Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional
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 functio
| Condition(s) | Coronary Stenosis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 validate |
| Who can participate | 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. Exclusion Criteria: * 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 re |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Insel Gruppe AG, University Hospital Bern |
| Locations | Clermont-Ferrand, France; Paris, France; Saint-Denis, France; Giessen, Hesse, Germany; Erlangen, Germany; Ageo, Japan (+7 more sites) |
| Start date | 2019-05-28 |
| NCT ID | NCT03820492 |
| Official listing | https://clinicaltrials.gov/study/NCT03820492 |