[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637529":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":26,"responsibleParty":44,"collaborators":26,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":26,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":72,"overallStatus":75,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":81,"leadSponsor":83,"locationsCount":26},{"fullName":5,"class":6},"University of Galway","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CCTA-Guided PCI","EXPERIMENTAL","Participants randomized to this arm will undergo percutaneous coronary intervention (PCI) guided by a structured coronary computed tomography angiography (CCTA)-based virtual procedural planning strategy. Pre-procedural centralized CCTA analysis will provide information regarding lesion morphology, vessel dimensions, lesion length, calcium distribution, bifurcation anatomy, optimal angiographic projections, and CT-derived functional assessment. Operators will use this information during PCI planning and execution to guide lesion preparation, device selection, stent sizing, and procedural strategy.",[13],"Procedure: CCTA-Guided Percutaneous Coronary Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard PCI","ACTIVE_COMPARATOR","Participants randomized to this arm will undergo PCI according to standard clinical practice and operator discretion without access to the advanced CCTA-derived virtual procedural planning. Operators may use additional intravascular imaging, physiological assessment, or adjunctive devices according to routine practice. The CCTA-based procedural planning generated by the core laboratory will remain concealed from operators throughout the procedure.",[19],"Procedure: Standard Percutaneous Coronary Intervention",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","CCTA-Guided Percutaneous Coronary Intervention","Participants undergo percutaneous coronary intervention (PCI) guided by a structured coronary computed tomography angiography (CCTA)-based virtual procedural planning workflow. Pre-procedural centralized CCTA analysis provides information regarding lesion morphology, vessel dimensions, lesion length, calcium burden, bifurcation anatomy, optimal angiographic projections, and CT-derived fractional flow reserve to support procedural planning and PCI optimization.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard Percutaneous Coronary Intervention","Participants undergo PCI according to standard clinical practice and operator discretion without access to the advanced CCTA-derived virtual procedural planning. Operators may use intravascular imaging, physiological assessment, and adjunctive devices according to routine practice and guideline-based care.",[15],[32],{"name":33,"affiliation":5,"role":34},"Faisal Sharif, MBBS, PhD, FRCPI, FESC, FACC","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+353 91524222","faisal.sharif@universityofgalway.ie",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},"Eileen Coen, CNM","+353 86 145 5568","eileen.coen@universityofgalway.ie",{"type":34,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Faisal Sharif","Prof. Faisal Sharif","100637529","computed-tomography-angiography-based-procedural-planning-in-percutaneous-coronary-intervention-100637529",false,"NCT07592312","Computed Tomography Angiography Based Procedural Planning in PeRcutaneOus Coronary InterVEntion","CT-PROVE: Computed Tomography Angiography Based Procedural Planning in PeRcutaneOus Coronary InterVEntion","CT-PROVE","Inclusion Criteria:\n\n* Adults aged 18 to 80 years\n* Ability to provide written informed consent\n* Patients undergoing coronary computed tomography angiography (CCTA) for suspected coronary artery disease or for diagnostic work-up of stabilized acute coronary syndrome\n* Presence of at least one target coronary lesion meeting one of the following CCTA criteria:\n\n  * Severe coronary diameter stenosis (70-99%) in one or more coronary arteries according to CAD-RADS 4A or 4B classification and at least one of the following:\n  * CT-derived fractional flow reserve (CT-FFR) ≤0.80\n  * At least 2 high-risk plaque characteristics, including:\n  * Low attenuation plaque density \\\u003C30 Hounsfield units\n  * Positive remodeling index \\>1.1\n  * Napkin-ring sign\n  * Spotty calcification\n  * Left main coronary artery stenosis ≥50%\n  * Ostial or proximal left anterior descending artery, dominant left circumflex artery, or dominant right coronary artery stenosis ≥50% and at least one of the following:\n  * CT-FFR ≤0.80\n  * At least 2 high-risk plaque characteristics, including:\n  * Low attenuation plaque density \\\u003C30 Hounsfield units\n  * Positive remodeling index \\>1.1\n  * Napkin-ring sign\n  * Spotty calcification\n* Planned clinically indicated invasive coronary angiography with operator decision to proceed with PCI\n\nExclusion Criteria:\n\n* Contraindication to iodinated contrast media, including severe allergy or contrast-induced nephropathy\n* Poor-quality or non-diagnostic CCTA imaging\n* Target lesions involving in-stent restenosis\n* Chronic total occlusion target lesions\n* Operator decision to treat a vessel not identified as a target vessel by the CCTA core laboratory analysis\n* Pregnancy or breastfeeding\n* Patients referred for coronary artery bypass graft surgery after invasive coronary angiography\n* Participation in another investigational drug or drug-coated device study\n* Inability to provide informed consent","ALL","18 Years","80 Years",{"count":59,"type":60},200,"ESTIMATED","INTERVENTIONAL",[63],"NA","The goal of this clinical trial is to learn whether coronary CT angiography (CCTA)-guided planning improves the efficiency and outcomes of percutaneous coronary intervention (PCI) in adults with coronary artery disease. It will also evaluate the feasibility and safety of using a CT-based \"virtual PCI plan\" during coronary interventions.\n\nThe main questions it aims to answer are:\n\n* Does CCTA-guided PCI reduce procedural time, radiation exposure, and contrast dye use compared with standard PCI?\n* Does CCTA-guided PCI improve procedural outcomes and stent optimization?\n* How often do operators follow or deviate from the CT-based procedural plan?\n* What medical problems or complications occur during and after CCTA-guided PCI?\n\nResearchers will compare CCTA-guided PCI with standard angiography-guided PCI to determine whether CT-derived procedural planning improves PCI efficiency and clinical outcomes.\n\nParticipants will:\n\n* Undergo PCI guided either by a CCTA-based virtual planning strategy or by standard clinical practice\n* Attend follow-up assessments at 1 month, 6 months, and 1 year\n* Undergo routine clinical evaluations and imaging assessments related to their PCI procedure\n* Be monitored for procedural complications, symptoms, repeat procedures, and cardiovascular outcomes during follow-up\n\nThe study will also include a parallel observational registry for patients whose coronary lesions are deferred from PCI, to evaluate their long-term clinical outcomes.",[66,67,68,69,70,71],"Coronary Arteries Disease","Chronic Coronary Syndrome","Acute Coronary Syndromes (ACS)","Myocardial Ischemia","Percutaneous Coronary Intervention","Coronary Computed Tomography Angiography",[73,74,70,71],"Coronary Artery Disease","Chronic Coronary Disease","NOT_YET_RECRUITING","2026-05-13",{"date":78,"type":79},"2026-05-18","ACTUAL",{"date":78,"type":60},{"date":82,"type":60},"2028-12-30",{"name":5,"class":6}]