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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease (CAD)
• Intervention / Treatment: Diagnostic test: Heartflow 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.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Abby Doctolero; Phone Number: 650-241-1221; Email: adoctolero@heartflow.com
• Study Contact Backup: Name: Sarah Mullen; Phone Number: 650-241-1221; Email: smullen@heartflow.com

Study Locations

• United States
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Recruiting
      • Wellstar Health System
      • Contact: Frank Corrigan, MD; Phone Number: 470-793-4034; Email: Frank.Corrigan@wellstar.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Deidentified data will be collected for all patients included in the registry who had a CCTA with acceptable image quality prior to elective PCI and are included by the site in the registry. Patients with prior CABG or patients with intervention planned in a previously stented vessel territory are excluded.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1: No PCI Navigator; This group includes consecutive patients who have undergone a CCTA a maximum of 90 days prior to an elective PCI at the study site; the CCTA is not required to have been used in procedural planning but must have acceptable image quality according to Heartflow's image quality requirements
Group 2: Intraprocedural PCI Planning; This group includes patients who had a CCTA and a referral for elective PCI following the introduction of the PCI Navigator at the study site. The PCI should be performed no more than 90 days following the CCTA. Interventionalists will document their procedural plan after initial invasive angiographic images are reviewed but before reviewing the information provided by the PCI Navigator, and then again after reviewing the information provided by the PCI Navigator. Usage of invasive imaging following review of the PCI Navigator is at the discretion of the interventionalist.	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.
Group 3: Preprocedural Planning; This group includes patients who had a CCTA and a referral for elective PCI following the introduction of the PCI Navigator at the study site. The PCI should be performed no more than 90 days following the CCTA. Interventionalists will document their procedural plan before reviewing the information provided by the PCI Navigator and prior to initial invasive angiographic imaging, and then again after reviewing the information provided by the PCI Navigator. Usage of angiographic and other invasive imaging following review of the PCI Navigator is at the discretion of the interventionalist.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoint	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.	90 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in confidence with and without PCI Navigator (assessed in Groups 2 and 3 as two separate analyses)	90 days for Group 2, 18 months for Group 3
Change in procedural time with and without PCI Navigator	90 days
Change in contrast usage with and without PCI Navigator	90 days
Change in radiation usage during PCI with and without PCI Navigator	90 days
Change in invasive imaging (angiographic or other) with and without PCI Navigator	90 days
Change in resource utilization with and without PCI Navigator	90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory and Safety Endpoint	Perform all endpoint analyses with a comparison of male vs. female as an added variable	5 years
Exploratory and Safety Endpoint	Procedural complications and in-hospital outcomes	5 years

Collaborators and Investigators

• Sponsor: HeartFlow, Inc.
• Investigators: Principal Investigator: Ziad Ali, MD, DPhil, St. Francis Hospital & Heart Center Columbia University; Principal Investigator: Todd C. Villines, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: PCI; CAD; PCI Navigator; CT-Guided PCI
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: CP-911-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No