Coronary Artery Disease (CAD)
Conditions
Keywords
CAD, PCI Navigator, CT-Guided PCI, PCI
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.
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_TESTHeartflow 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 typically requires significant time and effort to obtain in the cath lab.
Sponsors
HeartFlow, Inc.
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint | 90 Days | The primary endpoint will be assessed only in Group 2 and is a change in procedural plan following review of the information provided by PCI Navigator compared to procedural plan with angiographic imaging alone. The primary endpoint will be measured by calculating the percentage of patients in whom a change of plan was documented following review of the PCI Navigator tool compared to the plan documented prior to using the tool. |
Secondary
| Measure | Time frame |
|---|---|
| Changes in confidence with and without PCI Navigator (assessed in Groups 2 and 3 as two separate analyses) | 90 days for Group 2, 18 months for Group 3 |
| Change in procedural time with and without PCI Navigator | 90 days |
| Change in contrast usage with and without PCI Navigator | 90 days |
| Change in radiation usage during PCI with and without PCI Navigator | 90 days |
| Change in invasive imaging (angiographic or other) with and without PCI Navigator | 90 days |
| Change in resource utilization with and without PCI Navigator | 90 days |
Countries
United States
Contacts
CONTACTAbby Doctolero
CONTACTSarah Mullen
PRINCIPAL_INVESTIGATORZiad Ali, MD, DPhil
St. Francis Hospital & Heart Center Columbia University
PRINCIPAL_INVESTIGATORTodd C. Villines, MD
University of Virginia
Outcome results
None listed