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

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

• Heartflow PCI Navigator (diagnostic test)

Sponsor: HeartFlow, Inc. · Participants: 5,000 · Started: Mar 11, 2026

Contact the study team

• Abby Doctolero · Phone: 650-241-1221
• Sarah Mullen · Phone: 650-241-1221

Official record on ClinicalTrials.gov — NCT07479433

Locations in the U.S.

Conditions

• Coronary Artery Disease

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.