RecruitingNCT07479433

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


Sponsor

HeartFlow, Inc.

Enrollment

5,000 participants

Start Date

Mar 11, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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

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Interventions

DIAGNOSTIC_TESTHeartflow 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.


Locations(1)

Wellstar Health System

Marietta, Georgia, United States

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NCT07479433


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