← Back to Clinical Trials
Recruiting NCT07479433

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

Trial Parameters

Condition Coronary Artery Disease (CAD)
Sponsor HeartFlow, Inc.
Study Type OBSERVATIONAL
Phase N/A
Enrollment 5,000
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2026-03-11
Completion 2026-09-30
Interventions
Heartflow PCI Navigator

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.

Eligibility Criteria

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

Related Trials