Recruiting

Observational Study

Sponsor:

HeartFlow, Inc.

Code:

NCT07479433

Conditions

Coronary Artery Disease (CAD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Heartflow PCI Navigator

Study Details

Brief 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)

Study ID

NCT07479433

Start date

Mar 11, 2026

Status verified date

Mar, 2026

Completion date

Dec 31, 2032

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Primary Endpoint [ Time Frame: 90 Days ]

Central Contacts and Locations

Central contacts

Abby Doctolero

650-241-1221adoctolero@heartflow.com

Sarah Mullen

650-241-1221smullen@heartflow.com

Locations

Wellstar Health System

Recruiting

Marietta, Georgia, United States, 30060

Contacts

Frank Corrigan, MD

470-793-4034Frank.Corrigan@wellstar.org

More Information

Sponsor

HeartFlow, Inc.

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Keywords

  • CAD
  • PCI Navigator
  • CT-Guided PCI
  • PCI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by HeartFlow, Inc. on 2026-03-23.