NCT07479433Recruiting

The NAVIGATE-PCI Registry: A New Approach to VIew CT-derived Guidance Ahead of Stenting To Plan Efficient PCI

HeartFlow, Inc.

Start Date

3/11/2026

Completion Date

12/31/2032

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.

Detailed 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 be collected following the procedure. No post discharge follow-up data will be collected.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DIAGNOSTIC_TEST

Heartflow PCI Navigator

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Conditions

Coronary Artery Disease (CAD)

Locations

Wellstar Health System

Marietta, Georgia 30060

United States