Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT
NCT ID: NCT03820492
Last Updated: 2023-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
104 participants
INTERVENTIONAL
2019-05-28
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Lorenz Raeber, Prof. MD PhD
Role: PRINCIPAL_INVESTIGATOR
Inselspital
Locations
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Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, , France
Institute Mutualiste Montsouris
Paris, , France
Centre Cardiologique du Nord
Saint-Denis, , France
Universitätsklinikum Giessen Justus-Liebig Universität
Giessen, Hesse, Germany
Friedrich Alexander Universität (FAU) , Medizinische Klinik 2 , Kardiologie und Angiologie
Erlangen, , Germany
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, , Japan
Inselspital
Bern, , Switzerland
CHUV
Lausanne, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Masataka Nakano, Dr. med
Role: primary
Kenichi Fuji, Dr.med
Role: primary
Stephane Fournier, MD
Role: primary
References
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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.
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.
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.
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.
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.
Other Identifiers
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OPTICO-LM
Identifier Type: -
Identifier Source: org_study_id
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