The NAVIGATE-PCI Registry: A New Approach to VIew CT-derived Guidance Ahead of Stenting To Plan Efficient PCI
HeartFlow, Inc.
Summary
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria (all must be present): 1. CCTA completed ≤90 days prior to elective PCI with acceptable image quality according to Heartflow's image quality requirements 2. Referred for elective PCI 3. Clinically stable without symptoms suggestive of acute coronary syndrome (ACS) at the time of the intervention Exclusion Criteria (all must be present): 1. ED presentation (at the time of the referral for PCI) 2. Previous coronary artery bypass graft (CABG) 3. Planned intervention in a previously stented vessel territory 4. Acute chest pain (in patients who have not been ruled out for ACS)…
Interventions
- Diagnostic TestHeartflow 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.
Location
- Wellstar Health SystemMarietta, Georgia