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

Coronary Artery Disease Clinical Trial

— iLITRO  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03767621
• Other study ID #: iLITRO EPIC-07
• Status: Active, not recruiting
• Start date: February 19, 2019
• Est. completion date: November 30, 2025

Study information

• Verified date: February 2024
• Source: Fundación EPIC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: November 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Restenosis
• Coronary Stenosis
• Left Main Coronary Artery Disease
• Left Main Coronary Artery Stenosis
• Myocardial Ischemia
• Restenosis, Coronary

Intervention

Other:
• Indication of revascularization
Device: iFR/FFR

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Albacete	Albacete
Spain	Hospital Universitario de Badajoz	Badajoz
Spain	Hospital Universitari Germans Trias I Pujol de Badalona	Badalona
Spain	Hospital Clinic I Provincial de Barcelona	Barcelona
Spain	Hospital de La Santa Creu I Sant Pau	Barcelona
Spain	Hospital Del Mar	Barcelona
Spain	Hospital Universitari Bellvitge	Barcelona
Spain	Hospital Universitari Vall D'Hebron	Barcelona
Spain	Hospital Universitario Puerto Real	Cadiz
Spain	Hospital General Universitario de Santa Lucia de Cartagena	Cartagena	Murcia
Spain	Hospital General Universitario de Castellón	Castellón De La Plana	Valencia
Spain	Hospital General de Ciudad Real	Ciudad Real
Spain	Hospital Universitario Reina Sofia	Córdoba
Spain	Hospital Clinico Universitario Virgen de La Arrixaca	El Palmar	Murcia
Spain	Hospital Galdakao-Usansolo	Galdakao	Vizcaya
Spain	Hospital Universitario de Cabueñes	Gijón
Spain	Hospital Universitari Doctor Josep Trueta	Girona
Spain	Hospital Universitario Virgen de Las Nieves	Granada
Spain	Hospital General Juan Ramón Jiménez	Huelva
Spain	Hospital de León	León
Spain	Hospital Universitari Lucus Agusti	Lugo
Spain	Clinica Universitaria de Navarra	Madrid
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital de La Princesa	Madrid
Spain	Hospital Universitario de La Paz	Madrid
Spain	Hospital Universitario Virgen de La Victoria	Málaga
Spain	Hospital de Merida	Mérida
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Hospital Universitario de Donostia	San Sebastián
Spain	Hospital Universitario Marqués de Valdecilla	Santander
Spain	Hospital Clinico Universitario de Santiago de Compostela	Santiago De Compostela
Spain	Hospital Universitari Joan Xxiii de Tarragona	Tarragona
Spain	Hospital Universitari Mutua de Terrassa	Terrassa	Barcelona
Spain	Hospital Universitario Virgen de La Salud	Toledo
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Universitari I Politecnic La Fe	Valencia
Spain	Hospital Universitario Alvaro Cunqueiro	Vigo
Spain	Hospital Clinico Universitario Lozano Blesa	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Fundación EPIC

Country where clinical trial is conducted

Spain, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day
Primary	Major Adverse Cardiac Events	Composite of death, myocardial infarction, unplanned revascularisation	30 days
Primary	Major Adverse Cardiac Events	Composite of death, myocardial infarction, unplanned revascularisation	1 year
Primary	Major Adverse Cardiac Events	Composite of death, myocardial infarction, unplanned revascularisation	5 years
Secondary	Assessment correlation between iFR and IVUS	Assessment correlation between iFR and IVUS derived minimal luminal area	5 years
Secondary	Death (all cause)	Death (all cause)	30 days, 1 and 5 years
Secondary	Death (cardiovascular)	Death (cardiovascular)	30 days, 1 and 5 years
Secondary	Non-fatal Myocardial Infarction	Non-fatal Myocardial Infarction	30 days, 1 and 5 years
Secondary	Non-fatal Myocardial Infarction related to the LMCA lesion	Non-fatal Myocardial Infarction related to the LMCA lesion	30 days, 1 and 5 years
Secondary	Revascularization	Revascularization	30 days, 1 and 5 years
Secondary	Revascularization of the target lesion	Revascularization of the target lesion	30 days, 1 and 5 years
Secondary	Myocardial Infarction related to target lesion revascularization	Myocardial Infarction related to target lesion revascularization	30 days, 1 and 5 years
Secondary	Stent Thrombosis in the target lesion revascularization	Stent Thrombosis in the target lesion revascularization	30 days, 1 and 5 years
Secondary	Restenosis of the stent in target lesion	Restenosis of the stent in target lesion	30 days, 1 and 5 years
Secondary	New revascularization of the target lesion	New revascularization of the target lesion	30 days, 1 and 5 years