[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100441409":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":44,"responsibleParty":476,"collaborators":479,"id":483,"slug":484,"hasResults":485,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":485,"sex":491,"minAge":492,"maxAge":26,"enrollmentInfo":493,"targetDuration":26,"studyType":496,"phases":497,"briefSummary":499,"conditions":500,"keywords":504,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":516},{"fullName":5,"class":6},"Centro per la Lotta Contro l'Infarto - Fondazione Onlus","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intermediate lesion OCT-based management","EXPERIMENTAL","At OCT analysis, lesion features prompting intervention instead of conservative approach will be the following:\n\n1. FCT \\\u003C75 µm, plus at least 2 of 3 other OCT criteria of plaque vulnerability (i.e., MLA \\\u003C3.5 mm2, lipid arc with circumferential extension \\>180°, and the presence of macrophages).\n2. 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.\n\nAll lesions fulfilling these interventional criteria will be treated with an OCT guided DES implantation in order to achieve an optimal stent implantation.\n\nIn presence of a MLA \\\u003C2.0 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.",[13],"Device: Optical coherence tomography",{"label":15,"type":16,"description":17,"interventionNames":18},"Intermediate lesion physiology-based management","ACTIVE_COMPARATOR","The iFR\u002FFFR\u002FRFR 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 \\\u003C0.90 a further post-dilation of the stent could be performed and if FFR remained at \\\u003C0.90, a pullback of the wire to identify another possible pressure drop and\u002For a subsequent stent implantation at least 5 mm from the stent will be performed according to physician's preference.",[19],"Device: iFR\u002FFFR\u002FRFR",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","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\u002FOCT studies.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"iFR\u002FFFR\u002FRFR","The iFR and FFR measurements will be obtained using a coronary-pressure guidewire (Pressure Wire \u002F Certus or Aeris for FFR assessment and PressureWire™ X Guidewire\u002FQUANTIEM™ 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.).",[15],[32],{"name":33,"affiliation":34,"role":35},"Francesco Prati, MD","Centro per la Lotta con l'Infarto - CLI Foundation","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+39 0677055330","fprati61@gmail.com",{"name":42,"role":38,"phone":26,"phoneExt":26,"email":43},"Flavio Giuseppe Biccirè, MD, PhD","flaviobiccire@gmail.com",[45,62,77,90,102,111,124,137,150,163,176,190,199,212,225,237,250,263,276,289,298,311,320,333,346,359,372,385,398,410,421,436,449,461],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"University Hospital of Patras","RECRUITING","Pátrai","AX","26504","Greece","GR",{"type":54,"coordinates":55},"Point",[56,57],21.73508,38.2462,{"lat":57,"lon":56},[60],{"name":61,"role":38,"phone":26,"phoneExt":26,"email":26},"Michail Papafaklis, MD PHD",{"facility":63,"status":47,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Ospedale C. e G. Mazzoni","Ascoli Piceno","AP","63100","Italy","IT",{"type":54,"coordinates":70},[71,72],13.57395,42.85351,{"lat":72,"lon":71},[75],{"name":76,"role":38,"phone":26,"phoneExt":26,"email":26},"Luca Di Vito, MD",{"facility":78,"status":47,"city":79,"state":80,"zip":81,"country":67,"countryCode":68,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Ente ecclesiastico Ospedale Regionale Generale \"F. Miulli\"","Acquaviva delle Fonti","BA","70021",{"type":54,"coordinates":83},[84,85],16.8433,40.89704,{"lat":85,"lon":84},[88],{"name":89,"role":38,"phone":26,"phoneExt":26,"email":26},"Elia Iorio, MD",{"facility":91,"status":47,"city":92,"state":80,"zip":93,"country":67,"countryCode":68,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Policlinico University Hospital","Bari","70120",{"type":54,"coordinates":95},[96,97],16.86982,41.12066,{"lat":97,"lon":96},[100],{"name":101,"role":38,"phone":26,"phoneExt":26,"email":26},"Nicola Signore, MD",{"facility":103,"status":47,"city":92,"state":80,"zip":104,"country":67,"countryCode":68,"cosmosGeoPoint":105,"geoPoint":107,"contacts":108},"Di Venere Hospital","70131",{"type":54,"coordinates":106},[96,97],{"lat":97,"lon":96},[109],{"name":110,"role":38,"phone":26,"phoneExt":26,"email":26},"Francesco Cassano, MD",{"facility":112,"status":47,"city":113,"state":114,"zip":115,"country":67,"countryCode":68,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"ASST Papa Giovanni XXIII","Bergamo","BG","24127",{"type":54,"coordinates":117},[118,119],9.66721,45.69601,{"lat":119,"lon":118},[122],{"name":123,"role":38,"phone":26,"phoneExt":26,"email":26},"Paolo Canova, MD",{"facility":125,"status":47,"city":126,"state":127,"zip":128,"country":67,"countryCode":68,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Azienda Ospedaliera San Pio","Benevento","BN","82100",{"type":54,"coordinates":130},[131,132],14.77816,41.1307,{"lat":132,"lon":131},[135],{"name":136,"role":38,"phone":26,"phoneExt":26,"email":26},"Marino Scherillo, MD",{"facility":138,"status":47,"city":139,"state":140,"zip":141,"country":67,"countryCode":68,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Azienda Ospedaliero_Universitaria IRCCS Policlinico di St.Orsola","Bologna","BO","40138",{"type":54,"coordinates":143},[144,145],11.33875,44.49381,{"lat":145,"lon":144},[148],{"name":149,"role":38,"phone":26,"phoneExt":26,"email":26},"Nevio Taglieri, MD",{"facility":151,"status":47,"city":152,"state":153,"zip":154,"country":67,"countryCode":68,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"ARNAS Brotzu","Cagliari","CA","09047",{"type":54,"coordinates":156},[157,158],9.11917,39.23054,{"lat":158,"lon":157},[161],{"name":162,"role":38,"phone":26,"phoneExt":26,"email":26},"Alberto BOI, MD",{"facility":164,"status":47,"city":165,"state":166,"zip":167,"country":67,"countryCode":68,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"P.O. San Giuseppe Moscati","Aversa","CE","81031",{"type":54,"coordinates":169},[170,171],14.20745,40.97259,{"lat":171,"lon":170},[174],{"name":175,"role":38,"phone":26,"phoneExt":26,"email":26},"Gianluca Caiazzo, MD",{"facility":177,"status":178,"city":179,"state":180,"zip":181,"country":67,"countryCode":68,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Azienda Ospedaliera \"Policlinico \"G. Rodolico- San Marco\"","NOT_YET_RECRUITING","Catania","CT","95123",{"type":54,"coordinates":183},[184,185],15.07041,37.49223,{"lat":185,"lon":184},[188],{"name":189,"role":38,"phone":26,"phoneExt":26,"email":26},"Piera Capranzano, MD",{"facility":191,"status":47,"city":179,"state":180,"zip":192,"country":67,"countryCode":68,"cosmosGeoPoint":193,"geoPoint":195,"contacts":196},"Azienda Ospedaliera Per L'emergenza Cannizzaro","95126",{"type":54,"coordinates":194},[184,185],{"lat":185,"lon":184},[197],{"name":198,"role":38,"phone":26,"phoneExt":26,"email":26},"Francesco Amico, MD",{"facility":200,"status":47,"city":201,"state":202,"zip":203,"country":67,"countryCode":68,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"IRCCS Casa sollievo della sofferenza","San Giovanni Rotondo","FG","71013",{"type":54,"coordinates":205},[206,207],15.7277,41.70643,{"lat":207,"lon":206},[210],{"name":211,"role":38,"phone":26,"phoneExt":26,"email":26},"Carlo Vigna, MD",{"facility":213,"status":47,"city":214,"state":215,"zip":216,"country":67,"countryCode":68,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"IRCCS Ospedale Policlinico San Martino","Genova","GE","16132",{"type":54,"coordinates":218},[219,220],11.87211,45.21604,{"lat":220,"lon":219},[223],{"name":224,"role":38,"phone":26,"phoneExt":26,"email":26},"Italo Porto, MD",{"facility":226,"status":47,"city":227,"state":52,"zip":228,"country":67,"countryCode":68,"cosmosGeoPoint":229,"geoPoint":233,"contacts":234},"Misericordia Hospital","Grosseto","58100",{"type":54,"coordinates":230},[231,232],11.10941,42.76296,{"lat":232,"lon":231},[235],{"name":236,"role":38,"phone":26,"phoneExt":26,"email":26},"Andrea Picchi, MD",{"facility":238,"status":47,"city":239,"state":240,"zip":241,"country":67,"countryCode":68,"cosmosGeoPoint":242,"geoPoint":246,"contacts":247},"Ospedale Vito Fazzi","Lecce","LE","73100",{"type":54,"coordinates":243},[244,245],18.17244,40.35481,{"lat":245,"lon":244},[248],{"name":249,"role":38,"phone":26,"phoneExt":26,"email":26},"Dionigi Fischetti, MD",{"facility":251,"status":47,"city":252,"state":253,"zip":254,"country":67,"countryCode":68,"cosmosGeoPoint":255,"geoPoint":259,"contacts":260},"Ospedale Santa Maria Goretti, Latina","Latina","LT","04100",{"type":54,"coordinates":256},[257,258],12.9043,41.46614,{"lat":258,"lon":257},[261],{"name":262,"role":38,"phone":26,"phoneExt":26,"email":26},"Francesco Versaci, MD",{"facility":264,"status":47,"city":265,"state":266,"zip":267,"country":67,"countryCode":68,"cosmosGeoPoint":268,"geoPoint":272,"contacts":273},"Azienda Ospedaliero Universitaria Policlinico \"G. Martino\", Messina","Messina","ME","98124",{"type":54,"coordinates":269},[270,271],15.55256,38.19394,{"lat":271,"lon":270},[274],{"name":275,"role":38,"phone":26,"phoneExt":26,"email":26},"Giampiero Vizzari, MD",{"facility":277,"status":47,"city":278,"state":279,"zip":280,"country":67,"countryCode":68,"cosmosGeoPoint":281,"geoPoint":285,"contacts":286},"Centro Cardiologico Monzino IRCCS","Milan","MI","20138",{"type":54,"coordinates":282},[283,284],12.59836,42.78235,{"lat":284,"lon":283},[287],{"name":288,"role":38,"phone":26,"phoneExt":26,"email":26},"Giuseppe Calligaris, MD",{"facility":290,"status":47,"city":278,"state":279,"zip":291,"country":67,"countryCode":68,"cosmosGeoPoint":292,"geoPoint":294,"contacts":295},"IRCCS Galeazzi- Sant'Ambrogio","20157",{"type":54,"coordinates":293},[283,284],{"lat":284,"lon":283},[296],{"name":297,"role":38,"phone":26,"phoneExt":26,"email":26},"Franco Fabbiocchi, MD",{"facility":299,"status":47,"city":300,"state":301,"zip":302,"country":67,"countryCode":68,"cosmosGeoPoint":303,"geoPoint":307,"contacts":308},"San Camillo Hospital","Roma","RM","00152",{"type":54,"coordinates":304},[305,306],11.10642,44.99364,{"lat":306,"lon":305},[309],{"name":310,"role":38,"phone":26,"phoneExt":26,"email":26},"Carmine Musto, MD PHD",{"facility":312,"status":47,"city":300,"state":301,"zip":313,"country":67,"countryCode":68,"cosmosGeoPoint":314,"geoPoint":316,"contacts":317},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","00168",{"type":54,"coordinates":315},[305,306],{"lat":306,"lon":305},[318],{"name":319,"role":38,"phone":26,"phoneExt":26,"email":26},"Enrico Romagnoli, MD",{"facility":321,"status":47,"city":322,"state":323,"zip":324,"country":67,"countryCode":68,"cosmosGeoPoint":325,"geoPoint":329,"contacts":330},"UOSA Cardiologia Interventistica","Siena","SI","53100",{"type":54,"coordinates":326},[327,328],11.33064,43.31822,{"lat":328,"lon":327},[331],{"name":332,"role":38,"phone":26,"phoneExt":26,"email":26},"Massimo Fineschi, MD",{"facility":334,"status":47,"city":335,"state":336,"zip":337,"country":67,"countryCode":68,"cosmosGeoPoint":338,"geoPoint":342,"contacts":343},"P.O. Umberto I","Syracuse","SR","96100",{"type":54,"coordinates":339},[340,341],15.28664,37.07542,{"lat":341,"lon":340},[344],{"name":345,"role":38,"phone":26,"phoneExt":26,"email":26},"Marco Contarini, MD",{"facility":347,"status":178,"city":348,"state":349,"zip":350,"country":67,"countryCode":68,"cosmosGeoPoint":351,"geoPoint":355,"contacts":356},"Struttura Complessa di Cardiologia Clinica e Interventistica","Sassari","SS","07100",{"type":54,"coordinates":352},[353,354],8.55552,40.72586,{"lat":354,"lon":353},[357],{"name":358,"role":38,"phone":26,"phoneExt":26,"email":26},"Gavino Casu, MD",{"facility":360,"status":47,"city":361,"state":362,"zip":363,"country":67,"countryCode":68,"cosmosGeoPoint":364,"geoPoint":368,"contacts":369},"Rivoli Hospital","Rivoli","TO","10098",{"type":54,"coordinates":365},[366,367],7.51465,45.07073,{"lat":367,"lon":366},[370],{"name":371,"role":38,"phone":26,"phoneExt":26,"email":26},"Giulio Piedimonte, MD",{"facility":373,"status":47,"city":374,"state":375,"zip":376,"country":67,"countryCode":68,"cosmosGeoPoint":377,"geoPoint":381,"contacts":382},"Ospedale Conegliano","Conegliano","TV","31015",{"type":54,"coordinates":378},[379,380],12.30201,45.88805,{"lat":380,"lon":379},[383],{"name":384,"role":38,"phone":26,"phoneExt":26,"email":26},"Gerlando Preti, MD",{"facility":386,"status":47,"city":387,"state":388,"zip":389,"country":67,"countryCode":68,"cosmosGeoPoint":390,"geoPoint":394,"contacts":395},"Azienda Sanitaria Universitaria Friuli Centrale - Udine University Hospital","Udine","UD","33100",{"type":54,"coordinates":391},[392,393],13.23715,46.0693,{"lat":393,"lon":392},[396],{"name":397,"role":38,"phone":26,"phoneExt":26,"email":26},"Enrico Favaretto, MD",{"facility":399,"status":47,"city":400,"state":26,"zip":401,"country":67,"countryCode":68,"cosmosGeoPoint":402,"geoPoint":406,"contacts":407},"Federico II di Napoli","Naples","80138",{"type":54,"coordinates":403},[404,405],14.26811,40.85216,{"lat":405,"lon":404},[408],{"name":409,"role":38,"phone":26,"phoneExt":26,"email":26},"Giovanni Esposito, MD",{"facility":411,"status":47,"city":412,"state":26,"zip":413,"country":67,"countryCode":68,"cosmosGeoPoint":414,"geoPoint":418,"contacts":419},"San Giovanni Hospital","Rome","00184",{"type":54,"coordinates":415},[416,417],12.51133,41.89193,{"lat":417,"lon":416},[420],{"name":33,"role":38,"phone":26,"phoneExt":26,"email":26},{"facility":422,"status":47,"city":423,"state":424,"zip":425,"country":426,"countryCode":427,"cosmosGeoPoint":428,"geoPoint":432,"contacts":433},"Hospital Virgen de la Victoria","Málaga","MA","29010","Spain","ES",{"type":54,"coordinates":429},[430,431],-4.42034,36.72016,{"lat":431,"lon":430},[434],{"name":435,"role":38,"phone":26,"phoneExt":26,"email":26},"Alonso Briales Juan H, MD",{"facility":437,"status":47,"city":438,"state":439,"zip":440,"country":426,"countryCode":427,"cosmosGeoPoint":441,"geoPoint":445,"contacts":446},"Hospital universitario La Princesa, Madrid","Madrid","M","28006",{"type":54,"coordinates":442},[443,444],-3.70256,40.4165,{"lat":444,"lon":443},[447],{"name":448,"role":38,"phone":26,"phoneExt":26,"email":26},"Alfonso Fernando, MD PHD",{"facility":450,"status":47,"city":451,"state":26,"zip":452,"country":426,"countryCode":427,"cosmosGeoPoint":453,"geoPoint":457,"contacts":458},"Hospital Universitario Central de Asturias","Oviedo","33011",{"type":54,"coordinates":454},[455,456],-5.84476,43.36029,{"lat":456,"lon":455},[459],{"name":460,"role":38,"phone":26,"phoneExt":26,"email":26},"Paula Antuna, MD",{"facility":462,"status":47,"city":463,"state":464,"zip":465,"country":466,"countryCode":467,"cosmosGeoPoint":468,"geoPoint":472,"contacts":473},"Inselspital, Bern University Hospital","Bern","Canton of Bern","3010","Switzerland","CH",{"type":54,"coordinates":469},[470,471],7.44744,46.94809,{"lat":471,"lon":470},[474],{"name":475,"role":38,"phone":26,"phoneExt":26,"email":26},"Lorenz Räber, MD, PHD",{"type":35,"investigatorFullName":477,"investigatorTitle":478,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Francesco Prati","President of Centro per la Lotta Contro l'Infarto - Fondazione Onlus",[480],{"name":481,"class":482},"Abbott Vascular (Santa Clara, USA)","UNKNOWN","100441409","interventional-strategy-for-non-culprit-lesions-with-major-vulnerability-criteria-at-oct-in-patients-with-acs-100441409",false,"NCT05027984","Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS","An Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria Identified by Optical Coherence Tomography in Patients With Acute Coronary Syndrome (the INTER-CLIMA Trial)","INTERCLIMA","Inclusion Criteria:\n\n* Age of at least 18 years.\n* Diagnosis of acute coronary syndrome.\n* 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.\n* 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.\n* Life expectancy \\>3 years.\n\nExclusion criteria:\n\n* Female with childbearing potential or lactating.\n* Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg\u002Fdl).\n* Advanced heart failure (NYHA III-IV)\n* Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time.\n* Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial.\n* Coronary anatomy preventing complete imaging of the segment of interest (including at least 5 mm at both stenosis edges).\n* Lesions located in the left main coronary artery\n* Diffusely diseased coronary artery segment or presence of ≥1 significant untreated non-culprit lesions (preventing correct adverse event attribution) in the coronary arteries.\n* Prior myocardial infarction or coronary artery bypass graft \\[CABG\\] or PCI revascularization in the target coronary vessel.\n* Coronary anatomy unsuitable for PCI.\n* Comorbidities that might interfere with completion of the study procedures.\n* Planned major surgery necessitating interruption of dual antiplatelet.\n* Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study.","ALL","18 Years",{"count":494,"type":495},1420,"ESTIMATED","INTERVENTIONAL",[498],"NA","The INTERCLIMA (Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria Identified by Optical Coherence Tomography in Patients With Acute Coronary Syndrome) is a multi-center, prospective, randomized trial of optical coherence tomography (OCT)-based versus physiology-based (i.e. fractional flow reserve\\[FFR\\]\u002Finstantaneous Wave-Free Ratio\\[iFR\\]\u002Fresting full-cycle ratio\\[RFR\\]) treatment of intermediate (40-70% diameter stenosis), non-culprit coronary lesions in acute coronary syndrome (ACS) patients undergoing coronary angiography. About 1420 patients with ACS will be randomized into the study at approximately 40 sites worldwide.",[501,502,503],"Coronary Artery Disease","Coronary Disease","Ischemic Heart Disease",[505,23,506],"Coronary artery disease","Vulnerable plaque","2025-07-23",{"date":509,"type":510},"2025-07-28","ACTUAL",{"date":512,"type":510},"2021-06-30",{"date":514,"type":495},"2028-03-31",{"name":5,"class":6},34]