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Coronary Artery DiseaseiLITRONCT03767621

Concordance Between FFR and iFR for the Assessment of Intermediate Lesions in the Left Main Coronary Artery. A Prospective Validation of a Default Value for iFR

An observational study of Coronary Artery Disease and Left Main Coronary Artery Stenosis, run by Fundación EPIC at 38 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The assessment of Left Main Coronary Artery (LMCA) lesions by means of coronary angiography renders serious limitations. Studies with a limited number of patients have shown that a value of FFR (Fractional Flow Reserve) above 0.80 identify a low risk of events in case of not performing revascularization in patients… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Indication of revascularization
How many people
300 participants
Where
38 sitesSpain
Study dates
19 Feb 2019to 30 Nov 2026
How long will I take part?
5 Years
Phase
Observational
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

Study population: Patients with intermediate stenosis of the LMCA will be included by coronary angiography (estimate visual 25-60%) in which a functional study is performed with pressure and calculation guidance of iFR and FFR with intravenous adenosine in perfusion to guide the indication of revascularization.

Who may be able to join

  • Patients with intermediate lesion in the LMCA (25-60% angiographic stenosis) by visual estimation) in which the realization of a study with guide of pressure for the determination of the iFR.
  • Patients aged ≥18 years.
  • Patients able of giving informed consent.

Who cannot join

  • Patients with indication for coronary surgery regardless of the significance of the LMCA lesion.
  • Patients with a LMCA lesion presenting with ulceration, dissection or thrombus.
  • Patients with previous arterial or venous graft lesion functioning in the territory irrigated by the LMCA (LMCA protected).
  • Patients with ACS (Acute Coronary Syndrome) with a potentially guilty lesion in the LMCA.
  • Patients unable to obtain informed consent.
  • Patients with known terminal illness that conditions a life expectancy less than 1 year.
  • Patients with hemodynamic instability with Killip III or IV class.

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

Spain38 sites

  • Hospital General Universitario de Albacete

    Albacete, 02006

  • Hospital Universitario de Badajoz

    Badajoz, 06080

  • Hospital Universitari Germans Trias I Pujol de Badalona

    Badalona, 08916

  • Hospital Del Mar

    Barcelona, 08003

  • Hospital Clinic I Provincial de Barcelona

    Barcelona, 08028

  • Hospital Universitari Vall D'Hebron

    Barcelona, 08035

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041

  • Hospital Universitari Bellvitge

    Barcelona, 08908

  • Hospital Universitario Puerto Real

    Cadiz, 11510

  • Hospital General Universitario de Santa Lucia de Cartagena

    Cartagena, Murcia, 30202

  • Hospital General Universitario de Castellón

    Castellon, Valencia, 12004

  • Hospital General de Ciudad Real

    Ciudad Real, 13005

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Clinico Universitario Virgen de La Arrixaca

    El Palmar, Murcia, 30120

  • Hospital Galdakao-Usansolo

    Galdakao, Vizcaya, 48960

  • Hospital Universitario de Cabueñes

    Gijón, 33203

  • Hospital Universitari Doctor Josep Trueta

    Girona, 17007

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18014

  • Hospital General Juan Ramón Jiménez

    Huelva, 21005

  • Hospital de León

    León, 24080

  • Hospital Universitari Lucus Agusti

    Lugo, 27003

  • Hospital de La Princesa

    Madrid, 28006

  • Clinica Universitaria de Navarra

    Madrid, 28027

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario de La Paz

    Madrid, 28046

  • Hospital Universitario Virgen de La Victoria

    Málaga, 29010

  • Hospital de Merida

    Mérida, 06800

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Hospital Universitario de Donostia

    San Sebastián, 20014

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Hospital Clinico Universitario de Santiago de Compostela

    Santiago de Compostela, 15706

  • Hospital Universitari Joan Xxiii de Tarragona

    Tarragona, 43005

  • Hospital Universitari Mutua de Terrassa

    Terrassa, Barcelona, 08221

  • Hospital Universitario Virgen de La Salud

    Toledo, 45004

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitari I Politecnic La Fe

    Valencia, 46026

  • Hospital Universitario Alvaro Cunqueiro

    Vigo, 36312

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

About this study

Official title: Concordance Between FFR and iFR for the Assessment of Intermediate Lesions in the Left Main Coronary Artery. A Prospective Validation of a Default Value for iFR (iLITRO Study)

The assessment of Left Main Coronary Artery (LMCA) lesions by means of coronary angiography renders serious limitations.

Studies with a limited number of patients have shown that a value of FFR (Fractional Flow Reserve) above 0.80 identify a low risk of events in case of not performing revascularization in patients with intermediate stenosis in the LMCA. Although iFR (Instant wave Free Ratio) has recently been found equivalent to FFR The demonstration of the prognostic utility of iFR in patients with LMCA intermediate lesions could have an important clinical impact and justify its systematic use for the treatment decision in these high-risk patients.

Read the detailed description

The assessment of Left Main Coronary Artery (LMCA) lesions by means of coronary angiography renders serious limitations. In the case of intermediate stenoses (25-60%), invasive imaging tests, intravascular ultrasound (IVUS) or optical coherence tomography (OCT) or functional by determining the Fractional Flow Reserve (FFR), have been proposed to identify those patients who could benefit from revascularization.

Studies with a limited number of patients have shown that a value of FFR above 0.80 identify a low risk of events in case of not performing revascularization in patients with intermediate stenosis in the LMCA. Although iFR (Instant wave Free Ratio) has recently been found equivalent to FFR in assessing the prognosis of patients with intermediate lesions, the validation of the prognostic power of this index in patients with intermediate LMCA lesions has not been demonstrated, although it is used in clinical practice assuming the results in other locations of the lesions.

The demonstration of the prognostic utility of iFR in patients with LMCA intermediate lesions could have an important clinical impact and justify its systematic use for the treatment decision in these high-risk patients.

Being tested
Indication of revascularization
Keywords
Left Main Coronary Artery, Intermediate Coronary Lesions, iFR, Coronary Physiology, IVUS
Medical subject headings
Coronary Artery Disease, Coronary Restenosis

What participants receive

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

  • Indication of revascularizationOther

    Device: iFR/FFR

Study groups in NCT03767621
Study groupRoleWhat they receive
Patients with intermediate lesions.Patients with intermediate lesions (stenosis in angiography between 25% and 60%) in LMCA.
Receives: Other: Indication of revascularization

What is being measured

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

  1. Assessment correlation between FFR>=0.80 and iFR >=0.89

    Efficacy and correlation of two invasive indexes of functional assessment by intracoronary pressure guidance in intermediate lesions of the LMCA with a cut-off point to defer the treatment of FFR> = 0.80 (with intravenous adenosine) and iFR > = 0.89. the LMCA.

    Measured: 1 day

  2. Major Adverse Cardiac Events

    Composite of death, myocardial infarction, unplanned revascularisation

    Measured: 30 days

  3. Major Adverse Cardiac Events

    Composite of death, myocardial infarction, unplanned revascularisation

    Measured: 1 year

  4. Major Adverse Cardiac Events

    Composite of death, myocardial infarction, unplanned revascularisation

    Measured: 5 years

Secondary outcomes (11)

  1. Assessment correlation between iFR and IVUS

    Assessment correlation between iFR and IVUS derived minimal luminal area

    Measured: 5 years

  2. Death (all cause)

    Death (all cause)

    Measured: 30 days, 1 and 5 years

  3. Death (cardiovascular)

    Death (cardiovascular)

    Measured: 30 days, 1 and 5 years

  4. Non-fatal Myocardial Infarction

    Non-fatal Myocardial Infarction

    Measured: 30 days, 1 and 5 years

  5. Non-fatal Myocardial Infarction related to the LMCA lesion

    Non-fatal Myocardial Infarction related to the LMCA lesion

    Measured: 30 days, 1 and 5 years

  6. Revascularization

    Revascularization

    Measured: 30 days, 1 and 5 years

  7. Revascularization of the target lesion

    Revascularization of the target lesion

    Measured: 30 days, 1 and 5 years

  8. Myocardial Infarction related to target lesion revascularization

    Myocardial Infarction related to target lesion revascularization

    Measured: 30 days, 1 and 5 years

  9. Stent Thrombosis in the target lesion revascularization

    Stent Thrombosis in the target lesion revascularization

    Measured: 30 days, 1 and 5 years

  10. Restenosis of the stent in target lesion

    Restenosis of the stent in target lesion

    Measured: 30 days, 1 and 5 years

  11. New revascularization of the target lesion

    New revascularization of the target lesion

    Measured: 30 days, 1 and 5 years

Timeline

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

  1. First posted6 Dec 2018
  2. Study start19 Feb 2019
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Nov 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
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
300 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03767621
Sponsor's protocol ID
iLITRO EPIC-07
Acronym
iLITRO
Status last verified
Mar 2025
First submitted
2 Dec 2018
Last updated
5 Mar 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • De Bruyne B, Baudhuin T, Melin JA, Pijls NH, Sys SU, Bol A, Paulus WJ, Heyndrickx GR, Wijns W. Coronary flow reserve calculated from pressure measurements in humans. Validation with positron emission tomography. Circulation. 1994 Mar;89(3):1013-22. doi: 10.1161/01.cir.89.3.1013.

    PubMed 8124786

  • Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.

    PubMed 25173339

  • Pijls NH, van Schaardenburgh P, Manoharan G, Boersma E, Bech JW, van't Veer M, Bar F, Hoorntje J, Koolen J, Wijns W, de Bruyne B. Percutaneous coronary intervention of functionally nonsignificant stenosis: 5-year follow-up of the DEFER Study. J Am Coll Cardiol. 2007 May 29;49(21):2105-11. doi: 10.1016/j.jacc.2007.01.087. Epub 2007 May 17.

    PubMed 17531660

  • Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.

    PubMed 19144937

  • Sen S, Escaned J, Malik IS, Mikhail GW, Foale RA, Mila R, Tarkin J, Petraco R, Broyd C, Jabbour R, Sethi A, Baker CS, Bellamy M, Al-Bustami M, Hackett D, Khan M, Lefroy D, Parker KH, Hughes AD, Francis DP, Di Mario C, Mayet J, Davies JE. Development and validation of a new adenosine-independent index of stenosis severity from coronary wave-intensity analysis: results of the ADVISE (ADenosine Vasodilator Independent Stenosis Evaluation) study. J Am Coll Cardiol. 2012 Apr 10;59(15):1392-402. doi: 10.1016/j.jacc.2011.11.003. Epub 2011 Dec 7.

    PubMed 22154731

  • Davies JE, Sen S, Dehbi HM, Al-Lamee R, Petraco R, Nijjer SS, Bhindi R, Lehman SJ, Walters D, Sapontis J, Janssens L, Vrints CJ, Khashaba A, Laine M, Van Belle E, Krackhardt F, Bojara W, Going O, Harle T, Indolfi C, Niccoli G, Ribichini F, Tanaka N, Yokoi H, Takashima H, Kikuta Y, Erglis A, Vinhas H, Canas Silva P, Baptista SB, Alghamdi A, Hellig F, Koo BK, Nam CW, Shin ES, Doh JH, Brugaletta S, Alegria-Barrero E, Meuwissen M, Piek JJ, van Royen N, Sezer M, Di Mario C, Gerber RT, Malik IS, Sharp ASP, Talwar S, Tang K, Samady H, Altman J, Seto AH, Singh J, Jeremias A, Matsuo H, Kharbanda RK, Patel MR, Serruys P, Escaned J. Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI. N Engl J Med. 2017 May 11;376(19):1824-1834. doi: 10.1056/NEJMoa1700445. Epub 2017 Mar 18.

    PubMed 28317458

  • Gotberg M, Christiansen EH, Gudmundsdottir IJ, Sandhall L, Danielewicz M, Jakobsen L, Olsson SE, Ohagen P, Olsson H, Omerovic E, Calais F, Lindroos P, Maeng M, Todt T, Venetsanos D, James SK, Karegren A, Nilsson M, Carlsson J, Hauer D, Jensen J, Karlsson AC, Panayi G, Erlinge D, Frobert O; iFR-SWEDEHEART Investigators. Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI. N Engl J Med. 2017 May 11;376(19):1813-1823. doi: 10.1056/NEJMoa1616540. Epub 2017 Mar 18.

    PubMed 28317438

  • 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

  • Hamilos M, Muller O, Cuisset T, Ntalianis A, Chlouverakis G, Sarno G, Nelis O, Bartunek J, Vanderheyden M, Wyffels E, Barbato E, Heyndrickx GR, Wijns W, De Bruyne B. Long-term clinical outcome after fractional flow reserve-guided treatment in patients with angiographically equivocal left main coronary artery stenosis. Circulation. 2009 Oct 13;120(15):1505-12. doi: 10.1161/CIRCULATIONAHA.109.850073. Epub 2009 Sep 28.

    PubMed 19786633

  • de la Torre Hernandez JM, Baz Alonso JA, Gomez Hospital JA, Alfonso Manterola F, Garcia Camarero T, Gimeno de Carlos F, Roura Ferrer G, Recalde AS, Martinez-Luengas IL, Gomez Lara J, Hernandez Hernandez F, Perez-Vizcayno MJ, Cequier Fillat A, Perez de Prado A, Gonzalez-Trevilla AA, Jimenez Navarro MF, Mauri Ferre J, Fernandez Diaz JA, Pinar Bermudez E, Zueco Gil J; IVUS-TRONCO-ICP Spanish study. Clinical impact of intravascular ultrasound guidance in drug-eluting stent implantation for unprotected left main coronary disease: pooled analysis at the patient-level of 4 registries. JACC Cardiovasc Interv. 2014 Mar;7(3):244-54. doi: 10.1016/j.jcin.2013.09.014.

    PubMed 24650399

  • Rodriguez-Leor O, de la Torre Hernandez JM, Garcia-Camarero T, Garcia Del Blanco B, Lopez-Palop R, Fernandez-Nofrerias E, Cuellas Ramon C, Jimenez-Kockar M, Jimenez-Mazuecos J, Fernandez Salinas F, Gomez-Lara J, Brugaletta S, Alfonso F, Palma R, Gomez-Menchero AE, Millan R, Tejada Ponce D, Linares Vicente JA, Ojeda S, Pinar E, Fernandez-Pelegrina E, Morales-Ponce FJ, Cid-Alvarez AB, Rama-Merchan JC, Molina Navarro E, Escaned J, Perez de Prado A. Instantaneous Wave-Free Ratio for the Assessment of Intermediate Left Main Coronary Artery Stenosis: Correlations With Fractional Flow Reserve/Intravascular Ultrasound and Prognostic Implications: The iLITRO-EPIC07 Study. Circ Cardiovasc Interv. 2022 Nov;15(11):861-871. doi: 10.1161/CIRCINTERVENTIONS.122.012328. Epub 2022 Sep 16.

    PubMed 36111801

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Left Main Coronary Artery Stenosis, run by Fundación EPIC at 38 sites in Spain.

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 7 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: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in Spain. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment correlation between FFR>=0.80 and iFR >=0.89 (time frame: 1 day). The study lists 4 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 NCT03767621, which also lists 11 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 5 Mar 2025.

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