Coronary StenosisNCT05312164
Physio-Anatomy Clinical Data Collection Study
An observational study of Coronary Stenosis, run by Gentuity, LLC at 6 sites in United States.
Trial summary
This is an on-label clinical study design intended for the collection of three different types of interventional procedural data using FDA-cleared cardiac catheterization technologies and drugs, each used according to its product labeling and standard practice of medicine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Stenosis
- What is being tested?
- HF-OCT Imaging, FFR Pressure Wire and Angiography
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 6 sitesUnited States
- Study dates
- 14 Mar 2022to 31 Dec 2025
- 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
- Adult, Older adult
Study population: Patients who are candidates for PCI who already have a scheduled visit to the cardiac cath lab.
Who may be able to join
- Patients >18 years of age.
- Patients provide written informed consent.
- Clinical presentation consistent with suspected coronary disease.
- Patients who are candidates for PCI and scheduled for coronary diagnostics in the cardiac catheter lab with the intent to perform a physiological assessment for de novo lesions with stenosis, if clinically indicated.
Who cannot join
- Presence of acute ST Elevation Myocardial Infarction (STEMI) at the time of the cath lab procedure.
- Contraindication for FFR examination or administration of vasodilators.
- Bacteremia or sepsis.
- Major coagulation system abnormalities.
- Severe hemodynamic instability or shock.
- Heart Failure NYHA Class IV.
Show all 12Show fewer
- Severe valvular heart disease.
- Prior heart transplant.
- Acute renal failure based on diagnostic practice of the treating physician at time of screening.
- Patient is pregnant.
- Patient is currently enrolled in another clinical study that may impact the results of this study.
- Patient has other co-morbid condition(s) that, in the opinion of the Investigator, could limit their
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Eric A Osborn, MD, PhD
- Recruiting
The Christ Hospital
Cincinnati, Ohio, 45219
Jarrod Frizzell, MD
- Recruiting
Atlanta VA Medical Center
Decatur, Georgia, 30033
Gautam Kumar, MD
- Recruiting
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417
Alok Sharma, MD
- Recruiting
Veteran's Administration Palo Alto
Palo Alto, California, 94304
William Fearon, MD
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
Thanh Tran, 813-844-8544, tqtran@usf.edu
Hiram Bezerra, MD
About this study
This is an on-label clinical study design intended for the collection of three different types of interventional procedural data using FDA-cleared cardiac catheterization technologies and drugs, each used according to its product labeling and standard practice of medicine.
Read the detailed description
These devices and drugs are commonly used for patient evaluation during PCI procedures performed by Interventional Cardiologists. The three device technologies used in a single catheterization laboratory visit for assessment of the coronary arteries include:
- A coronary angiography imaging system to X-ray the coronary arteries for the evaluation of vessel narrowing or blocking.
- Pressure guidewire from one or more manufacturers for the measurement of coronary physiology parameters.
- Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging catheter for imaging and sizing of the stenosed coronary arteries.
- Conditions
- Coronary Stenosis
- Being tested
- HF-OCT Imaging, FFR Pressure Wire, Angiography
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HF-OCT ImagingDevice
Subjects undergo HF-OCT imaging of stenosed coronary arteries
FFR Pressure WireDevice
Subjects undergo FFR physiology assessment of stenosed coronary arteries
AngiographyDevice
Subjects undergo angiography imaging of stenosed coronary arteries
| Study group | Role | What they receive |
|---|---|---|
| Candidates for PCI | Patients undergoing diagnostic cardiac catheterization/PCI. Receives: Device: HF-OCT Imaging; Device: FFR Pressure Wire; Device: Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of angiography images, HF-OCT images, and FFR pressure wire data
There are no efficacy or safety outcomes in this study. This study is a simple data collection study to help the sponsor develop next-generation HF-OCT software. Pressure wire data will be paired with HF-OCT images and angiography images for analysis to determine if the HF-OCT imaging technology can predict FFR physiology information from the OCT pullback.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start14 Mar 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary StenosisStudies 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
- Case only
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gentuity, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312164
- Sponsor's protocol ID
- 003785
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2022
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physio-Anatomy Clinical Data Collection Study
- ClinicalTrials.gov ID
- NCT05312164
- Acronym / sponsor ID
- 003785
- Conditions
- Coronary Stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Gentuity, LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Apr 2022 (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.
This is an on-label clinical study design intended for the collection of three different types of interventional procedural data using FDA-cleared cardiac catheterization technologies and drugs, each used according to its product labeling and standard practice of medicine.
Detailed description
These devices and drugs are commonly used for patient evaluation during PCI procedures performed by Interventional Cardiologists. The three device technologies used in a single catheterization laboratory visit for assessment of the coronary arteries include:
- A coronary angiography imaging system to X-ray the coronary arteries for the evaluation of vessel narrowing or blocking.
- Pressure guidewire from one or more manufacturers for the measurement of coronary physiology parameters.
- Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging catheter for imaging and sizing of the stenosed coronary arteries.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Candidates for PCI | – | Device: HF-OCT Imaging, Device: FFR Pressure Wire, Device: AngiographyPatients undergoing diagnostic cardiac catheterization/PCI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who are candidates for PCI who already have a scheduled visit to the cardiac cath lab.
Key inclusion criteria (4 listed)
- Patients >18 years of age.
- Patients provide written informed consent.
- Clinical presentation consistent with suspected coronary disease.
- Patients who are candidates for PCI and scheduled for coronary diagnostics in the cardiac catheter lab with the intent to perform a physiological assessment for de novo lesions with stenosis, if clinically indicated.
Key exclusion criteria (12 listed)
- Presence of acute ST Elevation Myocardial Infarction (STEMI) at the time of the cath lab procedure.
- Contraindication for FFR examination or administration of vasodilators.
- Bacteremia or sepsis.
- Major coagulation system abnormalities.
- Severe hemodynamic instability or shock.
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 |
|---|---|---|
| HF-OCT ImagingSubjects undergo HF-OCT imaging of stenosed coronary arteries | Device | Candidates for PCI |
| FFR Pressure WireSubjects undergo FFR physiology assessment of stenosed coronary arteries | Device | Candidates for PCI |
| AngiographySubjects undergo angiography imaging of stenosed coronary arteries | Device | Candidates for PCI |
Primary outcome
Collection of angiography images, HF-OCT images, and FFR pressure wire data
Time frame: 2 years
There are no efficacy or safety outcomes in this study. This study is a simple data collection study to help the sponsor develop next-generation HF-OCT software. Pressure wire data will be paired with HF-OCT images and angiography images for analysis to determine if the HF-OCT imaging technology can predict FFR physiology information from the OCT pullback.
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 20 Mar 2025.
Related trials for Coronary Stenosis
RecruitingObservational study
Defining the Brain Phenotype of Children With Williams Syndrome
Williams Syndrome, Duplication
RecruitingObservational study
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
Severe Aortic Valve Stenosis, Valvular Heart Disease
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Active, not recruiting
Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
Coronary Artery Disease, Coronary Artery Stenoses
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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Stenosis, run by Gentuity, LLC at 6 sites 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 4 inclusion and 12 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 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 Arjun Bhat, MD, MBA (978-202-4108, abhat@gentuity.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of angiography images, HF-OCT images, and FFR pressure wire data (time frame: 2 years). 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 20 Mar 2025.