Contact: Dong Oh Kang, MD, PhD
• Phone: 82-2-2626-3184
• Email: gelly9[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atheroscleroses, Coronary
• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Image
• Myocardial Ischemia

Intervention

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.
• Coronary angiography
The assessment of pre-procedural lesions and optimization status of implanted stents will be determined by conventional coronary angiography

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Guro Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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 ?FFR =0.05	Immediately after index procedure
Other	OCT optimization rate	1) Post-PCI MSA = 4.5 mm2, and 2) Post-PCI expansion = 80%	Immediately after index procedure
Primary	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	Rate of all-cause mortality	cardiac and non-cardiac death	1-year
Secondary	Rate of any myocardial infarction (MI)	myocardial infarction due to target vessel and non-target vessel failure	1-year
Secondary	Rate of clinically-driven target vessel revascularization (TVR)	clinically-driven target vessel revascularization	1-year
Secondary	Rate of any revascularization	clinically-driven target lesion and non-target lesion revascularization	1-year
Secondary	Rate of stent thrombosis (acute, subacute, late, very late)	stent thrombosis based on presenting time after the index procedure	1-year
Secondary	Rate of BARC-defined bleeding	clinically-relevant bleeding event based on BARC classification	1-year