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NCT Number: NCT07479433

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wellstar Health System

Marietta, Georgia, 30060, United States

Location status: Recruiting

Location contact

Frank Corrigan, MD

CONTACT

[email protected]

470-793-4034

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(all must be present):

  • 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

Exclusion criteria

(all must be present):

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Primary Endpoint

    Time frame: 90 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.

Secondary outcomes

  1. Changes in confidence with and without PCI Navigator (assessed in Groups 2 and 3 as two separate analyses)

    Time frame: 90 days for Group 2, 18 months for Group 3

  2. Change in procedural time with and without PCI Navigator

    Time frame: 90 days

  3. Change in contrast usage with and without PCI Navigator

    Time frame: 90 days

  4. Change in radiation usage during PCI with and without PCI Navigator

    Time frame: 90 days

  5. Change in invasive imaging (angiographic or other) with and without PCI Navigator

    Time frame: 90 days

  6. Change in resource utilization with and without PCI Navigator

    Time frame: 90 days

Other outcomes

  1. Exploratory and Safety Endpoint

    Time frame: 5 years

    Perform all endpoint analyses with a comparison of male vs. female as an added variable

  2. Exploratory and Safety Endpoint

    Time frame: 5 years

    Procedural complications and in-hospital outcomes

Study contacts

Contact information is provided by the study sponsor or research team.

Abby Doctolero

CONTACT

[email protected]

650-241-1221

Sarah Mullen

CONTACT

[email protected]

650-241-1221

Sponsors and collaborators

Lead sponsor

HeartFlow, Inc.

Industry

Registry information

Acronym: NAVIGATE-PCI

Important dates

Study start
2026
Primary completion
2026
Study completion
2032
First posted
Mar 18, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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