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

NCT03820492 | Recruiting DMC

• 1 other identifier: OPTICO-LM
• Study Type: interventional
• Target: 104
• Locations: 4 countries
• Sites: 13

Brief 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.

Conditions

Coronary Stenosis

Keywords

Coronary artery disease; Fractional flow reserve; Optical coherence tomography; Computed tomography angiography

Outcome Measures

Primary Outcomes (3)

• OCT vs. FFR

  \- The area under the curve of OCT-derived MLA for FFR≤0.8

  Measurement at Procedure/ Baseline Visit

• 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

• 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 Outcomes (14)

• OCT vs. FFR, RFR, resting Pd/Pa, FFRCT, QFR

  Measurement at Procedure/ Baseline Visit

• OCT vs. FFR, RFR, resting Pd/Pa, FFRCT

  Measurement at Procedure/ Baseline Visit

• OCT vs. FFR, RFR, resting Pd/Pa, FFRCT

  Measurement at Procedure/ Baseline Visit

• OCT vs. CTA

  Measurement at Procedure/ Baseline Visit

• OCT vs. CTA

  Measurement at Procedure/ Baseline Visit

Study Arms (1)

Patient with left-main stenosis

OTHER

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

Diagnostic Test: OCT, FFR, CTA and FFRCT

Interventions

OCT, FFR, CTA and FFRCT DIAGNOSTIC_TEST

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

Patient with left-main stenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (13)

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

Institute Mutualiste Montsouris

Paris, 75014, France

RECRUITING

Centre Cardiologique du Nord

Saint-Denis, 75014, France

RECRUITING

Universitätsklinikum Giessen Justus-Liebig Universität

Giessen, Hesse, 35392, Germany

RECRUITING

Friedrich Alexander Universität (FAU) , Medizinische Klinik 2 , Kardiologie und Angiologie

Erlangen, 91054, Germany

RECRUITING

Ageo Central General Hospital

Ageo, 362-8588, Japan

RECRUITING

Gifu heart center

Gifu, 500-8384, Japan

RECRUITING

Department of Cardiovascular Medicine Shinshu University School of Medicine

Nagano, 390-8621, Japan

RECRUITING

Kansai Medical University,

Osaka, 573-1010, Japan

RECRUITING

Medical Corporation Ouyuukai Tokorozawa Heart Center

Saitama, 359-1142, Japan

RECRUITING

Sapporo Higashi Tokushukai Hospital

Sapporo, 065-0033, Japan

RECRUITING

Inselspital

Bern, 3010, Switzerland

RECRUITING

CHUV

Lausanne, 1011, Switzerland

RECRUITING

Related Publications (5)

• 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.

  PMID: 27810312 BACKGROUND

• 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.

  PMID: 30165437 BACKGROUND

• 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.

  PMID: 15492302 BACKGROUND

• 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.

  PMID: 21757111 BACKGROUND

• 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.

  PMID: 24486266 BACKGROUND

MeSH Terms

Conditions

Coronary Stenosis; Coronary Artery Disease

Interventions

Tomography, Optical Coherence; Computed Tomography Angiography

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques; Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray

Study Officials

• Lorenz Raeber, Prof. MD PhD

  Inselspital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenz Raeber, Prof. MD PhD

CONTACT

+41316322111; lorenz.raeber@insel.ch

Hiroki Shinutani, MD

CONTACT

+41316322111; hiroki.shibutani@extern.insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 29, 2019
• Study Start: May 28, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3); JP (6); DE (2); CH (2)