NAVIGATE-PCI Registry for Coronary Artery Disease

This study, called the NAVIGATE-PCI Registry, is looking at how doctors use the Heartflow PCI Navigator before placing stents in patients with coronary artery disease (CAD). The Heartflow PCI Navigator is an AI-powered tool that creates a 3D model of your heart to help plan stent placement. Researchers want to see if using this tool changes how doctors plan procedures, how long procedures take, and how much contrast dye and radiation are used. You might be able to join if you are at least 18 years old, have had a CCTA scan recently, are scheduled for an elective PCI (percutaneous coronary intervention, a procedure to open blocked arteries), and are clinically stable. The main goal is to see the impact of the Heartflow PCI Navigator at 90 days. The study is currently collecting data.

Study design
This is an observational study that plans to include 5000 participants. It compares patient data before and after doctors start using the Heartflow PCI Navigator.
What's involved
Baseline demographic, medical history, procedural, and in-hospital outcome information will be collected after your procedure. No post-discharge follow-up data will be collected.
Compensation
Not stated in the trial record.
Follow-up
No post-discharge follow-up data will be collected.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07479433

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

Recruiting
Not specifiedAges 18+Observational
HeartFlow, Inc.
~5,000 participants
Updated 2026-03-23 on ClinicalTrials.gov
What's tested:Heartflow PCI Navigator

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Endpoint
Measured over 90 Days
Coronary Artery Disease (CAD)
1 sites across 1 states
Georgia1
  • Ziad Ali, MD, DPhil · PRINCIPAL_INVESTIGATOR · St. Francis Hospital & Heart Center Columbia University
  • Todd C. Villines, MD · PRINCIPAL_INVESTIGATOR · University of Virginia

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  • Primary Endpoint90 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.