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NCT Number: NCT06182683

Concurrent OCT and FFR-guided PCI in 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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atheroscleroses, Coronary Cardiovascular Diseases Coronary Disease Heart Diseases Image Myocardial Ischemia Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location status: Recruiting

Location contact

Dong Oh Kang, MD, PhD

CONTACT

[email protected]

+82-2-2626-3184

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

optical coherence tomography and fractional flow reserve

Diagnostic Test

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

Coronary angiography

Diagnostic Test

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

Primary outcomes

  1. Rate of target vessel failure (TVF)

    Time frame: 1-year

    a composite endpoint of cardiac death, target vessel-related non-fatal myocardial infarction, clinically driven-target vessel revascularization

Secondary outcomes

  1. Rate of all-cause mortality

    Time frame: 1-year

    cardiac and non-cardiac death

  2. Rate of any myocardial infarction (MI)

    Time frame: 1-year

    myocardial infarction due to target vessel and non-target vessel failure

  3. Rate of clinically-driven target vessel revascularization (TVR)

    Time frame: 1-year

    clinically-driven target vessel revascularization

  4. Rate of any revascularization

    Time frame: 1-year

    clinically-driven target lesion and non-target lesion revascularization

  5. Rate of stent thrombosis (acute, subacute, late, very late)

    Time frame: 1-year

    stent thrombosis based on presenting time after the index procedure

  6. Rate of BARC-defined bleeding

    Time frame: 1-year

    clinically-relevant bleeding event based on BARC classification

Other outcomes

  1. FFR optimization rate

    Time frame: Immediately after index procedure

    • 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

  2. OCT optimization rate

    Time frame: Immediately after index procedure

    • Post-PCI MSA ≥ 4.5 mm2, and 2) Post-PCI expansion ≥ 80%

Study contacts

Contact information is provided by the study sponsor or research team.

Dong Oh Kang, MD, PhD

CONTACT

[email protected]

82-2-2626-3184

Sponsors and collaborators

Lead sponsor

Korea University Guro Hospital

Other

Registry information

Official study title

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

Acronym: OPTICARE-CAD

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Dec 27, 2023
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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