[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629804":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":35,"locations":44,"responsibleParty":64,"collaborators":10,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":10,"enrollmentInfo":75,"targetDuration":78,"studyType":79,"phases":10,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":47,"whyStopped":10,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"HeartFlow, Inc.","INDUSTRY",[8,12,17],{"label":9,"type":10,"description":11,"interventionNames":10},"Group 1: No PCI Navigator",null,"This group includes consecutive patients who have undergone a CCTA a maximum of 90 days prior to an elective PCI at the study site; the CCTA is not required to have been used in procedural planning but must have acceptable image quality according to Heartflow's image quality requirements",{"label":13,"type":10,"description":14,"interventionNames":15},"Group 2: Intraprocedural PCI Planning","This group includes patients who had a CCTA and a referral for elective PCI following the introduction of the PCI Navigator at the study site. The PCI should be performed no more than 90 days following the CCTA. Interventionalists will document their procedural plan after initial invasive angiographic images are reviewed but before reviewing the information provided by the PCI Navigator, and then again after reviewing the information provided by the PCI Navigator. Usage of invasive imaging following review of the PCI Navigator is at the discretion of the interventionalist.",[16],"Diagnostic Test: Heartflow PCI Navigator",{"label":18,"type":10,"description":19,"interventionNames":20},"Group 3: Preprocedural Planning","This group includes patients who had a CCTA and a referral for elective PCI following the introduction of the PCI Navigator at the study site. The PCI should be performed no more than 90 days following the CCTA. Interventionalists will document their procedural plan before reviewing the information provided by the PCI Navigator and prior to initial invasive angiographic imaging, and then again after reviewing the information provided by the PCI Navigator. Usage of angiographic and other invasive imaging following review of the PCI Navigator is at the discretion of the interventionalist.",[16],[22],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"DIAGNOSTIC_TEST","Heartflow PCI Navigator","Heartflow PCI Navigator is the only integrated, AI-driven PCI planning tool that gives interventional cardiologists a patient-specific 3D model, detailing anatomy, plaque composition, and lesion-specific physiology, all aligned to optimize potential stent placement. PCI Navigator delivers a streamlined view of essential information for cath lab decision-making by integrating all relevant measurements, including IVUS-like and FFR-like pullback visualizations, into one seamless experience, which typically requires significant time and effort to obtain in the cath lab.",[13,18],[28,32],{"name":29,"affiliation":30,"role":31},"Ziad Ali, MD, DPhil","St. Francis Hospital & Heart Center Columbia University","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":34,"role":31},"Todd C. Villines, MD","University of Virginia",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":10,"email":40},"Abby Doctolero","CONTACT","650-241-1221","adoctolero@heartflow.com",{"name":42,"role":38,"phone":39,"phoneExt":10,"email":43},"Sarah Mullen","smullen@heartflow.com",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Wellstar Health System","RECRUITING","Marietta","Georgia","30060","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-84.54993,33.9526,{"lat":57,"lon":56},[60],{"name":61,"role":38,"phone":62,"phoneExt":10,"email":63},"Frank Corrigan, MD","470-793-4034","Frank.Corrigan@wellstar.org",{"type":65,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100629804","the-navigate-pci-registry-a-new-approach-to-view-ct-derived-guidance-ahead-of-stenting-to-plan-efficient-pci-100629804",false,"NCT07479433","The NAVIGATE-PCI Registry: A New Approach to VIew CT-derived Guidance Ahead of Stenting To Plan Efficient PCI","NAVIGATE-PCI","Inclusion Criteria (all must be present):\n\n1. CCTA completed ≤90 days prior to elective PCI with acceptable image quality according to Heartflow's image quality requirements\n2. Referred for elective PCI\n3. Clinically stable without symptoms suggestive of acute coronary syndrome (ACS) at the time of the intervention\n\nExclusion Criteria (all must be present):\n\n1. ED presentation (at the time of the referral for PCI)\n2. Previous coronary artery bypass graft (CABG)\n3. Planned intervention in a previously stented vessel territory\n4. Acute chest pain (in patients who have not been ruled out for ACS)\n5. Participating in a conflicting study being undertaken during the PCI","ALL","18 Years",{"count":76,"type":77},5000,"ESTIMATED","5 Years","OBSERVATIONAL","The objective of Heartflow's NAVIGATE-PCI Registry is to collect observational data about the management of patients before and after deployment of Heartflow's PCI Navigator.",[82],"Coronary Artery Disease (CAD)",[84,85,86,87],"CAD","PCI Navigator","CT-Guided PCI","PCI","2026-03-18",{"date":90,"type":91},"2026-03-23","ACTUAL",{"date":93,"type":91},"2026-03-11",{"date":95,"type":77},"2032-12-31",{"name":5,"class":6},1]