[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655474":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":30,"studyPopulation":34,"armGroups":30,"interventions":30,"overallOfficials":30,"centralContacts":35,"locations":30,"responsibleParty":41,"collaborators":30,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":30,"enrollmentInfo":55,"targetDuration":30,"studyType":58,"phases":30,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":69,"whyStopped":30,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":30},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Difference in CT-μFR","The change in non-invasive CT-μFR between post-procedure and 9-month follow-up within the treated coronary segment treated with DCB.","From baseline to 9 month follow-up.",[14,17,20,23,27],{"measure":15,"description":16,"timeFrame":12},"Late lumen loss (LLL)","Late lumen loss (LLL) in mm in the target lesion measured on CCTA between post-procedure and at 9-month follow-up.",{"measure":18,"description":19,"timeFrame":12},"Change in Minimal Lumen Area (MLA)","Change in Minimal Lumen Area (MLA) in mm² in the target lesion measured on CCTA between post-procedure and at 9-month follow-up.",{"measure":21,"description":22,"timeFrame":12},"Change in Plaque Burden (PB)","Change in Percent Plaque Burden (PB) in the target lesion measured on CCTA be tween post-procedure and at 9-month follow-up.",{"measure":24,"description":25,"timeFrame":26},"Clinical outcomes","MACE, TLR, and BARC-3 or 5 bleeding (according to the Bleeding ARC) at 1-month, 1-year, 3-years and 5-years follow-up.","From baseline to 5 years follow-up.",{"measure":28,"description":29,"timeFrame":12},"Correlations between CCTA-derived measurements","Correlation between (change in) LLL\u002FMLA\u002FPB and (change in) non-invasive CT-μFR.",null,{"allocation":30,"interventionModel":30,"interventionModelDescription":30,"primaryPurpose":30,"observationalModel":32,"timePerspective":33,"maskingInfo":30},"COHORT","PROSPECTIVE","Consecutive patients aged 18 years or older scheduled for PCI of a native coronary artery will be screened for inclusion in the trial. Patients will be included at the Amsterdam UMC.",[36],{"name":37,"role":38,"phone":39,"phoneExt":30,"email":40},"Inge T Bosch","CONTACT","+31 20 566 6603","i.t.bosch@amsterdamumc.nl",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Bimmer Claessen","Interventional Cardiologist, Department of Cardiology","100655474","non-invasive-follow-up-of-patients-with-coronary-artery-disease-treated-with-drug-coated-balloon-pci-using-ct-derived-fractional-flow-reserve-100655474",false,"NCT07811960","Non-Invasive Follow-Up of Patients With Coronary Artery Disease Treated With Drug-Coated Balloon PCI Using CT-Derived Fractional Flow Reserve","Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons Computed-Tomography Fractional Flow Reserve Sub-Study","RECORD-CT-FFR","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Presence of a de novo lesion;\n* Successful DCB-PCI of a native coronary artery or major side branch.\n\nExclusion Criteria:\n\n* No Protégé DCB was used;\n* Previous CABG;\n* Ineligibility for CCTA acquisition due to:\n\n  * Known renal insufficiency, i.e. eGFR ≤ 30 mL\u002Fmin\u002F1.73m²;\n  * Known hypersensitivity or contraindication to CT contrast agents;\n  * Body weight \\> 150 kg.\n* Metallic implants in or around the target vessel;\n* Pregnancy or pregnancy status unknown;\n* Presence of a comorbid condition with a life expectancy of less than one year;\n* Inability to provide informed consent","ALL","18 Years",{"count":56,"type":57},150,"ESTIMATED","OBSERVATIONAL","This study investigates changes in coronary artery anatomy and physiology after treatment with a paclitaxel drug-coated balloon (DCB) during percutaneous coronary intervention (PCI). Unlike conventional stenting, DCB treatment delivers an antiproliferative drug to the vessel wall without leaving a permanent metallic implant. The absence of a permanent implant allows non-invasive assessment of the treated coronary artery during follow-up using coronary CT angiography (CCTA).\n\nParticipants will undergo two CCTA examinations: an early scan within two weeks after PCI and a follow-up scan after nine months. CT-derived fractional flow reserve (CT-μFR) will be calculated from both scans to assess changes in μFR of the treated coronary artery over time. CCTA will also be used to evaluate changes in coronary plaque and vessel characteristics.\n\nThe primary objective is to determine whether CT-μFR changes between early and nine-month follow-up after DCB-PCI. Secondary objectives include evaluating changes in plaque and vessel characteristics on CCTA and assessing clinical outcomes during follow-up.",[61,62,63],"Coronary Arterial Disease (CAD)","Acute Coronary Syndromes (ACS)","Stable Coronary Artery Disease Undergoing PCI",[65,66,67,68],"drug coated balloon","Non-invasive follow-up","Coronary Computed Tomography Angiography (CCTA)","CT-derived FFR","NOT_YET_RECRUITING","2026-09-14",{"date":72,"type":73},"2026-09-16","ACTUAL",{"date":75,"type":57},"2026-09",{"date":77,"type":57},"2033-09",{"name":5,"class":6}]