Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS
NCT ID: NCT05027984
Last Updated: 2025-07-28
Study Results
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Basic Information
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RECRUITING
NA
1420 participants
INTERVENTIONAL
2021-06-30
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intermediate lesion OCT-based management
At OCT analysis, lesion features prompting intervention instead of conservative approach will be the following:
1. FCT \<75 µm, plus at least 2 of 3 other OCT criteria of plaque vulnerability (i.e., MLA \<3.5 mm2, lipid arc with circumferential extension \>180°, and the presence of macrophages).
2. The presence of intracoronary thrombus at a non-culprit site, irrespective of the presence of other vulnerability criteria, may prompt treatment with DES, at the operator's discretion.
All lesions fulfilling these interventional criteria will be treated with an OCT guided DES implantation in order to achieve an optimal stent implantation.
In presence of a MLA \<2.0 mm2, best cut-off showing correlation with fractional-flow reserve positive functional (FFR) assessment, clinical decision whether to treat the lesion will be based on FFR assessment irrespective of the presence of other criteria of vulnerability. Alternatively authors will have the option to treat the lesion with a DES.
Optical coherence tomography
OCT images will be acquired by means of the FD C7 XR system or the OPTIS system (both St. Jude Medical, St. Paul, MN, USA) with a non-occlusive technique.(33) The acquired OCT coronary images will be analyzed on-line using a proprietary OCT console (St Jude Medical, Inc., USA). Definitions and cut-offs for OCT vulnerability parameters derived from available consensus documents and from main IVUS/OCT studies.
Intermediate lesion physiology-based management
The iFR/FFR/RFR measurements will be obtained using a coronary-pressure guidewire. For FFR, hyperemia will be induced with the administration of intravenous adenosine, in accordance with the clinical practice at each participating center. Lesion features prompting intervention instead of conservative medical approach will be the following: iFR ≤0.89, or FFR ≤0.80.(32) All lesions fulfilling these interventional criteria will be treated with an FFR guided DES implantation. PCI will be performed with the aim of achieving a post-stenting FFR ≥0.90 (i.e. optimal FFR result). If post-stenting FFR was \<0.90 a further post-dilation of the stent could be performed and if FFR remained at \<0.90, a pullback of the wire to identify another possible pressure drop and/or a subsequent stent implantation at least 5 mm from the stent will be performed according to physician's preference.
iFR/FFR/RFR
The iFR and FFR measurements will be obtained using a coronary-pressure guidewire (Pressure Wire / Certus or Aeris for FFR assessment and PressureWire™ X Guidewire/QUANTIEM™ for the RFR assessment by Abbott Vascular, Abbott Park, Illinois, U.S.A; Comet by Boston Scientific, Marlborough, MA, USA), OptoWire by Opsens, Quebec, Canada, or Verrata by Philips, San Diego, CA, USA.).
Interventions
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Optical coherence tomography
OCT images will be acquired by means of the FD C7 XR system or the OPTIS system (both St. Jude Medical, St. Paul, MN, USA) with a non-occlusive technique.(33) The acquired OCT coronary images will be analyzed on-line using a proprietary OCT console (St Jude Medical, Inc., USA). Definitions and cut-offs for OCT vulnerability parameters derived from available consensus documents and from main IVUS/OCT studies.
iFR/FFR/RFR
The iFR and FFR measurements will be obtained using a coronary-pressure guidewire (Pressure Wire / Certus or Aeris for FFR assessment and PressureWire™ X Guidewire/QUANTIEM™ for the RFR assessment by Abbott Vascular, Abbott Park, Illinois, U.S.A; Comet by Boston Scientific, Marlborough, MA, USA), OptoWire by Opsens, Quebec, Canada, or Verrata by Philips, San Diego, CA, USA.).
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of acute coronary syndrome.
* Single or multiple intermediate lesions in intervention-naïve major coronary segments (diameter ≥2.5 mm) determining a 40-70% diameter stenosis by visual assessment with no other significant stenosis (\>70%) in the same vessel.
* Patient informed of the nature of the study, agreeing to it, and providing written informed consent as approved by the Ethics Committee of the respective clinical study site.
* Life expectancy \>3 years.
Exclusion Criteria
* Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl).
* Advanced heart failure (NYHA III-IV)
* Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time.
* Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial.
* Coronary anatomy preventing complete imaging of the segment of interest (including at least 5 mm at both stenosis edges).
* Lesions located in the left main coronary artery
* Diffusely diseased coronary artery segment or presence of ≥1 significant untreated non-culprit lesions (preventing correct adverse event attribution) in the coronary arteries.
* Prior myocardial infarction or coronary artery bypass graft \[CABG\] or PCI revascularization in the target coronary vessel.
* Coronary anatomy unsuitable for PCI.
* Comorbidities that might interfere with completion of the study procedures.
* Planned major surgery necessitating interruption of dual antiplatelet.
* Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study.
18 Years
ALL
No
Sponsors
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Abbott Vascular (Santa Clara, USA)
UNKNOWN
Centro per la Lotta Contro l'Infarto - Fondazione Onlus
OTHER
Responsible Party
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Francesco Prati
President of Centro per la Lotta Contro l'Infarto - Fondazione Onlus
Principal Investigators
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Francesco Prati, MD
Role: PRINCIPAL_INVESTIGATOR
Centro per la Lotta con l'Infarto - CLI Foundation
Locations
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University Hospital of Patras
Pátrai, AX, Greece
Ospedale C. e G. Mazzoni
Ascoli Piceno, AP, Italy
Ente ecclesiastico Ospedale Regionale Generale "F. Miulli"
Acquaviva delle Fonti, BA, Italy
Policlinico University Hospital
Bari, BA, Italy
Di Venere Hospital
Bari, BA, Italy
ASST Papa Giovanni XXIII
Bergamo, BG, Italy
Azienda Ospedaliera San Pio
Benevento, BN, Italy
Azienda Ospedaliero_Universitaria IRCCS Policlinico di St.Orsola
Bologna, BO, Italy
ARNAS Brotzu
Cagliari, CA, Italy
P.O. San Giuseppe Moscati
Aversa, CE, Italy
Azienda Ospedaliera "Policlinico "G. Rodolico- San Marco"
Catania, CT, Italy
Azienda Ospedaliera Per L'emergenza Cannizzaro
Catania, CT, Italy
IRCCS Casa sollievo della sofferenza
San Giovanni Rotondo, FG, Italy
IRCCS Ospedale Policlinico San Martino
Genova, GE, Italy
Misericordia Hospital
Grosseto, GR, Italy
Ospedale Vito Fazzi
Lecce, LE, Italy
Ospedale Santa Maria Goretti, Latina
Latina, LT, Italy
Azienda Ospedaliero Universitaria Policlinico "G. Martino", Messina
Messina, ME, Italy
Centro Cardiologico Monzino IRCCS
Milan, MI, Italy
IRCCS Galeazzi- Sant'Ambrogio
Milan, MI, Italy
San Camillo Hospital
Roma, RM, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, RM, Italy
UOSA Cardiologia Interventistica
Siena, SI, Italy
P.O. Umberto I
Syracuse, SR, Italy
Struttura Complessa di Cardiologia Clinica e Interventistica
Sassari, SS, Italy
Rivoli Hospital
Rivoli, TO, Italy
Ospedale Conegliano
Conegliano, TV, Italy
Azienda Sanitaria Universitaria Friuli Centrale - Udine University Hospital
Udine, UD, Italy
Federico II di Napoli
Napoli, , Italy
San Giovanni Hospital
Rome, , Italy
Hospital Virgen de la Victoria
Málaga, MA, Spain
Hospital universitario La Princesa, Madrid
Madrid, M, Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Inselspital, Bern University Hospital
Bern, Canton of Bern, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Michail Papafaklis, MD PHD
Role: primary
Luca Di Vito, MD
Role: primary
Elia Iorio, MD
Role: primary
Nicola Signore, MD
Role: primary
Francesco Cassano, MD
Role: primary
Paolo Canova, MD
Role: primary
Marino Scherillo, MD
Role: primary
Nevio Taglieri, MD
Role: primary
Alberto BOI, MD
Role: primary
Gianluca Caiazzo, MD
Role: primary
Piera Capranzano, MD
Role: primary
Francesco Amico, MD
Role: primary
Carlo Vigna, MD
Role: primary
Italo Porto, MD
Role: primary
Andrea Picchi, MD
Role: primary
Dionigi Fischetti, MD
Role: primary
Francesco Versaci, MD
Role: primary
Giampiero Vizzari, MD
Role: primary
Giuseppe Calligaris, MD
Role: primary
Franco Fabbiocchi, MD
Role: primary
Carmine Musto, MD PHD
Role: primary
Enrico Romagnoli, MD
Role: primary
Massimo Fineschi, MD
Role: primary
Marco Contarini, MD
Role: primary
Gavino Casu, MD
Role: primary
Giulio Piedimonte, MD
Role: primary
Gerlando Preti, MD
Role: primary
Enrico Favaretto, MD
Role: primary
Giovanni Esposito, MD
Role: primary
Francesco Prati, MD
Role: primary
Alonso Briales Juan H, MD
Role: primary
Alfonso Fernando, MD PHD
Role: primary
Paula Antuna, MD
Role: primary
Lorenz Räber, MD, PHD
Role: primary
References
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Tonino PA, Fearon WF, De Bruyne B, Oldroyd KG, Leesar MA, Ver Lee PN, Maccarthy PA, Van't Veer M, Pijls NH. Angiographic versus functional severity of coronary artery stenoses in the FAME study fractional flow reserve versus angiography in multivessel evaluation. J Am Coll Cardiol. 2010 Jun 22;55(25):2816-21. doi: 10.1016/j.jacc.2009.11.096.
Toth G, Hamilos M, Pyxaras S, Mangiacapra F, Nelis O, De Vroey F, Di Serafino L, Muller O, Van Mieghem C, Wyffels E, Heyndrickx GR, Bartunek J, Vanderheyden M, Barbato E, Wijns W, De Bruyne B. Evolving concepts of angiogram: fractional flow reserve discordances in 4000 coronary stenoses. Eur Heart J. 2014 Oct 21;35(40):2831-8. doi: 10.1093/eurheartj/ehu094. Epub 2014 Mar 18.
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.
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.
Burzotta F, Leone AM, Aurigemma C, Zambrano A, Zimbardo G, Arioti M, Vergallo R, De Maria GL, Cerracchio E, Romagnoli E, Trani C, Crea F. Fractional Flow Reserve or Optical Coherence Tomography to Guide Management of Angiographically Intermediate Coronary Stenosis: A Single-Center Trial. JACC Cardiovasc Interv. 2020 Jan 13;13(1):49-58. doi: 10.1016/j.jcin.2019.09.034.
Waksman R, Legutko J, Singh J, Orlando Q, Marso S, Schloss T, Tugaoen J, DeVries J, Palmer N, Haude M, Swymelar S, Torguson R. FIRST: Fractional Flow Reserve and Intravascular Ultrasound Relationship Study. J Am Coll Cardiol. 2013 Mar 5;61(9):917-23. doi: 10.1016/j.jacc.2012.12.012. Epub 2013 Jan 23.
Cho YK, Nam CW, Han JK, Koo BK, Doh JH, Ben-Dor I, Waksman R, Pichard A, Murata N, Tanaka N, Lee CH, Gonzalo N, Escaned J, Costa MA, Kubo T, Akasaka T, Hu X, Wang JA, Yang HM, Yoon MH, Tahk SJ, Yoon HJ, Chung IS, Hur SH, Kim KB. Usefulness of combined intravascular ultrasound parameters to predict functional significance of coronary artery stenosis and determinants of mismatch. EuroIntervention. 2015 Jun;11(2):163-70. doi: 10.4244/EIJV11I2A30.
Usui E, Yonetsu T, Kanaji Y, Hoshino M, Yamaguchi M, Hada M, Hamaya R, Kanno Y, Murai T, Lee T, Kakuta T. Efficacy of Optical Coherence Tomography-derived Morphometric Assessment in Predicting the Physiological Significance of Coronary Stenosis: Head-to-Head Comparison with Intravascular Ultrasound. EuroIntervention. 2018 Apr 6;13(18):e2210-e2218. doi: 10.4244/EIJ-D-17-00613.
D'Ascenzo F, Barbero U, Cerrato E, Lipinski MJ, Omede P, Montefusco A, Taha S, Naganuma T, Reith S, Voros S, Latib A, Gonzalo N, Quadri G, Colombo A, Biondi-Zoccai G, Escaned J, Moretti C, Gaita F. Accuracy of intravascular ultrasound and optical coherence tomography in identifying functionally significant coronary stenosis according to vessel diameter: A meta-analysis of 2,581 patients and 2,807 lesions. Am Heart J. 2015 May;169(5):663-73. doi: 10.1016/j.ahj.2015.01.013. Epub 2015 Feb 21.
Prati F, Romagnoli E, Gatto L, La Manna A, Burzotta F, Ozaki Y, Marco V, Boi A, Fineschi M, Fabbiocchi F, Taglieri N, Niccoli G, Trani C, Versaci F, Calligaris G, Ruscica G, Di Giorgio A, Vergallo R, Albertucci M, Biondi-Zoccai G, Tamburino C, Crea F, Alfonso F, Arbustini E. Relationship between coronary plaque morphology of the left anterior descending artery and 12 months clinical outcome: the CLIMA study. Eur Heart J. 2020 Jan 14;41(3):383-391. doi: 10.1093/eurheartj/ehz520.
Stone GW, Maehara A, Lansky AJ, de Bruyne B, Cristea E, Mintz GS, Mehran R, McPherson J, Farhat N, Marso SP, Parise H, Templin B, White R, Zhang Z, Serruys PW; PROSPECT Investigators. A prospective natural-history study of coronary atherosclerosis. N Engl J Med. 2011 Jan 20;364(3):226-35. doi: 10.1056/NEJMoa1002358.
Di Vito L, Agozzino M, Marco V, Ricciardi A, Concardi M, Romagnoli E, Gatto L, Calogero G, Tavazzi L, Arbustini E, Prati F. Identification and quantification of macrophage presence in coronary atherosclerotic plaques by optical coherence tomography. Eur Heart J Cardiovasc Imaging. 2015 Jul;16(7):807-13. doi: 10.1093/ehjci/jeu307. Epub 2015 Jan 14.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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CLI-01-2020
Identifier Type: -
Identifier Source: org_study_id
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