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

NCT07479433 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2026-03-23

No results posted yet for this 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.

Conditions

  • Coronary Artery Disease (CAD)

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • HeartFlow, Inc.

    lead INDUSTRY

Principal Investigators

  • Ziad Ali, MD, DPhil · St. Francis Hospital & Heart Center Columbia University

  • Todd C. Villines, MD · University of Virginia

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-11
Primary Completion
2026-09-30
Completion
2032-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07479433 on ClinicalTrials.gov