Coronary Artery DiseaseVis-Rx PMENCT04533503
Vis-Rx Post-Market Evaluation
An observational study of Coronary Artery Disease, run by Gentuity, LLC at 3 sites in United States.
Trial summary
Post-market clinical evaluation of the Gentuity High-Frequency Optical Coherence Tomography (HF-OCT) System and the Vis-Rx Micro-Imaging Catheter for use in Percutaneous Coronary Intervention (PCI) procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter
- Type of treatment
- Medical device
- How many people
- 257 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Feb 2021to 25 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients in the cardiac catheterization lab who are candidates for transluminal interventional procedures
Who may be able to join
- 18 years of age or older
- Willing and able to provide written informed consent to participate
- Transluminal interventional procedure for their coronary arteries
- General Exclusion Criteria:
- Bacteremia or sepsis
- Major coagulation system abnormalities
Show all 16Show fewer
- Severe hemodynamic instability or shock
- Acute renal failure
- Disqualified for Coronary Artery Bypass Graft (CABG) surgery
- Disqualified for PCI procedure
- Currently enrolled in another study to evaluate an investigational device or medication
- Lesion-Specific Exclusion Criteria:
- Total occlusion
- Coronary artery spasm
- Large thrombus (visible under angiography)
- Any target vessel which has undergone a bypass procedure
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Baptist Health Lexington
Lexington, Kentucky, 40503
University of South Florida
Tampa, Florida, 33606
About this study
Official title: Post-Market Clinical Evaluation of the Gentuity High-Frequency Optical Coherence Tomography Imaging System and Vis-Rx Micro-Imaging Catheter
Post-market clinical evaluation of the Gentuity High-Frequency Optical Coherence Tomography (HF-OCT) System and the Vis-Rx Micro-Imaging Catheter for use in Percutaneous Coronary Intervention (PCI) procedures.
Read the detailed description
Prospective, single-arm, unblinded, multi-center, post-market clinical evaluation assessing the imaging capabilities of the Gentuity HF-OCT System and the Vis-Rx Micro-Imaging Catheter for use in PCI procedures. Objectives are to evaluate the clinical and technical performance in the target patient population.
- Conditions
- Coronary Artery Disease
- Being tested
- HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter
- 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.
HF-OCT Imaging with the Vis-Rx Micro-Imaging CatheterDevice
Intracoronary HF-OCT imaging of the target lesion(s) during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| HF-OCT imaging | Enrolled subjects who meet lesion-specific eligibility criteria and undergo HF-OCT imaging Receives: Device: HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance
Operator evaluation of performance via Likert scale
Measured: Immediately after the procedure
Technical performance
Objective measurement of image clarity of the HF-OCT images by an independent core lab
Measured: Up to 3 months following the procedure
Secondary outcomes (1)
Complete pullbacks
Percentage of HF-OCT images with maximum clear image length
Measured: Up to 3 months following the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start22 Feb 2021
- Primary completion25 Jan 2023
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Prospective
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gentuity, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533503
- Sponsor's protocol ID
- 003175
- Acronym
- Vis-Rx PME
- Status last verified
- Mar 2025
- First submitted
- 25 Aug 2020
- Last updated
- 20 Mar 2025
- 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 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Evaluation of the Gentuity High-Frequency Optical Coherence Tomography Imaging System and Vis-Rx Micro-Imaging Catheter
- ClinicalTrials.gov ID
- NCT04533503
- Acronym / sponsor ID
- Vis-Rx PME / 003175
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Gentuity, LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 31 Aug 2020 (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.
Post-market clinical evaluation of the Gentuity High-Frequency Optical Coherence Tomography (HF-OCT) System and the Vis-Rx Micro-Imaging Catheter for use in Percutaneous Coronary Intervention (PCI) procedures.
Detailed description
Prospective, single-arm, unblinded, multi-center, post-market clinical evaluation assessing the imaging capabilities of the Gentuity HF-OCT System and the Vis-Rx Micro-Imaging Catheter for use in PCI procedures. Objectives are to evaluate the clinical and technical performance in the target patient population.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HF-OCT imaging | – | Device: HF-OCT Imaging with the Vis-Rx Micro-Imaging CatheterEnrolled subjects who meet lesion-specific eligibility criteria and undergo HF-OCT imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the cardiac catheterization lab who are candidates for transluminal interventional procedures
Key inclusion criteria (16 listed)
- 18 years of age or older
- Willing and able to provide written informed consent to participate
- Transluminal interventional procedure for their coronary arteries
- Bacteremia or sepsis
- Major coagulation system abnormalities
Key exclusion criteria (0 listed)
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 Imaging with the Vis-Rx Micro-Imaging CatheterIntracoronary HF-OCT imaging of the target lesion(s) during the procedure. | Device | HF-OCT imaging |
Primary outcome
Clinical performance
Time frame: Immediately after the procedure
Operator evaluation of performance via Likert scale
Technical performance
Time frame: Up to 3 months following the procedure
Objective measurement of image clarity of the HF-OCT images by an independent core lab
1 secondary outcome
Complete pullbacks
Time frame: Up to 3 months following the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 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 Artery Disease, run by Gentuity, LLC at 3 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 16 inclusion and 0 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: finished, 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 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance (time frame: Immediately after the procedure). The study lists 2 primary outcomes in all. 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.