Concurrent OCT and FFR-guided PCI in CAD

NCT ID: NCT06182683

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2029-12-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Image Atheroscleroses, Coronary

Keywords

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Optical coherence tomography Fractional flow reserve Angiography Coronary artery disease Percutaneous coronary intervention Drug-eluting stent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized open-label clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No blinding process, open label design

Study Groups

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Angiography-guided PCI group

This group of patients are intended to undergo PCI with conventional angiography-guidance. Procedural optimization determined by angiographic assessment.

Group Type ACTIVE_COMPARATOR

Coronary angiography

Intervention Type DIAGNOSTIC_TEST

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

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.

Group Type EXPERIMENTAL

optical coherence tomography and fractional flow reserve

Intervention Type DIAGNOSTIC_TEST

The assessment of pre-procedural lesions and optimization status of implanted stents will involve both intracoronary imaging and physiological indices.

Coronary angiography

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Coronary angiography

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea University Guro Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kang Dong Oh

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dong Oh Kang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

Locations

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Korea University Guro Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Dong Oh Kang, MD, PhD

Role: CONTACT

Phone: 82-2-2626-3184

Email: [email protected]

Facility Contacts

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Dong Oh Kang, MD, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 31112213 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34882436 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34279606 (View on PubMed)

Other Identifiers

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OPTICARE-CAD_v1

Identifier Type: -

Identifier Source: org_study_id