[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100422449":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":41,"studyPopulation":34,"armGroups":42,"interventions":48,"overallOfficials":60,"centralContacts":65,"locations":71,"responsibleParty":111,"collaborators":114,"id":118,"slug":34,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":119,"sex":124,"minAge":125,"maxAge":34,"enrollmentInfo":126,"targetDuration":34,"studyType":129,"phases":130,"briefSummary":131,"conditions":132,"keywords":135,"overallStatus":95,"whyStopped":34,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Isala","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":12,"otherOutcomes":34},[9],{"measure":10,"description":10,"timeFrame":11},"The AUC of post-PCI RFR compared to the AUC of post-PCI FFR with regard to SSR.","Index procedure (or staged procedure if indicated).",[13,16,19,22,24,26,28,32],{"measure":14,"description":14,"timeFrame":15},"Seattle Angina Questionnaire (SAQ) score at follow-up","4± 2 weeks",{"measure":17,"description":18,"timeFrame":15},"New York Heart Association (NYHA) classification at follow-up","New York Heart Association (NYHA) classification (I, II, III or IV) at follow-up",{"measure":20,"description":21,"timeFrame":15},"Canadian Cardiovascular Society (CCS) classification at follow-up","Canadian Cardiovascular Society (CCS) classification (I, II, III, IV) at follow-up",{"measure":23,"description":23,"timeFrame":15},"Occurrence of the composite endpoint of all-cause mortality, myocardial infarction and any coronary revascularization (MACE) at follow-up",{"measure":25,"description":25,"timeFrame":11},"The predictive value of the RFR and FFR gradient across the stented segment with regard to SSR in CTO patients.",{"measure":27,"description":27,"timeFrame":11},"The correlation between positive RFR (≤0.89) and positive FFR (≤0.80) with regard to SSR following angiographically satisfactory CTO PCI.",{"measure":29,"description":30,"timeFrame":31},"The correlation between post-PCI physiology (OCT, RFR, FFR, CFR, IMR) and suboptimal stent result (SSR) with anginal complaints (SAQ score), NYHA and CCS classification and MACE at follow-up","The correlation between post-PCI physiology (OCT, RFR, FFR, CFR, IMR) and suboptimal stent result (SSR) with anginal complaints (SAQ score), NYHA and CCS classification and MACE at follow-up.","Index procedure (or staged procedure if indicated) until 4± 2 weeks follow-up",{"measure":33,"description":33,"timeFrame":11},"The impact on physician-decision making based on OCT and physiology findings",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":38,"observationalModel":34,"timePerspective":34,"maskingInfo":39},"NA","SINGLE_GROUP","PREVENTION",{"masking":40,"maskingDescription":34,"whoMasked":34},"NONE","ULTRA-CTO is a prospective multicentre non-randomised investigator-initiated trial designed to enrol 200 subjects with an indication for PCI CTO.\n\nThe main objective of the study is to evaluate both the value of post-PCI RFR and post-PCI FFR for detecting suboptimal stent result (SSR).\n\nAfter angiographically successful CTO PCI, intra-coronary physiologic assessment (RFR, FFR, coronary flow reserve (CFR) and index of microcirculatory resistance (IMR)) of the CTO vessel will be performed. Additional OCT will be performed directly or during a staged procedure within 4 ± 2 weeks when indicated (i.e. high contrast use, procedural duration, major dissection or other safety reasons according to the operator).\n\nWhen intra-coronary physiologic assessment or OCT is not possible at all, the patients will not be included in the study.\n\nWhen the operator decides to optimize the stent result (post-dilation or additional stenting), based on the OCT and\u002For physiology, post-PCI RFR and FFR should be repeated. For patients undergoing a clinically indicated FFR of a remaining intermediate stenosis (angiographically 30-90%) in a non-CTO vessel or major side branch of the CTO vessel within 4 weeks after the index procedure, intra-coronary physiologic assessment (RFR, FFR, CFR and IMR) will be repeated in the CTO vessel for exploratory objectives\n\nAt 4 ± 2 weeks follow-up, the occurrence of cardiovascular events and clinical classification will be assessed for secondary objectives",[43],{"label":44,"type":6,"description":45,"interventionNames":46},"Post-PCI intra-coronary physiological and OCT measurements","After angiographically successful CTO PCI, intra-coronary physiologic assessment (RFR, FFR, CFR and IMR) and OCT of the CTO vessel will be performed directly. OCT may als be performed during a staged procedure within 4 ± 2 weeks after the index procedure when clinically indicated.",[47],"Diagnostic Test: post-PCI Pd\u002FPa",[49],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"DIAGNOSTIC_TEST","post-PCI Pd\u002FPa","After angiographically successful CTO PCI, intra-coronary physiologic assessment (RFR, FFR, CFR and IMR) and subsequent OCT of the CTO vessel will be performed. OCT may also be performed during a staged procedure when clinically indicated.",[44],[55,56,57,58,59],"Post-PCI RFR","Post-PCI CFR","Post-PCI IMR","Post-PCI FFR","Post-PCI OCT",[61],{"name":62,"affiliation":63,"role":64},"Maarten Van Leeuwen, PhD","Isala Zwolle","PRINCIPAL_INVESTIGATOR",[66],{"name":67,"role":68,"phone":69,"phoneExt":34,"email":70},"Maarten van Leeuwen, PhD","CONTACT","0031 38 424 2374","m.a.h.van.leeuwen@isala.nl",[72,94],{"facility":73,"status":74,"city":75,"state":34,"zip":34,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Radboud UMC","NOT_YET_RECRUITING","Nijmegen","Netherlands","NL",{"type":79,"coordinates":80},"Point",[81,82],5.85278,51.8425,{"lat":82,"lon":81},[85,88,91,92],{"name":86,"role":68,"phone":34,"phoneExt":34,"email":87},"Alexander Griffioen, MD, MSc","alexander.griffioen@radboudumc.nl",{"name":89,"role":68,"phone":34,"phoneExt":34,"email":90},"Robert Jan van Geuns, MD, PhD","robertjan.vangeuns@radboudumc.nl",{"name":89,"role":64,"phone":34,"phoneExt":34,"email":34},{"name":86,"role":93,"phone":34,"phoneExt":34,"email":34},"SUB_INVESTIGATOR",{"facility":5,"status":95,"city":96,"state":34,"zip":97,"country":76,"countryCode":77,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"RECRUITING","Zwolle","8025 AB",{"type":79,"coordinates":99},[100,101],6.09444,52.5125,{"lat":101,"lon":100},[104,106,109,110],{"name":105,"role":68,"phone":69,"phoneExt":34,"email":70},"Maarten Van Leeuwen, MD, PhD",{"name":107,"role":68,"phone":69,"phoneExt":34,"email":108},"Tom Meijers, MD, MSc","t.a.meijers@isala.nl",{"name":105,"role":64,"phone":34,"phoneExt":34,"email":34},{"name":107,"role":93,"phone":34,"phoneExt":34,"email":34},{"type":64,"investigatorFullName":112,"investigatorTitle":113,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Maarten van Leeuwen","Principial Investigator Isala",[115],{"name":116,"class":117},"Abbott","INDUSTRY","100422449",false,"NCT04780971","Use of Physiology to Evaluate Procedural Result After PCI CTO","ULTRA-CTO","Inclusion Criteria:\n\n1. Age 18 years and older.\n2. Angiographically successful PCI CTO without any remaining lesion at least 30% proximal to the stented segment.\n3. Possibility to perform physiologic measurements and OCT of sufficient quality.\n4. Patients willing and capable to provide written informed consent.\n\nExclusion Criteria:\n\n1\\) Contra-indication for adenosine.","ALL","18 Years",{"count":127,"type":128},200,"ESTIMATED","INTERVENTIONAL",[36],"ULTRA-CTO is a prospective multicentre non-randomised investigator-initiated trial designed to enrol 200 subjects with an indication for percutaneous coronary intervention (PCI) of chronic total occluded (CTO) coronary artery.\n\nThe main objective of the study is to assess the predictive value of post-PCI resting full-cycle ratio (RFR) and fractional flow reserve (FFR) with regard to Fractional flow reserve (SSR) in CTO patients.",[133,134],"Percutaneous Coronary Revascularisation","Complex Coronary Lesion",[136,137,138,139],"percutaneous coronary intervention","chronic total occlusion","intra-coronary physiology","optical coherence tomography","2025-02-15",{"date":142,"type":143},"2025-02-19","ACTUAL",{"date":145,"type":143},"2021-07-21",{"date":147,"type":128},"2026-06",{"name":5,"class":6},2]