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

NCT07479433 | Recruiting FDA Device

• 1 other identifier: CP-911-001
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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)

Keywords

CAD; PCI Navigator; CT-Guided PCI; PCI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Other Outcomes (2)

• Exploratory and Safety Endpoint

  5 years

• Exploratory and Safety Endpoint

  5 years

Study Arms (3)

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

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

Interventions

Heartflow PCI Navigator DIAGNOSTIC_TEST

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 2: Intraprocedural PCI Planning; Group 3: Preprocedural Planning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• CCTA completed ≤90 days prior to elective PCI with acceptable image quality according to Heartflow's image quality requirements
• Referred for elective PCI
• Clinically stable without symptoms suggestive of acute coronary syndrome (ACS) at the time of the intervention

You may not qualify if:

• ED presentation (at the time of the referral for PCI)
• Previous coronary artery bypass graft (CABG)
• Planned intervention in a previously stented vessel territory
• Acute chest pain (in patients who have not been ruled out for ACS)
• Participating in a conflicting study being undertaken during the PCI

Sponsors & Collaborators

• HeartFlow, Inc.: lead

Study Sites (1)

Wellstar Health System

Marietta, Georgia, 30060, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ziad Ali, MD, DPhil

  St. Francis Hospital & Heart Center Columbia University

  PRINCIPAL INVESTIGATOR

• Todd C. Villines, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abby Doctolero

CONTACT

650-241-1221; adoctolero@heartflow.com

Sarah Mullen

CONTACT

650-241-1221; smullen@heartflow.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 18, 2026
• Study Start: March 11, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2032
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)