Actively Recruiting
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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
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
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here