The NAVIGATE-PCI Registry: A New Approach to VIew CT-derived Guidance Ahead of Stenting To Plan Efficient PCI
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Georgia
Wellstar Health System
RECRUITING
Marietta
Contact Information
Primary
Abby Doctolero
adoctolero@heartflow.com
650-241-1221
Backup
Sarah Mullen
smullen@heartflow.com
650-241-1221
Time Frame
Start Date: 2026-03-11
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 5000
Treatments
Group 1: No PCI Navigator
This group includes consecutive patients who have undergone a CCTA a maximum of 90 days prior to an elective PCI at the study site; the CCTA is not required to have been used in procedural planning but must have acceptable image quality according to Heartflow's image quality requirements
Group 2: Intraprocedural PCI Planning
This group includes patients who had a CCTA and a referral for elective PCI following the introduction of the PCI Navigator at the study site. The PCI should be performed no more than 90 days following the CCTA. Interventionalists will document their procedural plan after initial invasive angiographic images are reviewed but before reviewing the information provided by the PCI Navigator, and then again after reviewing the information provided by the PCI Navigator. Usage of invasive imaging following review of the PCI Navigator is at the discretion of the interventionalist.
Group 3: Preprocedural Planning
This group includes patients who had a CCTA and a referral for elective PCI following the introduction of the PCI Navigator at the study site. The PCI should be performed no more than 90 days following the CCTA. Interventionalists will document their procedural plan before reviewing the information provided by the PCI Navigator and prior to initial invasive angiographic imaging, and then again after reviewing the information provided by the PCI Navigator. Usage of angiographic and other invasive imaging following review of the PCI Navigator is at the discretion of the interventionalist.
Related Therapeutic Areas
Sponsors
Leads: HeartFlow, Inc.