Coronary Artery Disease (CAD)NAVIGATE-PCINCT07479433
The NAVIGATE-PCI Registry: A New Approach to VIew CT-derived Guidance Ahead of Stenting To Plan Efficient PCI
An observational study of Coronary Artery Disease (CAD), run by HeartFlow, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD)
- What is being tested?
- Heartflow PCI Navigator
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2026to 31 Dec 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Deidentified data will be collected for all patients included in the registry who had a CCTA with acceptable image quality prior to elective PCI and are included by the site in the registry. Patients with prior CABG or patients with intervention planned in a previously stented vessel territory are excluded.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wellstar Health System
Marietta, Georgia, 30060
Frank Corrigan, MD, 470-793-4034, Frank.Corrigan@wellstar.org
About this study
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.
Read the 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.
- Conditions
- Coronary Artery Disease (CAD)
- Being tested
- Heartflow PCI Navigator
- Keywords
- CAD, PCI Navigator, CT-Guided PCI, PCI
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heartflow PCI NavigatorDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Heartflow PCI Navigator | |
| 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. Receives: Diagnostic Test: Heartflow PCI Navigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
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.
Measured: 90 Days
Secondary outcomes (6)
Changes in confidence with and without PCI Navigator (assessed in Groups 2 and 3 as two separate analyses)
Measured: 90 days for Group 2, 18 months for Group 3
Change in procedural time with and without PCI Navigator
Measured: 90 days
Change in contrast usage with and without PCI Navigator
Measured: 90 days
Change in radiation usage during PCI with and without PCI Navigator
Measured: 90 days
Change in invasive imaging (angiographic or other) with and without PCI Navigator
Measured: 90 days
Change in resource utilization with and without PCI Navigator
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start11 Mar 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- HeartFlow, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ziad Ali, MD, DPhil, Principal investigator, St. Francis Hospital & Heart Center Columbia UniversityTodd C. Villines, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479433
- Sponsor's protocol ID
- CP-911-001
- Acronym
- NAVIGATE-PCI
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The NAVIGATE-PCI Registry: A New Approach to VIew CT-derived Guidance Ahead of Stenting To Plan Efficient PCI
- ClinicalTrials.gov ID
- NCT07479433
- Acronym / sponsor ID
- NAVIGATE-PCI / CP-911-001
- Conditions
- Coronary Artery Disease (CAD)
- Keywords
- CAD, PCI Navigator, CT-Guided PCI, PCI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- HeartFlow, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Diagnostic Test: Heartflow PCI NavigatorThis 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 | – | Diagnostic Test: Heartflow PCI NavigatorThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Deidentified data will be collected for all patients included in the registry who had a CCTA with acceptable image quality prior to elective PCI and are included by the site in the registry. Patients with prior CABG or patients with intervention planned in a previously stented vessel territory are excluded.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heartflow PCI NavigatorHeartflow 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. | Diagnostic test | Group 2: Intraprocedural PCI Planning, Group 3: Preprocedural Planning |
Primary outcome
Primary Endpoint
Time frame: 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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ziad Ali, MD, DPhil principal investigator
St. Francis Hospital & Heart Center Columbia University
Todd C. Villines, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease (CAD), run by HeartFlow, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abby Doctolero (650-241-1221, adoctolero@heartflow.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: 90 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.