[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531900":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":24,"studyPopulation":28,"armGroups":24,"interventions":24,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":60,"collaborators":62,"id":65,"slug":24,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":24,"enrollmentInfo":74,"targetDuration":77,"studyType":78,"phases":24,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":42,"whyStopped":24,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"CoreAalst BV","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"assess the accuracy of CCTA to quantify total atheroma volume (TAV) with IVUS as reference.","To assess the accuracy of CCTA (Coronary Computed Tomography Angiography) to quantify total atheroma volume (TAV) with IVUS (Intravascular Ultrasound) as reference.","day 0 (day of the procedure)",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Assess the accuracy of CCTA to determine minimal stent area with IVUS as reference.","To assess the accuracy of CCTA (Coronary Computed Tomography Angiography) to determine minimal stent area with IVUS (Intravascular Ultrasound) as reference.",{"measure":18,"description":19,"timeFrame":12},"Determine the diagnostic performance (mean difference) of FFRCT in stented segments with invasive FFR as reference.","To determine the diagnostic performance (mean difference) of FFRCT (Fractional Flow Reserve derived from CT) in stented segments with invasive FFR (Fractional Flow Reserve ) as reference.",{"measure":21,"description":22,"timeFrame":23},"Describe the impact of coronary microvascular dysfunction assessed by IMR and absolute coronary resistance on the accuracy of FFRCT.","To describe the impact of coronary microvascular dysfunction assessed by IMR (Index of Microcirculatory Resistance) and absolute coronary resistance on the accuracy of FFRCT (Fractional Flow Reserve derived from CT).","day 0 (day of the procedure",null,{"allocation":24,"interventionModel":24,"interventionModelDescription":24,"primaryPurpose":24,"observationalModel":26,"timePerspective":27,"maskingInfo":24},"COHORT","PROSPECTIVE","Patients with Coronary Artery Disease with an epicardial stenosis of more than 50% of visual assessment.",[30],{"name":31,"affiliation":32,"role":33},"Eric Wyffels, MD, PhD","OLV Hospital Aalst","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":24,"email":39},"Sofie Pardaens, MSc, PhD","CONTACT","0032 53 72 42 30","sofiepardaens@coreaalst.com",[41],{"facility":32,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Aalst","Oost-Vlaanderen","9300","Belgium","BE",{"type":49,"coordinates":50},"Point",[51,52],4.0355,50.93604,{"lat":52,"lon":51},[55,59],{"name":56,"role":37,"phone":57,"phoneExt":24,"email":58},"Hilde Delacroix","053724449","hilde.delacroix@olvz-aalst.be",{"name":31,"role":33,"phone":24,"phoneExt":24,"email":24},{"type":61,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[63],{"name":64,"class":6},"HeartFlow, Inc.","100531900",false,"NCT06205810","The COMPLETE Study","Comprehensive Anatomical and Physiological Evaluation of Patients With Stable Coronary Artery Disease.","COMPLETE","Inclusion Criteria:\n\n1\\. Epicardial stenosis more than 50% by visual assessment.\n\nExclusion Criteria:\n\n1. STEMI.\n2. Hemodynamic instability.\n3. Rapid atrial fibrillation, flutter or arrhythmia (HR \\> 80 bpm).\n4. Insufficient CCTA image quality.\n5. Age \\\u003C18 years.\n6. Chronic obstructive pulmonary disease.\n7. Contraindication to adenosine.\n8. NYHA class III or IV, or last known left ventricular ejection fraction \\\u003C30%.\n9. Uncontrolled or recurrent ventricular tachycardia.\n10. History of recent stroke (≤90 days).\n11. Prior myocardial infarction.\n12. History of ischemic stroke (\\>90 days) with modified RANKIN score ≥ 2.\n13. History of any hemorrhagic stroke.\n14. Previous coronary artery bypass surgery.\n15. Active liver disease or hepatic dysfunction, defined as AST or ALT \\> 3 times the ULN.\n16. Severe renal dysfunction, defined as an eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2.\n17. BMI \\>35 kg\u002Fm2.\n18. Nitrate intolerance\n19. Contra-indication to heart rate lowering drugs.\n20. Unable to provide written informed consent.","ALL","18 Years",{"count":75,"type":76},250,"ESTIMATED","3 Years","OBSERVATIONAL","The COMPLETE study is a single-centre, investigator-initiated study of patients with an indication for invasive coronary angiography with CCTA performed during the diagnostic evaluation. After identifying the presence of a coronary stenosis, defined as an epicardial lesion \\>50% stenosis on CCTA, patients eligible for the study will be invited to participate.\n\nThe main aim of this trial is to assess the accuracy of coronary CT angiography to quantify total atheroma volume with intravascular ultrasound as reference.\n\nPatients will be divided into 2 sub-groups:\n\nCohort 1: Patients with stable coronary artery disease or stabilized acute coronary syndromes with a clinical indication for invasive coronary angiography.\n\nCohort 2: Patients previously revascularized with a metallic stent with a clinical indication for invasive coronary angiography.\n\nIn both cohorts, patients should have undergone coronary CT angiography as part of the standard of care.\n\nPatients included in the study will be managed according to the standard of care for the assessment of coronary artery disease. Clinical follow-up will be collected until 3 years follow-up.",[81],"Coronary Artery Disease",[83],"FFRCT","2026-01-16",{"date":86,"type":87},"2026-01-20","ACTUAL",{"date":89,"type":87},"2023-10-24",{"date":91,"type":76},"2031-10-15",{"name":5,"class":6},1]