Comparing imaging techniques for assessing coronary artery disease
Multimodality Assessment of Intermediate Left Main Stenosis: Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT
This study is testing if a new imaging technique called optical coherence tomography can better measure blockages in heart arteries compared to traditional methods for patients with certain heart conditions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 13 sites (Clermont-Ferrand and 12 other locations) |
| Trial ID | NCT03820492 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of optical coherence tomography (OCT) in measuring the minimal lumen area (MLA) of significant left main coronary stenosis compared to traditional methods like fractional flow reserve (FFR) and computed tomography angiography (CTA). It aims to determine if OCT-derived MLA can provide accurate prognostic information for patients with intermediate coronary stenosis. The study includes patients with specific angiographic criteria and will assess the correlation between these imaging techniques and their implications for patient management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with unprotected left main lesions showing 30% to 80% angiographic diameter stenosis.
Not a fit: Patients with significant distal lesions, acute coronary syndrome, or previous coronary interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing and managing coronary artery disease, leading to better patient outcomes.
How similar studies have performed: Previous studies have shown success with FFR and IVUS, but the use of OCT-derived MLA in this context is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 this trial is running
Clermont-Ferrand and 12 other locations
- Centre Hospitalier Universitaire de Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
- Institute Mutualiste Montsouris — Paris, France (Recruiting)
- Centre Cardiologique du Nord — Saint-Denis, France (Recruiting)
- Universitätsklinikum Giessen Justus-Liebig Universität — Giessen, Hesse, Germany (Recruiting)
- Friedrich Alexander Universität (FAU) , Medizinische Klinik 2 , Kardiologie und Angiologie — Erlangen, Germany (Recruiting)
- Ageo Central General Hospital — Ageo, Japan (Recruiting)
- Gifu heart center — Gifu, Japan (Recruiting)
- Department of Cardiovascular Medicine Shinshu University School of Medicine — Nagano, Japan (Recruiting)
- Kansai Medical University, — Osaka, Japan (Recruiting)
- Medical Corporation Ouyuukai Tokorozawa Heart Center — Saitama, Japan (Recruiting)
- Sapporo Higashi Tokushukai Hospital — Sapporo, Japan (Recruiting)
- Inselspital — Bern, Switzerland (Recruiting)
- Chuv — Lausanne, Switzerland (Recruiting)
Study contacts
- Principal investigator: Lorenz Raeber, Prof. MD PhD — Inselspital
- Study coordinator: Lorenz Raeber, Prof. MD PhD
- Email: lorenz.raeber@insel.ch
- Phone: +41316322111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.