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.
CCTA completed ≤90 days prior to elective PCI with acceptable image quality according to Heartflow's image quality requirements
Referred for elective PCI
Clinically stable without symptoms suggestive of acute coronary syndrome (ACS) at the time of the intervention
ED presentation (at the time of the referral for PCI)
Previous coronary artery bypass graft (CABG)
Planned intervention in a previously stented vessel territory
Acute chest pain (in patients who have not been ruled out for ACS)
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.
Cohort
Cross-sectional
Heartflow PCI Navigator
Diagnostic testHeartflow 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.
Primary Endpoint
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. The 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.
Changes in confidence with and without PCI Navigator (assessed in Groups 2 and 3 as two separate analyses)
Change in procedural time with and without PCI Navigator
Change in contrast usage with and without PCI Navigator
Change in radiation usage during PCI with and without PCI Navigator
Exploratory and Safety Endpoint
Perform all endpoint analyses with a comparison of male vs. female as an added variable
Exploratory and Safety Endpoint
Procedural complications and in-hospital outcomes
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