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

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Centre Hospitalier Universitaire de Clermont-Ferrand
RECRUITING
Clermont-ferrand
Institute Mutualiste Montsouris
RECRUITING
Paris
Centre Cardiologique du Nord
RECRUITING
Saint-denis
Germany
Friedrich Alexander Universität (FAU) , Medizinische Klinik 2 , Kardiologie und Angiologie
RECRUITING
Erlangen
Universitätsklinikum Giessen Justus-Liebig Universität
RECRUITING
Giessen
Japan
Ageo Central General Hospital
RECRUITING
Ageo
Gifu heart center
RECRUITING
Gifu
Department of Cardiovascular Medicine Shinshu University School of Medicine
RECRUITING
Nagano
Kansai Medical University,
RECRUITING
Osaka
Medical Corporation Ouyuukai Tokorozawa Heart Center
RECRUITING
Saitama
Sapporo Higashi Tokushukai Hospital
RECRUITING
Sapporo
Switzerland
Inselspital
RECRUITING
Bern
CHUV
RECRUITING
Lausanne
Contact Information
Primary
Lorenz Raeber, Prof. MD PhD
lorenz.raeber@insel.ch
+41316322111
Backup
Hiroki Shinutani, MD
hiroki.shibutani@extern.insel.ch
+41316322111
Time Frame
Start Date: 2019-05-28
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 104
Treatments
Other: Patient with left-main stenosis
Multimodality assessment of intermediate left main stenosis: Comparison of optical coherence tomography-derived minimal lumen area, invasive fractional flow reserve and FFRCT
Sponsors
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov