Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03820492

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

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2023-02-09

104

Participants Needed

13

Research Sites

396 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Unprotected left main lesion with 30% to 80% angiographic diameter stenosis by visual estimation or equivocal disease by angiography
  • Age 18 years or older
  • Ability to give preliminary oral consent witnessed by an independent physician or sign written informed consent before study procedures
Not Eligible

You will not qualify if you...

  • Significant narrowing over 50% in the left anterior descending or left circumflex artery except at the ostium or side branches
  • Ostial left main disease
  • Acute coronary syndrome including non-ST-elevation ACS and ST-elevation myocardial infarction
  • Left main in-stent restenosis
  • Previous coronary stenting of the left coronary system
  • Chronic total occlusion
  • Previous coronary artery bypass graft
  • Previous myocardial infarction related to the left coronary artery
  • Ventricularization or hypotension during left main ostial engagement
  • Hemodynamic instability
  • Known renal insufficiency (serum creatinine >1.5 mg/dL or on dialysis)
  • Female of childbearing potential under 50 years without tubal ligation, ovariectomy, or hysterectomy
  • Life expectancy less than 1 year
  • Allergy or contraindication to required medications including heparin, iodinated contrast, beta-blockers, nitroglycerin, or adenosine
  • Body mass index over 35 kg/m2
  • Complex congenital heart disease other than anomalous coronary origins
  • Ventricular septal defect

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 13 locations

1

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, France, 63000

Actively Recruiting

2

Institute Mutualiste Montsouris

Paris, France, 75014

Actively Recruiting

3

Centre Cardiologique du Nord

Saint-Denis, France, 75014

Actively Recruiting

4

Universitätsklinikum Giessen Justus-Liebig Universität

Giessen, Hesse, Germany, 35392

Actively Recruiting

5

Friedrich Alexander Universität (FAU) , Medizinische Klinik 2 , Kardiologie und Angiologie

Erlangen, Germany, 91054

Actively Recruiting

6

Ageo Central General Hospital

Ageo, Japan, 362-8588

Actively Recruiting

7

Gifu heart center

Gifu, Japan, 500-8384

Actively Recruiting

8

Department of Cardiovascular Medicine Shinshu University School of Medicine

Nagano, Japan, 390-8621

Actively Recruiting

9

Kansai Medical University,

Osaka, Japan, 573-1010

Actively Recruiting

10

Medical Corporation Ouyuukai Tokorozawa Heart Center

Saitama, Japan, 359-1142

Actively Recruiting

11

Sapporo Higashi Tokushukai Hospital

Sapporo, Japan, 065-0033

Actively Recruiting

12

Inselspital

Bern, Switzerland, 3010

Actively Recruiting

13

CHUV

Lausanne, Switzerland, 1011

Actively Recruiting

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Research Team

L

Lorenz Raeber, Prof. MD PhD

CONTACT

H

Hiroki Shinutani, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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