NAVIGATE-PCI: Using CT images to guide planning for elective stenting.
The NAVIGATE-PCI Registry: A New Approach to VIew CT-derived Guidance Ahead of Stenting To Plan Efficient PCI
This registry will try CT-based PCI Navigator guidance to see if it helps cardiologists plan elective stenting for patients with stable coronary artery disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | HeartFlow, Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Marietta, Georgia) |
| Trial ID | NCT07479433 on ClinicalTrials.gov |
What this trial studies
This post-market, multi-center registry collects retrospective data from elective PCI procedures performed before and after sites adopt HeartFlow's PCI Navigator and complete operator training. Sites submit baseline demographics, medical history, procedural details, and in-hospital outcomes, with specific metrics including operator confidence, procedure time, contrast and radiation use, invasive imaging, and resource utilization. Eligible patients must have a diagnostic-quality coronary CT angiogram within 90 days and be clinically stable without suspected acute coronary syndrome; patients with prior CABG, planned intervention in previously stented vessels, ED presentation, or ongoing ACS are excluded. No post-discharge follow-up is collected and the registry observationally compares outcomes pre- and post-adoption rather than randomizing patients.
Who should consider this trial
Good fit: Clinically stable adults with coronary artery disease referred for elective PCI who had a diagnostic-quality coronary CT angiogram within 90 days and meet the registry's exclusion criteria.
Not a fit: Patients with acute chest pain or suspected ACS, those presenting via the emergency department, those with previous CABG, or those needing intervention in a previously stented vessel are excluded and would not be represented by this registry.
Why it matters
Potential benefit: If successful, it could help operators plan PCI more efficiently and safely, potentially reducing procedure time, contrast load, and radiation exposure for patients.
How similar studies have performed: Other CT-based planning tools and HeartFlow's prior CT-derived physiology methods have shown promising results for lesion assessment and planning, but using CT-guided navigation specifically to change PCI workflow is relatively new and has limited large-scale outcome data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Marietta, Georgia
- Wellstar Health System — Marietta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Ziad Ali, MD, DPhil — St. Francis Hospital & Heart Center Columbia University
- Study coordinator: Abby Doctolero
- Email: adoctolero@heartflow.com
- Phone: 650-241-1221
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.