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

Part of paid clinical trials in Marietta, Georgia.

Sponsor
HeartFlow, Inc.
Study ID
NCT07479433
Status
Recruiting
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Conditions

  • Coronary Artery Disease (CAD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Mar 11, 2026
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Dec 31, 2032

Study Design

Enrollment
5,000 participants (estimated)

Arms

  • Arm: 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
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Primary Endpoint [ Time Frame: 90 Days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wellstar Health SystemMariettaGeorgia30060
Frank Corrigan, MD
[email protected]
470-793-4034

Find similar trials in Marietta, GA

By research site
Wellstar Health System· Marietta, GA

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