Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:17 AM
Study NCT ID:
NCT07479433
Status:
RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The NAVIGATE-PCI Registry: A New Approach to VIew CT-derived Guidance Ahead of Stenting To Plan Efficient PCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-11', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory and Safety Endpoint', 'timeFrame': '5 years', 'description': 'Perform all endpoint analyses with a comparison of male vs. female as an added variable'}, {'measure': 'Exploratory and Safety Endpoint', 'timeFrame': '5 years', 'description': 'Procedural complications and in-hospital outcomes'}], 'primaryOutcomes': [{'measure': 'Primary Endpoint', 'timeFrame': '90 Days', 'description': 'The primary endpoint will be assessed only in Group 2 and is a change in procedural plan following review of the information provided by PCI Navigator compared to procedural plan with angiographic imaging alone.\n\nThe primary endpoint will be measured by calculating the percentage of patients in whom a change of plan was documented following review of the PCI Navigator tool compared to the plan documented prior to using the tool.'}], 'secondaryOutcomes': [{'measure': 'Changes in confidence with and without PCI Navigator (assessed in Groups 2 and 3 as two separate analyses)', 'timeFrame': '90 days for Group 2, 18 months for Group 3'}, {'measure': 'Change in procedural time with and without PCI Navigator', 'timeFrame': '90 days'}, {'measure': 'Change in contrast usage with and without PCI Navigator', 'timeFrame': '90 days'}, {'measure': 'Change in radiation usage during PCI with and without PCI Navigator', 'timeFrame': '90 days'}, {'measure': 'Change in invasive imaging (angiographic or other) with and without PCI Navigator', 'timeFrame': '90 days'}, {'measure': 'Change in resource utilization with and without PCI Navigator', 'timeFrame': '90 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['CAD', 'PCI Navigator', 'CT-Guided PCI', 'PCI'], 'conditions': ['Coronary Artery Disease (CAD)']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "Heartflow's NAVIGATE-PCI Registry is a post-market, multi-center, data collection registry assessing confidence in procedure planning, time of procedure, contrast usage during procedure, radiation usage during procedure, invasive imaging (angiographic or other), and resource utilization. Sites will provide retrospective data from patients receiving an elective PCI prior to the deployment of PCI Navigator vs. after deployment and operator training on how to use the information provided by PCI Navigator. Baseline demographic, medical history, procedural, and in-hospital outcome information will be collected following the procedure. No post discharge follow-up data will be collected."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Deidentified data will be collected for all patients included in the registry who had a CCTA with acceptable image quality prior to elective PCI and are included by the site in the registry. Patients with prior CABG or patients with intervention planned in a previously stented vessel territory are excluded.', 'healthyVolunteers': False, 'eligibilityCriteria': "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"}, 'identificationModule': {'nctId': 'NCT07479433', 'acronym': 'NAVIGATE-PCI', 'briefTitle': 'The NAVIGATE-PCI Registry: A New Approach to VIew CT-derived Guidance Ahead of Stenting To Plan Efficient PCI', 'organization': {'class': 'INDUSTRY', 'fullName': 'HeartFlow, Inc.'}, 'officialTitle': 'The NAVIGATE-PCI Registry: A New Approach to VIew CT-derived Guidance Ahead of Stenting To Plan Efficient PCI', 'orgStudyIdInfo': {'id': 'CP-911-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1: No PCI Navigator', 'description': "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': 'Group 2: Intraprocedural PCI Planning', 'description': '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.', 'interventionNames': ['Diagnostic Test: Heartflow PCI Navigator']}, {'label': 'Group 3: Preprocedural Planning', 'description': '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.', 'interventionNames': ['Diagnostic Test: Heartflow PCI Navigator']}], 'interventions': [{'name': 'Heartflow PCI Navigator', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Group 2: Intraprocedural PCI Planning', 'Group 3: Preprocedural Planning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Frank Corrigan, MD', 'role': 'CONTACT', 'email': 'Frank.Corrigan@wellstar.org', 'phone': '470-793-4034'}], 'facility': 'Wellstar Health System', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}], 'centralContacts': [{'name': 'Abby Doctolero', 'role': 'CONTACT', 'email': 'adoctolero@heartflow.com', 'phone': '650-241-1221'}, {'name': 'Sarah Mullen', 'role': 'CONTACT', 'email': 'smullen@heartflow.com', 'phone': '650-241-1221'}], 'overallOfficials': [{'name': 'Ziad Ali, MD, DPhil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Francis Hospital & Heart Center Columbia University'}, {'name': 'Todd C. Villines, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HeartFlow, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}