NAVIGATE-PCI: Using CT images to guide planning for elective stenting.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.