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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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)
5. Participating in a conflicting study being undertaken during the PCI
Primary outcome measure(s)
Primary Endpoint — 90 Days 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.
Trial sites (1)
Facility
City
Region
Status
Wellstar Health System
Marietta
Georgia
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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