[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575963":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":216,"collaborators":24,"id":220,"slug":221,"hasResults":222,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":222,"sex":228,"minAge":229,"maxAge":230,"enrollmentInfo":231,"targetDuration":24,"studyType":234,"phases":235,"briefSummary":237,"conditions":238,"keywords":242,"overallStatus":34,"whyStopped":24,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":254},{"fullName":5,"class":6},"San Luigi Gonzaga Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"OCT arm (Group 1)","ACTIVE_COMPARATOR","PCI of ISR guided by OCT (group 1): in this case, the operator has to perform at least one OCT run before and one OCT run at the end of PCI. The operator is left free to review the OCT run in the console directly and is left free to perform during PCI any additional OCT run. Dedicated flow-chart of treatment should be followed by operator during PCI",[13],"Procedure: Percutaneous Coronary Intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"Angio arm (Group 2)","PCI of ISR guided by angiography (group 2): in this case, the operator has to perform PCI following angiography. To allow outcome computation, OCT will also be performed in this group at the beginning and the end of PCI, although the operator will be wholly blinded to any OCT findings. A detailed description of the blinding modality is reported in the following paragraph.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Percutaneous Coronary Intervention","Using OCT to guide PCI in ISR",[15,9],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Enrico Cerrato, MD, PhD","CONTACT","+393479317104","enricocerrato@gmail.com",[32,52,65,79,96,110,127,141,156,171,184,198],{"facility":33,"status":34,"city":35,"state":35,"zip":24,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Osp Aosta","RECRUITING","Aosta","Italy","IT",{"type":39,"coordinates":40},"Point",[41,42],7.31722,45.73764,{"lat":42,"lon":41},[45,49,50],{"name":46,"role":28,"phone":47,"phoneExt":24,"email":48},"Alessandro Bernardi, MD","0165 5431","alessandro.bernardi4@gmail.com",{"name":46,"role":28,"phone":24,"phoneExt":24,"email":24},{"name":51,"role":28,"phone":24,"phoneExt":24,"email":24},"Tarek Shail, MD",{"facility":53,"status":34,"city":53,"state":53,"zip":24,"country":36,"countryCode":37,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Biella",{"type":39,"coordinates":55},[56,57],8.05796,45.56304,{"lat":57,"lon":56},[60,64],{"name":61,"role":28,"phone":62,"phoneExt":24,"email":63},"Monica Verdoia, MD","0039 015 15151","monica.verdoia@gmail.com",{"name":61,"role":28,"phone":24,"phoneExt":24,"email":24},{"facility":66,"status":34,"city":67,"state":67,"zip":24,"country":36,"countryCode":37,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Osp. S. Croce e Carle","Cuneo",{"type":39,"coordinates":69},[70,71],7.54828,44.39071,{"lat":71,"lon":70},[74,78],{"name":75,"role":28,"phone":76,"phoneExt":24,"email":77},"Francesco Maiellaro, MD","0171 641048","francescomll91@gmail.com",{"name":75,"role":28,"phone":24,"phoneExt":24,"email":24},{"facility":80,"status":34,"city":81,"state":82,"zip":24,"country":36,"countryCode":37,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Ospedale Universitario di Ferrara","Cona","Ferrara",{"type":39,"coordinates":84},[85,86],11.7069,44.80583,{"lat":86,"lon":85},[89,93,94],{"name":90,"role":28,"phone":91,"phoneExt":24,"email":92},"Andrea Erriquez, MD","0532 236111","andrea.erriquez90@gmail.com",{"name":90,"role":28,"phone":24,"phoneExt":24,"email":24},{"name":95,"role":28,"phone":24,"phoneExt":24,"email":24},"Simone Biscaglia, MD",{"facility":97,"status":34,"city":98,"state":98,"zip":24,"country":36,"countryCode":37,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Osp Universitario S. Marino","Genova",{"type":39,"coordinates":100},[101,102],11.87211,45.21604,{"lat":102,"lon":101},[105,109],{"name":106,"role":28,"phone":107,"phoneExt":24,"email":108},"Rocco Vergallo, MD","010 5551","rocco.vergallo@gmail.com",{"name":106,"role":28,"phone":24,"phoneExt":24,"email":24},{"facility":111,"status":34,"city":112,"state":36,"zip":113,"country":36,"countryCode":37,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Infermi Hospital, Rivoli ASLTO3","Rivoli","10100",{"type":39,"coordinates":115},[116,117],7.51465,45.07073,{"lat":117,"lon":116},[120,124,125],{"name":121,"role":28,"phone":122,"phoneExt":24,"email":123},"Ferdinando Varbella, MD","0119551111","varbella@gmail.com",{"name":121,"role":28,"phone":24,"phoneExt":24,"email":24},{"name":126,"role":28,"phone":24,"phoneExt":24,"email":24},"Simone Zecchino, MD",{"facility":128,"status":34,"city":129,"state":129,"zip":24,"country":36,"countryCode":37,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Ospedale di Trapani","Trapani",{"type":39,"coordinates":131},[132,133],12.53617,38.0176,{"lat":133,"lon":132},[136,140],{"name":137,"role":28,"phone":138,"phoneExt":24,"email":139},"Dario Buccheri, MD","0923 809111","dariobuccheri@gmail.com",{"name":137,"role":28,"phone":24,"phoneExt":24,"email":24},{"facility":142,"status":34,"city":143,"state":144,"zip":113,"country":36,"countryCode":37,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"AOU San Luigi Gonzaga","Orbassano","Turin",{"type":39,"coordinates":146},[147,148],7.53813,45.00547,{"lat":148,"lon":147},[151,155],{"name":152,"role":28,"phone":153,"phoneExt":24,"email":154},"Enrico Cerrato, MD PhD","00390119026803","enrico.cerrato@gmail.com",{"name":152,"role":28,"phone":24,"phoneExt":24,"email":24},{"facility":157,"status":34,"city":144,"state":144,"zip":113,"country":36,"countryCode":37,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"AO Mauriziano",{"type":39,"coordinates":159},[160,161],7.68682,45.07049,{"lat":161,"lon":160},[164,168,169],{"name":165,"role":28,"phone":166,"phoneExt":24,"email":167},"Gianmarco Annibali, MD","+39 3290222215","gianmarco.annibali@gmail.com",{"name":165,"role":28,"phone":24,"phoneExt":24,"email":24},{"name":170,"role":28,"phone":24,"phoneExt":24,"email":24},"Giorgio Quadri, MD",{"facility":172,"status":34,"city":144,"state":144,"zip":113,"country":36,"countryCode":37,"cosmosGeoPoint":173,"geoPoint":175,"contacts":176},"AOU Città della Salute e della Scienza",{"type":39,"coordinates":174},[160,161],{"lat":161,"lon":160},[177,181,182],{"name":178,"role":28,"phone":179,"phoneExt":24,"email":180},"Ovidio De Filippo, MD","00390116330063","ovidio.defilippo@gmail.com",{"name":178,"role":28,"phone":24,"phoneExt":24,"email":24},{"name":183,"role":28,"phone":24,"phoneExt":24,"email":24},"Fabrizio D'Ascenzo, MD",{"facility":185,"status":34,"city":144,"state":186,"zip":113,"country":36,"countryCode":37,"cosmosGeoPoint":187,"geoPoint":189,"contacts":190},"Osp. Giovanni Bosco","TURIN",{"type":39,"coordinates":188},[160,161],{"lat":161,"lon":160},[191,195,196],{"name":192,"role":28,"phone":193,"phoneExt":24,"email":194},"Mario Iannaccone, MD","0039011 240 2210","mario.iannaccone@hotmail.it",{"name":192,"role":28,"phone":24,"phoneExt":24,"email":24},{"name":197,"role":28,"phone":24,"phoneExt":24,"email":24},"Francesco Colombo, MD",{"facility":199,"status":34,"city":200,"state":200,"zip":24,"country":36,"countryCode":37,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"Osp Vercelli","Vercelli",{"type":39,"coordinates":202},[203,204],8.41989,45.32163,{"lat":204,"lon":203},[207,211,212,214],{"name":208,"role":28,"phone":209,"phoneExt":24,"email":210},"Chiara Cavallino, MD","0161-593111","cavallino.c@gmail.com",{"name":208,"role":28,"phone":24,"phoneExt":24,"email":24},{"name":213,"role":28,"phone":24,"phoneExt":24,"email":24},"Mohamed Abdirashid, MD",{"name":215,"role":28,"phone":24,"phoneExt":24,"email":24},"Marco Franzino, MD",{"type":217,"investigatorFullName":218,"investigatorTitle":219,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Enrico Cerrato","Principal Investigator, Medical Doctor","100575963","intracoronary-optical-coherence-tomography-guidance-vs-angiography-only-guidance-for-treatment-of-coronary-in-stent-restenosis-100575963",false,"NCT06779110","Intracoronary Optical Coherence Tomography Guidance Vs. Angiography Only Guidance for Treatment of Coronary In-stent Restenosis","IN-Stent RestenosIs Detection and TrEtment by Optical Coherence Tomography","INSIDE OCT","Inclusion Criteria:\n\n* Informed consent signed\n* Age ≥ 18 years\n* Referred for angiography either in stable or ACS setting suitability for PCI through femoral or radial access\n* A coronary in-stent restenosis between 70% and 99% in at least two projections in a vessel with a lumen diameter ≥ 2.25 - ≤ 5.75 mm (The severity of the stenosis should be based on visual estimation, with current online state-of-the-art angiographic equipment of the participating centres and after a mandatory dose of 50-200 mcg intracoronary of nitroglycerine.\n* Stable hemodynamics\n\nExclusion Criteria:\n\n* Inability to give informed consent\n* Participation in another clinical study with an investigational product\n* OCT pullback not technically feasible in vessel site","ALL","18 Years","99 Years",{"count":232,"type":233},360,"ESTIMATED","INTERVENTIONAL",[236],"NA","Although advances in drug-eluting stents (DES) have substantially reduced the risk of coronary in-stent restenosis (ISR) and the need for target lesion revascularisation (TLR), ISR persists. There are several treatment options for ISR (conventional balloon angioplasty, cutting or scoring balloons, drug-coated balloons, repeat DES implantation or bypass surgery). Coronary imaging is mandatory to perform PCI on ISR. Optimal coherence tomography (OCT) is an excellent option to guide PCI, but its role in ISR-PCI remains unclear. The INSIDE OCT Trial aims to compare the acute performance of PCI for ISR, either guided by OCT and angiography or by angiography alone.",[239,240,241],"Coronary Artery Disease","Stent Restenosis","STENT",[243,244],"Percutaneous Coronary Intervention (PCI)","Optimal Coherence Tomography (OCT)","2025-01-12",{"date":247,"type":248},"2025-01-16","ACTUAL",{"date":250,"type":248},"2024-09-01",{"date":252,"type":233},"2028-09-01",{"name":5,"class":6},12]