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

Recruiting now · Not applicable

Conditions studied: Coronary Stenosis

In brief

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.

Key facts

Study ID

NCT03820492

Run by

Insel Gruppe AG, University Hospital Bern

People needed

104

Starts

2019-05-28

Expected to finish

2026-12-31

Last updated by the study team

2023-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Centre Hospitalier Universitaire de Clermont-Ferrand — Clermont-Ferrand, France (enrolling)
• Institute Mutualiste Montsouris — Paris, France (enrolling)
• Centre Cardiologique du Nord — Saint-Denis, France (enrolling)
• Universitätsklinikum Giessen Justus-Liebig Universität — Giessen, Hesse, Germany (enrolling)
• Friedrich Alexander Universität (FAU) , Medizinische Klinik 2 , Kardiologie und Angiologie — Erlangen, Germany (enrolling)
• Ageo Central General Hospital — Ageo, Japan (enrolling)
• Gifu heart center — Gifu, Japan (enrolling)
• Department of Cardiovascular Medicine Shinshu University School of Medicine — Nagano, Japan (enrolling)
• Kansai Medical University, — Osaka, Japan (enrolling)
• Medical Corporation Ouyuukai Tokorozawa Heart Center — Saitama, Japan (enrolling)
• Sapporo Higashi Tokushukai Hospital — Sapporo, Japan (enrolling)
• Inselspital — Bern, Switzerland (enrolling)
• CHUV — Lausanne, Switzerland (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.