Informations générales (source: ClinicalTrials.gov)
Multimodality Assessment of Intermediate Left Main Stenosis: Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT (OPTICO-LM)
Interventional
N/A
Insel Gruppe AG, University Hospital Bern (Voir sur ClinicalTrials)
mai 2019
décembre 2026
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CENTRE CARDIOLOGIQUE DU NORD | Franck Digne, Dr. med | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Universitaire de Clermont-Ferrand - 63000 - Clermont-Ferrand - France | Géraud Souteyrand, Prof. | Contact (sur clinicalTrials) | |||
| Institute Mutualiste Montsouris - 75014 - Paris - France | Nicolas Amabile, Dr. med. | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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.