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NCT Number: NCT03820492

Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT

Significant left main (LM) stenosis is associated with a poor prognosis, therefore, adequate judgement of the prognostic significance of LM stenosis is essential to improve patients' prognosis. Recently, fractional flow reserve (FFR) has become widespread practice and carries a Class Ia recommendation to assess functional significance of intermediate coronary stenosis in patients with stable angina. Intravascular ultrasound (IVUS)-derived minimum lumen area (MLA) represents an accurate measure to determine LM significance as shown in multiple studies, while optical coherence tomography (OCT) ,which is a novel intracoronary imaging method with a greater spatial resolution (15μm vs. 100μm), faster image acquisition and facilitated image interpretation, OCT derived-MLA has never been validated against FFR and accordingly, it is not mentioned in the current guidelines for myocardial revascularization. Coronary computed tomography angiography (CTA) has emerged as a noninvasive alternative of coronary angiography with its excellent negative predictive value, while the positive predictive value of CTA is limited. Computational fluid dynamics is an emerging method that enables prediction of blood flow in coronary arteries and calculation of FFR from computed tomography (FFRCT) noninvasively. Noninvasive and accurate assessment of functional significance would bring a great benefit for patients with LM stenosis, however, there are no data to evaluate the diagnostic accuracy of FFRCT for LM stenosis in comparison with FFR and minimal lumen area derived by OCT.

This study will investigate the optimal OCT-derived MLA cut-off point and the diagnostic performance of FFRCT for intermediate LM stenosis compared with FFR ≤0.8 as a reference standard.

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Key information

Conditions

Coronary Stenosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Unprotected LM lesion [midshaft, and distal bifurcation (Medina 1,1,1 or 1,1,0 or 1,0,1 or 1,0,0)] of 30% to 80% angiographic diameter stenosis (DS) on visual estimation or equivocal disease by angiography.
  • Age ≥18 years.
  • Ability to give preliminary oral consent witnessed by an independent physician or sign written informed consent prior to any study-specific procedures.

Exclusion criteria

  • Significant distal lesions (>50% angiographic DS on visual estimation within the left anterior descending artery [LAD] or left circumflex artery [LCX], except for ostium of LAD or LCX or diseased side branch [e.g. diagonal branch, obtuse marginal branch])
  • Ostial LM disease.
  • Acute coronary syndrome (ACS) (non-ST-elevation ACS and ST-elevation MI).
  • LM In-stent restenosis.
  • Previous coronary stenting of the left coronary system.
  • Chronic total occlusion.
  • Previous coronary artery bypass graft.
  • Previous MI related to the left coronary artery.
  • Occurrence of ventricularization or hypotension during engagement of the LM ostial lesion.
  • The presence of hemodynamic instability.
  • Known renal insufficiency (serum creatinine >1.5mg/dL or receiving dialysis).
  • Female of childbearing potential (age <50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
  • Life expectancy less than 1 year.
  • Contraindication or known allergy against protocol-required medications including heparin, iodinated contrast, β-blocker, nitroglycerin, and adenosine.
  • Body mass index >35kg/m2.
  • Complex congenital heart disease other than anomalous coronary origins alone.
  • Ventricular septal defect.

Treatment and study plan

OCT, FFR, CTA and FFRCT

Diagnostic Test

Multimodality assessment of intermediate left main stenosis: Comparison of optical coherence tomography-derived minimal lumen area, invasive fractional flow reserve and FFRCT

Primary outcomes

  1. OCT vs. FFR

    Time frame: Measurement at Procedure/ Baseline Visit

    • The area under the curve of OCT-derived MLA for FFR≤0.8

  2. OCT vs. FFR

    Time frame: Measurement at Procedure/ Baseline Visit

    -The optimal cut-off point of OCT-derived MLA from receiver-operator characteristics curves for FFR≤0.8

  3. FFRCT vs. FFR

    Time frame: Measurement at Procedure/ Baseline Visit

    Diagnostic accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of FFRCT≤0.8 for FFR≤0.8

Secondary outcomes

  1. OCT vs. FFR, RFR, resting Pd/Pa, FFRCT, QFR

    Time frame: Measurement at Procedure/ Baseline Visit

    • The area under the curve and the optimal cut-off point of OCT-derived MLA from receiver-operator characteristics curves for FFR≤0.75, RFR≤0.89, resting Pd/Pa≤0.91, and FFRCT≤0.80 and QFR≤0.80

  2. OCT vs. FFR, RFR, resting Pd/Pa, FFRCT

    Time frame: Measurement at Procedure/ Baseline Visit

    • Predictability of MLA, minimal lumen diameter, area stenosis, lesion length, eccentricity index, and plaque characteristics (plaque rupture, fibroatheroma, and calcification) for FFR ≤0.8, FFR≤0.75, RFR≤0.89, resting Pd/Pa≤0.91, and FFRCT≤0.80 and QFR≤0.80

  3. OCT vs. FFR, RFR, resting Pd/Pa, FFRCT

    Time frame: Measurement at Procedure/ Baseline Visit

    • Correlation among OCT-derived MLA, FFR, RFR, resting Pd/Pa, and FFRCT and QFR

  4. OCT vs. CTA

    Time frame: Measurement at Procedure/ Baseline Visit

    • Correlation between luminal diameter stenosis of CTA and OCT-derived MLA

  5. OCT vs. CTA

    Time frame: Measurement at Procedure/ Baseline Visit

    • Diagnostic accuracy of plaque characteristics with presumed high risk characteristics including napkin ring sign, low attenuation plaque (<30HU), positive remodelling (remodelling index >1.1), and spotty calcium (<3mm) for thin and thick cap fibroatheroma by OCT.

  6. Clinical endpoint at 1 year

    Time frame: 12 Month

    Death

  7. Clinical endpoint at 1 year

    Time frame: 12 Month

    Myocardial infarction

  8. Clinical endpoint at 1 year

    Time frame: 12 Month

    Target vessel myocardial infarction

  9. Clinical endpoint at 1 year

    Time frame: 12 Month

    Target lesion revascularization

  10. Clinical endpoint at 1 year

    Time frame: 12 Month

    Target vessel revascularization

  11. Clinical endpoint at 1 year

    Time frame: 12 Month

    Any revascularization

  12. Clinical endpoint at 1 year

    Time frame: 12 Month

    Stent thrombosis

  13. Clinical endpoint at 1 year

    Time frame: 12 Month

    Stroke and transient ischemic attack

  14. Clinical endpoint at 1 year

    Time frame: 12 Month

    Acute renal failure

Study contacts

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

Hiroki Shinutani, MD

CONTACT

[email protected]

+41316322111

Lorenz Raeber, Prof. MD PhD

CONTACT

[email protected]

+41316322111

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Multimodality Assessment of Intermediate Left Main Stenosis: Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT

Acronym: OPTICO-LM

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2019
Registry last updated
Feb 9, 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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