Starring Optical Coherence Tomography During Percutaneous Coronary Intervention Guidance

NCT07182799 | Active Not Recruiting DMC

• 1 other identifier: 7262
• Study Type: observational
• Target: 3,200
• Locations: 1 country
• Sites: 1

Brief Summary

The starring optical coherence tomography during percutaneous coronary intervention guidance (OCT-AGEM) registry aims to evaluate the clinical impact of intra-procedural optical coherence tomography (OCT) in coronary revascularization, both in guiding revascularization decisions and optimizing interventional procedural outcomes, as well as assessing mid- and long-term clinical results.

Conditions

Acute Coronary Syndromes (ACS); Chronic Coronary Syndrome; MINOCA; INOCA (Ischemia With Non Obstructive Coronary Artery Disease); Percutaneous Coronary Intervention (PCI); Coronary Stent Implantation; Stent Restenosis; Stent Thrombosis; Clinical Outcome

Keywords

Percutaneous coronary intervention; Optical Coherence Tomography; Acute coronary syndrome; Chronic coronary syndrome; Clinical outcome; Coronary plaque; Coronary stent optimization

Outcome Measures

Primary Outcomes (2)

• Number of patients with cardiac death or target-vessel myocardial infarction or target lesion revascularization (non-interventional group)

  Composite outcome including cardiac death (i.e. any death due to heart disease, including heart failure, myocardial infarction, arrhythmia, and sudden unexpected death), target-vessel myocardial infarction (i.e. any spontaneous myocardial infarction attributed to the vessel studied with OCT), and target lesion revascularization (i.e. any target-lesion revascularization by means of percutaneous coronary intervention and coronary artery bypass grafting).

  1 year, 3 years, and 5 years

• Number of patients with cardiac death or target-vessel myocardial infarction or target lesion revascularization or stent restenosis/thrombosis (interventional group)

  Composite outcome including cardiac death (i.e. any death due to heart disease, including heart failure, myocardial infarction, arrhythmia, and sudden unexpected death), target-vessel myocardial infarction (i.e. any spontaneous myocardial infarction attributed to the vessel studied with OCT), target lesion revascularization (i.e. any target-lesion revascularization by means of percutaneous coronary intervention and coronary artery bypass grafting), and stent restenosis (i.e. angiographic in-stent stenosis/thrombosis \>50%).

  1 year, 3 years, and 5 years

Secondary Outcomes (6)

• Predictive value of single vulnerable plaque OCT-derived criteria (non-interventional and interventional group) in terms of incidence of the primary and secondary outcomes

  1 year, 3 years, and 5 years

• Predictive clinical value of single pre-specified plaque/stent OCT features in patients undergoing percutaneous coronary revascularization (interventional group) in terms of incidence of the primary and secondary outcomes

  1 year, 3 years, and 5 years

• Number of patients with cardiac death

  1 year, 3 years, and 5 years

• Number of patients with non-fatal spontaneous target-vessel myocardial infarction (excluding peri-procedural myocardial infarction)

  1 year, 3 years, and 5 years

• Number of patients with target lesion revascularization

  1 year, 3 years, and 5 years

Study Arms (2)

Non-interventional

Patients undergoing an OCT coronary assessment during a clinically indicated coronary angiogram, resulting in a non-obstructive coronary artery disease

Diagnostic Test: Plaque vulnerability assessment

Interventional

Patients undergoing an OCT coronary assessment during a clinically indicated coronary angiogram, guiding a percutaneous coronary intervention

Diagnostic Test: Stent implantation optimization

Interventions

Plaque vulnerability assessment DIAGNOSTIC_TEST

The purpose of the OCT-AGEM registry is to confirm the clinical utility of plaque OCT assessment over the standard coronary angiography evaluation. In particular, this ambispective cohort study aims to validate the predictive value of the OCT-based plaque vulnerability criteria: * Minimum lumen area \<3.5 mm2; * Fibrous cap minimum thickness \<65 µm; * Lipid arc extension \>180°; * Presence of macrophages; * Superficial and deep calcified nodules * Ulceration/Erosion/Dissection * Layered tissue * Optical flow ratio (OFR)

Also known as: Minimum lumen area, Fibrous cap minimum thickness, Lipid arc extension, Presence of macrophages, Superficial and deep calcified nodules, Ulceration/Erosion/Dissection, Layered tissue, Plaque burden (%), Optical flow ratio (OFR)

Non-interventional

Stent implantation optimization DIAGNOSTIC_TEST

The purpose of the OCT-AGEM registry is to confirm the clinical utility of OCT guidance during PCI over the standard coronary angiography evaluation. In particular, this ambispective cohort study aims to validate the predictive value of the OCT-derived plaque/stent parameters reported in expert consensus OCT documents, utilizing the cut-off points identified in the previous OCT registries

Also known as: Minimum lumen area, Fibrous cap minimum thickness, Lipid arc extension, Presence of macrophages, Superficial and deep calcified nodules, Ulceration/Erosion/Dissection, Layered tissue, Plaque burden (%), Stent edge dissection, Reference narrowing, Stent malapposition, Minimum stent area, Stent expansion (%), In-stent tissue protrusion, Stent deformation, Stent geometry, Neo-carina shaping, Optical flow ratio (OFR)

Interventional

Eligibility Criteria

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

Study Population

All subjects over 18 years who are undergoing an OCT coronary assessment during clinically indicated coronary angiogram regardless of the clinical syndrome (silent ischemia, effort angina or acute coronary syndrome).

You may qualify if:

• Age over 18 years;
• Patients with clinical indication to coronary angiography undergoing intra-procedural OCT regardless of the clinical syndrome;
• Patients with at least one end-procedural OCT assessment with a sufficient acquisition length to address the whole length of plaque or stented segments plus the proximal and distal reference segments;
• Patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the Ethical Committee of the respective clinical site.

You may not qualify if:

• Female with childbearing potential or lactating;
• Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl and/or glomerular filtration rate \<30 ml/min);
• Advanced heart failure (NYHA III-IV);
• Previous heart transplantation;
• Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year;
• Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study;
• Heavily calcified lesion or tortuous vessel which cannot be successfully imaged by OCT;
• Lesion located at the coronary ostium or in angulated (\>70°), sharp take-off vessel;

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Rome, 00168, Italy

Location

Related Publications (22)

• Prati F, Romagnoli E, Gatto L, La Manna A, Burzotta F, Limbruno U, Versaci F, Fabbiocchi F, Di Giorgio A, Marco V, Ramazzotti V, Di Vito L, Trani C, Porto I, Boi A, Tavazzi L, Mintz GS. Clinical Impact of Suboptimal Stenting and Residual Intrastent Plaque/Thrombus Protrusion in Patients With Acute Coronary Syndrome: The CLI-OPCI ACS Substudy (Centro per la Lotta Contro L'Infarto-Optimization of Percutaneous Coronary Intervention in Acute Coronary Syndrome). Circ Cardiovasc Interv. 2016 Dec;9(12):e003726. doi: 10.1161/CIRCINTERVENTIONS.115.003726.

  PMID: 27965297 BACKGROUND

• Romagnoli E, Gatto L, La Manna A, Burzotta F, Taglieri N, Saia F, Amico F, Marco V, Ramazzotti V, Di Giorgio A, Di Vito L, Boi A, Contarini M, Castriota F, Mintz GS, Prati F. Role of residual acute stent malapposition in percutaneous coronary interventions. Catheter Cardiovasc Interv. 2017 Oct 1;90(4):566-575. doi: 10.1002/ccd.26974. Epub 2017 Mar 15.

  PMID: 28295990 BACKGROUND

• Prati F, Romagnoli E, La Manna A, Burzotta F, Gatto L, Marco V, Fineschi M, Fabbiocchi F, Versaci F, Trani C, Tamburino C, Alfonso F, Mintz GS. Long-term consequences of optical coherence tomography findings during percutaneous coronary intervention: the Centro Per La Lotta Contro L'infarto - Optimization Of Percutaneous Coronary Intervention (CLI-OPCI) LATE study. EuroIntervention. 2018 Jul 20;14(4):e443-e451. doi: 10.4244/EIJ-D-17-01111.

  PMID: 29633940 BACKGROUND

• Gatto L, Alfonso F, Paoletti G, Burzotta F, La Manna A, Budassi S, Biccire FG, Fineschi M, Marco V, Fabbiocchi F, Vergallo R, Boi A, Ruscica G, Versaci F, Taglieri N, Calligaris G, Albertucci M, Romagnoli E, Ramazzotti V, Tamburino C, Crea F, Ozaki Y, Arbustini E, Prati F. Relationship betweeen the amount and location of macrophages and clinical outcome: subanalysis of the CLIMA-study. Int J Cardiol. 2022 Jan 1;346:8-12. doi: 10.1016/j.ijcard.2021.11.042. Epub 2021 Nov 17.

  PMID: 34798205 BACKGROUND

• Prati F, Romagnoli E, Biccire FG, Burzotta F, La Manna A, Budassi S, Ramazzotti V, Albertucci M, Fabbiocchi F, Sticchi A, Trani C, Calligaris G, Fineschi M, Versaci F, Tamburino C, Ozaki Y, Alfonso F, Mintz GS. Clinical outcomes of suboptimal stent deployment as assessed by optical coherence tomography: long-term results of the CLI-OPCI registry. EuroIntervention. 2022 Jun 3;18(2):e150-e157. doi: 10.4244/EIJ-D-21-00627.

  PMID: 34825652 BACKGROUND

• Romagnoli E, Ramazzotti V, Burzotta F, Gatto L, Marco V, Paoletti G, Biondi-Zoccai G, Alfonso F, Crea F, Trani C, Prati F; CLI-OPCI Project Investigators*. Definition of Optimal Optical Coherence Tomography-Based Stent Expansion Criteria: In-Stent Minimum Lumen Area Versus Residual Stent Underexpansion. Circ Cardiovasc Interv. 2022 Sep;15(9):e011496. doi: 10.1161/CIRCINTERVENTIONS.121.011496. Epub 2022 Sep 20.

  PMID: 36126136 BACKGROUND

• Romagnoli E, Burzotta F, Vergallo R, Gatto L, Biondi-Zoccai G, Ramazzotti V, Biccire F, Budassi S, Trani C, Ali Z, Stone GW, Prati F. Clinical impact of OCT-derived suboptimal stent implantation parameters and definitions. Eur Heart J Cardiovasc Imaging. 2023 Dec 21;25(1):48-57. doi: 10.1093/ehjci/jead172.

  PMID: 37463223 BACKGROUND

• Biccire FG, Fabbiocchi F, Gatto L, La Manna A, Ozaki Y, Romagnoli E, Marco V, Boi A, Fineschi M, Piedimonte G, Cerrato E, Musto C, Taglieri N, Di Giorgio A, Vizzari G, Ruscica G, Canova PA, Vergallo R, Burzotta F, Limbruno U, Albertucci M, Raber L, Crea F, Alfonso F, Arbustini E, Stone GW, Prati F. Long-Term Prognostic Impact of OCT-Derived High-Risk Plaque Features: Extended Follow-Up of the CLIMA Study. JACC Cardiovasc Interv. 2025 Jun 9;18(11):1361-1372. doi: 10.1016/j.jcin.2025.04.044.

  PMID: 40500004 BACKGROUND

• Tanigawa J, Barlis P, Di Mario C. Intravascular optical coherence tomography: optimisation of image acquisition and quantitative assessment of stent strut apposition. EuroIntervention. 2007 May;3(1):128-36.

  PMID: 19737696 BACKGROUND

• Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, Gold HK, Virmani R. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007 May 8;115(18):2435-41. doi: 10.1161/CIRCULATIONAHA.107.693739. Epub 2007 Apr 16.

  PMID: 17438147 BACKGROUND

• Niccoli G, Montone RA, Di Vito L, Gramegna M, Refaat H, Scalone G, Leone AM, Trani C, Burzotta F, Porto I, Aurigemma C, Prati F, Crea F. Plaque rupture and intact fibrous cap assessed by optical coherence tomography portend different outcomes in patients with acute coronary syndrome. Eur Heart J. 2015 Jun 7;36(22):1377-84. doi: 10.1093/eurheartj/ehv029. Epub 2015 Feb 18.

  PMID: 25713314 BACKGROUND

• Prati F, Uemura S, Souteyrand G, Virmani R, Motreff P, Di Vito L, Biondi-Zoccai G, Halperin J, Fuster V, Ozaki Y, Narula J. OCT-based diagnosis and management of STEMI associated with intact fibrous cap. JACC Cardiovasc Imaging. 2013 Mar;6(3):283-7. doi: 10.1016/j.jcmg.2012.12.007.

  PMID: 23473109 BACKGROUND

• Souteyrand G, Arbustini E, Motreff P, Gatto L, Di Vito L, Marco V, Amabile N, Chisari A, Kodama T, Romagnoli E, Tavazzi L, Crea F, Narula J, Prati F. Serial optical coherence tomography imaging of ACS-causing culprit plaques. EuroIntervention. 2015 Jul;11(3):319-24. doi: 10.4244/EIJV11I3A59.

  PMID: 26196754 BACKGROUND

• Tearney GJ, Regar E, Akasaka T, Adriaenssens T, Barlis P, Bezerra HG, Bouma B, Bruining N, Cho JM, Chowdhary S, Costa MA, de Silva R, Dijkstra J, Di Mario C, Dudek D, Falk E, Feldman MD, Fitzgerald P, Garcia-Garcia HM, Gonzalo N, Granada JF, Guagliumi G, Holm NR, Honda Y, Ikeno F, Kawasaki M, Kochman J, Koltowski L, Kubo T, Kume T, Kyono H, Lam CC, Lamouche G, Lee DP, Leon MB, Maehara A, Manfrini O, Mintz GS, Mizuno K, Morel MA, Nadkarni S, Okura H, Otake H, Pietrasik A, Prati F, Raber L, Radu MD, Rieber J, Riga M, Rollins A, Rosenberg M, Sirbu V, Serruys PW, Shimada K, Shinke T, Shite J, Siegel E, Sonoda S, Suter M, Takarada S, Tanaka A, Terashima M, Thim T, Uemura S, Ughi GJ, van Beusekom HM, van der Steen AF, van Es GA, van Soest G, Virmani R, Waxman S, Weissman NJ, Weisz G; International Working Group for Intravascular Optical Coherence Tomography (IWG-IVOCT). Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies: a report from the International Working Group for Intravascular Optical Coherence Tomography Standardization and Validation. J Am Coll Cardiol. 2012 Mar 20;59(12):1058-72. doi: 10.1016/j.jacc.2011.09.079. Erratum In: J Am Coll Cardiol. 2012 May 1;59(18):1662. Dudeck, Darius [corrected to Dudek, Darius]; Falk, Erlin [corrected to Falk, Erling]; Garcia, Hector [corrected to Garcia-Garcia, Hector M]; Sonada, Shinjo [corrected to Sonoda, Shinjo]; Troels, Thim [corrected to Thim, Troels]; van Es, Gerrit-Ann [correct.

  PMID: 22421299 BACKGROUND

• Prati F, Guagliumi G, Mintz GS, Costa M, Regar E, Akasaka T, Barlis P, Tearney GJ, Jang IK, Arbustini E, Bezerra HG, Ozaki Y, Bruining N, Dudek D, Radu M, Erglis A, Motreff P, Alfonso F, Toutouzas K, Gonzalo N, Tamburino C, Adriaenssens T, Pinto F, Serruys PW, Di Mario C; Expert's OCT Review Document. Expert review document part 2: methodology, terminology and clinical applications of optical coherence tomography for the assessment of interventional procedures. Eur Heart J. 2012 Oct;33(20):2513-20. doi: 10.1093/eurheartj/ehs095. Epub 2012 May 31. No abstract available.

  PMID: 22653335 BACKGROUND

• 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.

  PMID: 31918942 BACKGROUND

• 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.

  PMID: 31504405 BACKGROUND

• Di Vito L, Cattabiani MA, Paoletti G, Yoon JH, Chisari A, Gramegna M, Versaci F, Castriota F, Prati F. Comparison between intermediate and severe coronary stenoses and clinical outcomes of an OCT-guided PCI strategy. J Cardiovasc Med (Hagerstown). 2016 May;17(5):361-7. doi: 10.2459/JCM.0000000000000280.

  PMID: 26258719 BACKGROUND

• Prati F, Romagnoli E, Burzotta F, Limbruno U, Gatto L, La Manna A, Versaci F, Marco V, Di Vito L, Imola F, Paoletti G, Trani C, Tamburino C, Tavazzi L, Mintz GS. Clinical Impact of OCT Findings During PCI: The CLI-OPCI II Study. JACC Cardiovasc Imaging. 2015 Nov;8(11):1297-305. doi: 10.1016/j.jcmg.2015.08.013.

  PMID: 26563859 BACKGROUND

• Prati F, Di Vito L, Biondi-Zoccai G, Occhipinti M, La Manna A, Tamburino C, Burzotta F, Trani C, Porto I, Ramazzotti V, Imola F, Manzoli A, Materia L, Cremonesi A, Albertucci M. Angiography alone versus angiography plus optical coherence tomography to guide decision-making during percutaneous coronary intervention: the Centro per la Lotta contro l'Infarto-Optimisation of Percutaneous Coronary Intervention (CLI-OPCI) study. EuroIntervention. 2012 Nov 22;8(7):823-9. doi: 10.4244/EIJV8I7A125.

  PMID: 23034247 BACKGROUND

• Witzenbichler B, Maehara A, Weisz G, Neumann FJ, Rinaldi MJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Brodie BR, Stuckey TD, Mazzaferri EL Jr, Xu K, Parise H, Mehran R, Mintz GS, Stone GW. Relationship between intravascular ultrasound guidance and clinical outcomes after drug-eluting stents: the assessment of dual antiplatelet therapy with drug-eluting stents (ADAPT-DES) study. Circulation. 2014 Jan 28;129(4):463-70. doi: 10.1161/CIRCULATIONAHA.113.003942. Epub 2013 Nov 26.

  PMID: 24281330 BACKGROUND

• Ahn JM, Kang SJ, Yoon SH, Park HW, Kang SM, Lee JY, Lee SW, Kim YH, Lee CW, Park SW, Mintz GS, Park SJ. Meta-analysis of outcomes after intravascular ultrasound-guided versus angiography-guided drug-eluting stent implantation in 26,503 patients enrolled in three randomized trials and 14 observational studies. Am J Cardiol. 2014 Apr 15;113(8):1338-47. doi: 10.1016/j.amjcard.2013.12.043. Epub 2014 Jan 31.

  PMID: 24685326 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome; MINOCA

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Enrico Romagnoli, MD, PhD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

• Francesco Burzotta, MD, PhD

  Catholic University of the Sacred Heart

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Physician, Principal investigator

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 19, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): September 1, 2036
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

IT (1)