NCT06182683

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
44mo left

Started Nov 2023

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Nov 2023Dec 2029

First Submitted

Initial submission to the registry

November 28, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

November 30, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 27, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

5.1 years

First QC Date

November 28, 2023

Last Update Submit

December 25, 2023

Conditions

Coronary Artery DiseaseImageAtheroscleroses, Coronary

Keywords

Optical coherence tomographyFractional flow reserveAngiographyCoronary artery diseasePercutaneous coronary interventionDrug-eluting stent

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Rate of all-cause mortality

    1-year

  • Rate of any myocardial infarction (MI)

    1-year

  • Rate of clinically-driven target vessel revascularization (TVR)

    1-year

  • Rate of any revascularization

    1-year

  • Rate of stent thrombosis (acute, subacute, late, very late)

    1-year

  • +1 more secondary outcomes

Other Outcomes (2)

  • FFR optimization rate

    Immediately after index procedure

  • OCT optimization rate

    Immediately after index procedure

Study Arms (2)

Angiography-guided PCI group

ACTIVE COMPARATOR

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

Diagnostic Test: Coronary angiography

Concurrent OCT/FFR-guided PCI group

EXPERIMENTAL

This group of patients are intended to undergo PCI with concurrent OCT/FFR-guidance. Procedural optimization determined by OCT and FFR assessment.

Diagnostic Test: optical coherence tomography and fractional flow reserveDiagnostic Test: Coronary angiography

Interventions

optical coherence tomography and fractional flow reserveDIAGNOSTIC_TEST

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

Concurrent OCT/FFR-guided PCI group
Coronary angiographyDIAGNOSTIC_TEST

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

Angiography-guided PCI groupConcurrent OCT/FFR-guided PCI group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than 19 years old
  • Patients undergoing coronary stent implantation for stable angina or acute coronary syndrome
  • Patients provided on informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Guro Hospital

Seoul, 08308, South Korea

RECRUITING

Related Publications (3)

  • 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.

    PMID: 31112213BACKGROUND

  • 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.

    PMID: 34882436BACKGROUND

  • 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.

    PMID: 34279606BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Tomography, Optical CoherenceCoronary Angiography

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative TechniquesCardiac Imaging TechniquesAngiographyRadiographyDiagnostic Techniques, CardiovascularHeart Function Tests

Study Officials

  • Dong Oh Kang, MD, PhD

    Korea University Guro Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Oh Kang, MD, PhD

CONTACT

82-2-2626-3184gelly9@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No blinding process, open label design
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, randomized open-label clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 28, 2023

First Posted

December 27, 2023

Study Start

November 30, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

December 27, 2023

Record last verified: 2023-12

Locations

KR(1)