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Coronary StenosisOPTICO-LMNCT03820492

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

A study testing OCT, FFR, CTA and FFRCT in people with Coronary Stenosis, run by Insel Gruppe AG, University Hospital Bern at 13 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Stenosis
What is being tested?
OCT, FFR, CTA and FFRCT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
13 sitesin 4 countries
Study dates
28 May 2019to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

13 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Lorenz Raeber, Prof. MD PhD contact

+41316322111

lorenz.raeber@insel.ch

Hiroki Shinutani, MD contact

+41316322111

hiroki.shibutani@extern.insel.ch

13 sites in 4 countries

Japan6 sites, 6 recruiting

  • Ageo Central General Hospital

    Ageo, 362-8588

    Masataka Nakano, Dr. med

    Recruiting

  • Gifu heart center

    Gifu, 500-8384

    Matsuo Hitoshi, Dr., 58-277-2277 ext. +81, matsuo@heart-center.or.jp

    Recruiting

  • Department of Cardiovascular Medicine Shinshu University School of Medicine

    Nagano, 390-8621

    Yasushi Ueki, Dr. med. PhD, yasushi522@shinshu-u.ac.jp

    Recruiting

  • Kansai Medical University,

    Osaka, 573-1010

    Kenichi Fuji, Dr.med

    Recruiting

  • Medical Corporation Ouyuukai Tokorozawa Heart Center

    Saitama, 359-1142

    Taniwaki Masanori, Dr., 4 2940 8611 ext. +81, grand_wagoneer_797@hotmail.com

    Recruiting

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, 065-0033

    Yuki Katagiri, Dr. med, ykatagiri.ggl@gmail.com

    Recruiting

Other trials in Japan

France3 sites, 3 recruiting

  • Centre Hospitalier Universitaire de Clermont-Ferrand

    Clermont-Ferrand, 63000

    Géraud Souteyrand, Prof., gsouteyrand@chu-clermontferrand.fr

    Recruiting

  • Institute Mutualiste Montsouris

    Paris, 75014

    Nicolas Amabile, Dr. med., nicolasamabile@yahoo.fr

    Recruiting

  • Centre Cardiologique du Nord

    Saint-Denis, 75014

    Franck Digne, Dr. med, f.digne@ccn.fr

    Recruiting

Other trials in France

Germany2 sites, 2 recruiting

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

    Erlangen, 91054

    Stephan Achenbach, Prof., Stephan.Achenbach@uk-erlangen.de

    Recruiting

  • Universitätsklinikum Giessen Justus-Liebig Universität

    Giessen, Hesse, 35392

    Nef Holger, Professor, 641 98556220 ext. +49, Holger.Nef@innere.med.uni-giessen.de

    Recruiting

Other trials in Germany

Switzerland2 sites, 2 recruiting

  • Inselspital

    Bern, 3010

    Lorenz Räber, Prof MD, +41 31 632 09 29, lorenz.raeber@insel.ch

    Recruiting

  • CHUV

    Lausanne, 1011

    Stephane Fournier, MD

    Recruiting

Other trials in Switzerland

About this study

Official title: Multimodality Assessment of Intermediate Left Main Stenosis: Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT

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.

Being tested
OCT, FFR, CTA and FFRCT
Keywords
Coronary artery disease, Fractional flow reserve, Optical coherence tomography, Computed tomography angiography
Medical subject headings
Coronary Stenosis, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OCT, FFR, CTA and FFRCTDiagnostic test

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

Study groups in NCT03820492
Study groupRoleWhat they receive
Patient with left-main stenosisOtherMultimodality assessment of intermediate left main stenosis: Comparison of optical coherence tomography-derived minimal lumen area, invasive fractional flow reserve and FFRCT
Receives: Diagnostic Test: OCT, FFR, CTA and FFRCT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. OCT vs. FFR

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

    Measured: Measurement at Procedure/ Baseline Visit

  2. OCT vs. FFR

    -The optimal cut-off point of OCT-derived MLA from receiver-operator characteristics curves for FFR≤0.8

    Measured: Measurement at Procedure/ Baseline Visit

  3. FFRCT vs. FFR

    Diagnostic accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of FFRCT≤0.8 for FFR≤0.8

    Measured: Measurement at Procedure/ Baseline Visit

Secondary outcomes (14)

  1. 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

    Measured: Measurement at Procedure/ Baseline Visit

  2. 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

    Measured: Measurement at Procedure/ Baseline Visit

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

    • Correlation among OCT-derived MLA, FFR, RFR, resting Pd/Pa, and FFRCT and QFR

    Measured: Measurement at Procedure/ Baseline Visit

  4. OCT vs. CTA

    • Correlation between luminal diameter stenosis of CTA and OCT-derived MLA

    Measured: Measurement at Procedure/ Baseline Visit

  5. 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.

    Measured: Measurement at Procedure/ Baseline Visit

  6. Clinical endpoint at 1 year

    Death

    Measured: 12 Month

  7. Clinical endpoint at 1 year

    Myocardial infarction

    Measured: 12 Month

  8. Clinical endpoint at 1 year

    Target vessel myocardial infarction

    Measured: 12 Month

  9. Clinical endpoint at 1 year

    Target lesion revascularization

    Measured: 12 Month

  10. Clinical endpoint at 1 year

    Target vessel revascularization

    Measured: 12 Month

  11. Clinical endpoint at 1 year

    Any revascularization

    Measured: 12 Month

  12. Clinical endpoint at 1 year

    Stent thrombosis

    Measured: 12 Month

  13. Clinical endpoint at 1 year

    Stroke and transient ischemic attack

    Measured: 12 Month

  14. Clinical endpoint at 1 year

    Acute renal failure

    Measured: 12 Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2019
  2. Study start28 May 2019
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
104 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03820492
Sponsor's protocol ID
OPTICO-LM
Acronym
OPTICO-LM
Status last verified
Feb 2023
First submitted
17 Jan 2019
Last updated
9 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27810312

  • 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.

    PubMed 30165437

  • 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.

    PubMed 15492302

  • 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.

    PubMed 21757111

  • 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.

    PubMed 24486266

Questions about this trial

What is this clinical trial studying?

A study testing OCT, FFR, CTA and FFRCT in people with Coronary Stenosis, run by Insel Gruppe AG, University Hospital Bern at 13 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Japan, France, Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lorenz Raeber, Prof. MD PhD (+41316322111, lorenz.raeber@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OCT vs. FFR (time frame: Measurement at Procedure/ Baseline Visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03820492, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.

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