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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03820492
Other study ID # OPTICO-LM
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 28, 2019
Est. completion date December 31, 2026

Study information

Verified date February 2023
Source University Hospital Inselspital, Berne
Contact Lorenz Raeber, Prof. MD PhD
Phone +41316322111
Email lorenz.raeber@insel.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 104
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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, ß-blocker, nitroglycerin, and adenosine. - Body mass index >35kg/m2. - Complex congenital heart disease other than anomalous coronary origins alone. - Ventricular septal defect.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
OCT, FFR, CTA and FFRCT
Multimodality assessment of intermediate left main stenosis: Comparison of optical coherence tomography-derived minimal lumen area, invasive fractional flow reserve and FFRCT

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Countries where clinical trial is conducted

France,  Germany,  Japan,  Switzerland, 

References & Publications (5)

de la Torre Hernandez JM, Hernandez Hernandez F, Alfonso F, Rumoroso JR, Lopez-Palop R, Sadaba M, Carrillo P, Rondan J, Lozano I, Ruiz Nodar JM, Baz JA, Fernandez Nofrerias E, Pajin F, Garcia Camarero T, Gutierrez H; LITRO Study Group (Spanish Working Group on Interventional Cardiology). Prospective application of pre-defined intravascular ultrasound criteria for assessment of intermediate left main coronary artery lesions results from the multicenter LITRO study. J Am Coll Cardiol. 2011 Jul 19;58(4):351-8. doi: 10.1016/j.jacc.2011.02.064. — View Citation

Jasti V, Ivan E, Yalamanchili V, Wongpraparut N, Leesar MA. Correlations between fractional flow reserve and intravascular ultrasound in patients with an ambiguous left main coronary artery stenosis. Circulation. 2004 Nov 2;110(18):2831-6. doi: 10.1161/01.CIR.0000146338.62813.E7. Epub 2004 Oct 18. — View Citation

Makikallio T, Holm NR, Lindsay M, Spence MS, Erglis A, Menown IB, Trovik T, Eskola M, Romppanen H, Kellerth T, Ravkilde J, Jensen LO, Kalinauskas G, Linder RB, Pentikainen M, Hervold A, Banning A, Zaman A, Cotton J, Eriksen E, Margus S, Sorensen HT, Nielsen PH, Niemela M, Kervinen K, Lassen JF, Maeng M, Oldroyd K, Berg G, Walsh SJ, Hanratty CG, Kumsars I, Stradins P, Steigen TK, Frobert O, Graham AN, Endresen PC, Corbascio M, Kajander O, Trivedi U, Hartikainen J, Anttila V, Hildick-Smith D, Thuesen L, Christiansen EH; NOBLE study investigators. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial. Lancet. 2016 Dec 3;388(10061):2743-2752. doi: 10.1016/S0140-6736(16)32052-9. Epub 2016 Oct 31. Erratum In: Lancet. 2016 Dec 3;388(10061):2742. — View Citation

Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available. Erratum In: Eur Heart J. 2019 Oct 1;40(37):3096. — View Citation

Norgaard BL, Leipsic J, Gaur S, Seneviratne S, Ko BS, Ito H, Jensen JM, Mauri L, De Bruyne B, Bezerra H, Osawa K, Marwan M, Naber C, Erglis A, Park SJ, Christiansen EH, Kaltoft A, Lassen JF, Botker HE, Achenbach S; NXT Trial Study Group. Diagnostic performance of noninvasive fractional flow reserve derived from coronary computed tomography angiography in suspected coronary artery disease: the NXT trial (Analysis of Coronary Blood Flow Using CT Angiography: Next Steps). J Am Coll Cardiol. 2014 Apr 1;63(12):1145-1155. doi: 10.1016/j.jacc.2013.11.043. Epub 2014 Jan 30. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary OCT vs. FFR - The area under the curve of OCT-derived MLA for FFR=0.8 Measurement at Procedure/ Baseline Visit
Primary OCT vs. FFR -The optimal cut-off point of OCT-derived MLA from receiver-operator characteristics curves for FFR=0.8 Measurement at Procedure/ Baseline Visit
Primary FFRCT vs. FFR Diagnostic accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of FFRCT=0.8 for FFR=0.8 Measurement at Procedure/ Baseline Visit
Secondary OCT vs. FFR, RFR, resting Pd/Pa, FFRCT, QFR - The area under the curve and the optimal cut-off point of OCT-derived MLA from receiver-operator characteristics curves for FFR=0.75, RFR=0.89, resting Pd/Pa=0.91, and FFRCT=0.80 and QFR=0.80 Measurement at Procedure/ Baseline Visit
Secondary OCT vs. FFR, RFR, resting Pd/Pa, FFRCT - Predictability of MLA, minimal lumen diameter, area stenosis, lesion length, eccentricity index, and plaque characteristics (plaque rupture, fibroatheroma, and calcification) for FFR =0.8, FFR=0.75, RFR=0.89, resting Pd/Pa=0.91, and FFRCT=0.80 and QFR=0.80 Measurement at Procedure/ Baseline Visit
Secondary OCT vs. FFR, RFR, resting Pd/Pa, FFRCT - Correlation among OCT-derived MLA, FFR, RFR, resting Pd/Pa, and FFRCT and QFR Measurement at Procedure/ Baseline Visit
Secondary OCT vs. CTA - Correlation between luminal diameter stenosis of CTA and OCT-derived MLA Measurement at Procedure/ Baseline Visit
Secondary OCT vs. CTA - Diagnostic accuracy of plaque characteristics with presumed high risk characteristics including napkin ring sign, low attenuation plaque (<30HU), positive remodelling (remodelling index >1.1), and spotty calcium (<3mm) for thin and thick cap fibroatheroma by OCT. Measurement at Procedure/ Baseline Visit
Secondary Clinical endpoint at 1 year Death 12 Month
Secondary Clinical endpoint at 1 year Myocardial infarction 12 Month
Secondary Clinical endpoint at 1 year Target vessel myocardial infarction 12 Month
Secondary Clinical endpoint at 1 year Target lesion revascularization 12 Month
Secondary Clinical endpoint at 1 year Target vessel revascularization 12 Month
Secondary Clinical endpoint at 1 year Any revascularization 12 Month
Secondary Clinical endpoint at 1 year Stent thrombosis 12 Month
Secondary Clinical endpoint at 1 year Stroke and transient ischemic attack 12 Month
Secondary Clinical endpoint at 1 year Acute renal failure 12 Month
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