The NAVIGATE-PCI Registry: A New Approach to VIew CT-derived Guidance Ahead of Stenting To Plan Efficient PCI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Heartflow PCI Navigator.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease (CAD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
Heartflow's NAVIGATE-PCI Registry is a post-market, multi-center, data collection registry assessing confidence in procedure planning, time of procedure, contrast usage during procedure, radiation usage during procedure, invasive imaging (angiographic or other), and resource utilization. Sites will provide retrospective data from patients receiving an elective PCI prior to the deployment of PCI Navigator vs. after deployment and operator training on how to use the information provided by PCI Navigator. Baseline demographic, medical history, procedural, and in-hospital outcome information will be collected following the procedure. No post discharge follow-up data will be collected.
Interventions
- Diagnostic test Heartflow 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 t
Primary outcome measures
- Primary Endpoint [Time frame: 90 Days]
Secondary outcome measures (6)
- Changes in confidence with and without PCI Navigator (assessed in Groups 2 and 3 as two separate analyses) [Time frame: 90 days for Group 2, 18 months for Group 3]
- Change in procedural time with and without PCI Navigator [Time frame: 90 days]
- Change in contrast usage with and without PCI Navigator [Time frame: 90 days]
- Change in radiation usage during PCI with and without PCI Navigator [Time frame: 90 days]
- Change in invasive imaging (angiographic or other) with and without PCI Navigator [Time frame: 90 days]
- Change in resource utilization with and without PCI Navigator [Time frame: 90 days]
Eligibility criteria
Inclusion Criteria (all must be present):
- 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 Criteria (all must be present):
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Wellstar Health System — Marietta
Identifiers
NCT: NCT07479433 · CP-911-001