Coronary Artery DiseaseNCT06685783
Vis-Rx Prime Micro-Imaging Catheter Study
An observational study of Coronary Artery Disease, run by Gentuity, LLC at 3 sites in United States.
Trial summary
To study the performance of the Gentuity® HF-OCT (High Frequency Optical Coherence Tomography) Imaging System and Vis-Rx Prime® Micro-Imaging Catheter when used to obtain images of coronary arteries in patients who are undergoing cardiac catheterization and are candidates for interventional procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 34 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Dec 2024to 1 May 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 PCI
Who may be able to join
- Patients 18 years of age or older
- Patients willing and able to provide written informed consent to participate in evaluation
- Patients who are candidates for transluminal interventional procedures for their coronary arteries (also known as PCI)
Who cannot join
- Bacteremia or sepsis
- Major coagulation system abnormalities
- Severe hemodynamic instability or shock
- Acute renal failure
- Disqualified for Coronary Artery Bypass Graft surgery
- Disqualified for Percutaneous Coronary Intervention
Show all 12Show fewer
- Patients currently enrolled in another study to evaluate an investigational device or medication
- Any target vessel which has undergone a bypass procedure
- The lesion-specific exclusion criteria assessed from angiography are:
- Total occlusion
- Coronary artery spasm
- Large thrombus (as visible under angiography)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Lindner Research Center at The Christ Hospital
Cincinnati, Ohio, 45219
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
St. Francis Hospital and Heart Center
Roslyn, New York, 11576
About this study
Official title: Vis-Rx Prime Micro-Imaging Catheter Clinical Evaluation Study
To study the performance of the Gentuity® HF-OCT (High Frequency Optical Coherence Tomography) Imaging System and Vis-Rx Prime® Micro-Imaging Catheter when used to obtain images of coronary arteries in patients who are undergoing cardiac catheterization and are candidates for interventional procedures. The study will evaluate ease of catheter use by physicians using the catheters, image quality and overall performance. The patient's involvement in the study ends when the cardiac catheterization/interventional procedure is completed.
Read the detailed description
This is a single arm, unblinded, multi-center, clinical evaluation that will be performed at 3 to 5 investigational sites in the United States with subjects who undergo HF-OCT imaging as part of their cardiac catheterization procedure. This study will evaluate a range of device operators (interventional cardiologists) as well as patients and vessels consistent with the product labeling. The operator evaluation will be determined post use of the device using a Likert Grading Scale. Clear Image Length of the acquired HF-OCT image will be measured by an independent core lab. Safety will be monitored through the interventional procedure and Adverse Events that are potentially related to either the device or the procedure will be recorded, evaluated and analyzed.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Performance
Clear Image Length of the acquired HF-OCT image during each pullback during a percutaneous coronary intervention procedure
Measured: During percutaneous interventional procedure, up to 2 hours
Secondary outcomes (1)
Clinical Performance Endpoint
Clinical performance of the Gentuity HF-OCT Imaging System with the Vis-Rx Prime Micro-Imaging Catheter in a real-world setting as determined by the clinical operator using a Likert Grading Scale (1-5 scale; 1=unacceptable, 5= excellent) for each of the 4 measures [Catheter preparation, Catheter deliverability, Image Quality, Overall performance].
Measured: During percutaneous interventional procedure, up to 2 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start11 Dec 2024
- Primary completion30 Apr 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 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
- NCT06685783
- Sponsor's protocol ID
- MISC-074
- Status last verified
- Apr 2026
- First submitted
- 11 Nov 2024
- Last updated
- 17 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Swanson EA, Fujimoto JG. The ecosystem that powered the translation of OCT from fundamental research to clinical and commercial impact [Invited]. Biomed Opt Express. 2017 Feb 21;8(3):1638-1664. doi: 10.1364/BOE.8.001638. eCollection 2017 Mar 1.
PubMed 28663854van der Sijde JN, Karanasos A, van Ditzhuijzen NS, Okamura T, van Geuns RJ, Valgimigli M, Ligthart JM, Witberg KT, Wemelsfelder S, Fam JM, Zhang B, Diletti R, de Jaegere PP, van Mieghem NM, van Soest G, Zijlstra F, van Domburg RT, Regar E. Safety of optical coherence tomography in daily practice: a comparison with intravascular ultrasound. Eur Heart J Cardiovasc Imaging. 2017 Apr 1;18(4):467-474. doi: 10.1093/ehjci/jew037.
PubMed 26992420D'Ascenzo F, Iannaccone M, Saint-Hilary G, Bertaina M, Schulz-Schupke S, Wahn Lee C, Chieffo A, Helft G, Gili S, Barbero U, Biondi Zoccai G, Moretti C, Ugo F, D'Amico M, Garbo R, Stone G, Rettegno S, Omede P, Conrotto F, Templin C, Colombo A, Park SJ, Kastrati A, Hildick-Smith D, Gasparini M, Gaita F. Impact of design of coronary stents and length of dual antiplatelet therapies on ischaemic and bleeding events: a network meta-analysis of 64 randomized controlled trials and 102 735 patients. Eur Heart J. 2017 Nov 7;38(42):3160-3172. doi: 10.1093/eurheartj/ehx437.
PubMed 29020300Dilmanian H, Aronow WS, Mundia M, Pucillo AL, Weiss MB, Kalapatapu K, Monsen CE. The average stent length is longer and the average stent diameter is shorter in patients with drug-eluting stents versus bare-metal stents during percutaneous coronary intervention. Am J Ther. 2007 May-Jun;14(3):277-9. doi: 10.1097/MJT.0b013e3180653377.
PubMed 17515704Al-Sunduqchi, M. S. Determining the Appropriate Sample Size for Inferences Based on the Wilcoxon Statistics. (University of Wyoming. Department of Statistics, 1990).
Yoon JH, Di Vito L, Moses JW, Fearon WF, Yeung AC, Zhang S, Bezerra HG, Costa MA, Jang IK. Feasibility and safety of the second-generation, frequency domain optical coherence tomography (FD-OCT): a multicenter study. J Invasive Cardiol. 2012 May;24(5):206-9.
PubMed 22562913
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vis-Rx Prime Micro-Imaging Catheter Clinical Evaluation Study
- ClinicalTrials.gov ID
- NCT06685783
- Acronym / sponsor ID
- MISC-074
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Gentuity, LLCIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 12 Nov 2024 (actual)
- Results
- Posted 17 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the performance of the Gentuity® HF-OCT (High Frequency Optical Coherence Tomography) Imaging System and Vis-Rx Prime® Micro-Imaging Catheter when used to obtain images of coronary arteries in patients who are undergoing cardiac catheterization and are candidates for interventional procedures. The study will evaluate ease of catheter use by physicians using the catheters, image quality and overall performance. The patient's involvement in the study ends when the cardiac catheterization/interventional procedure is completed.
Detailed description
This is a single arm, unblinded, multi-center, clinical evaluation that will be performed at 3 to 5 investigational sites in the United States with subjects who undergo HF-OCT imaging as part of their cardiac catheterization procedure. This study will evaluate a range of device operators (interventional cardiologists) as well as patients and vessels consistent with the product labeling. The operator evaluation will be determined post use of the device using a Likert Grading Scale. Clear Image Length of the acquired HF-OCT image will be measured by an independent core lab. Safety will be monitored through the interventional procedure and Adverse Events that are potentially related to either the device or the procedure will be recorded, evaluated and analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
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 PCI
Key inclusion criteria (3 listed)
- Patients 18 years of age or older
- Patients willing and able to provide written informed consent to participate in evaluation
- Patients who are candidates for transluminal interventional procedures for their coronary arteries (also known as PCI)
Key exclusion criteria (12 listed)
- Bacteremia or sepsis
- Major coagulation system abnormalities
- Severe hemodynamic instability or shock
- Acute renal failure
- Disqualified for Coronary Artery Bypass Graft surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Technical Performance
Time frame: During percutaneous interventional procedure, up to 2 hours
Clear Image Length of the acquired HF-OCT image during each pullback during a percutaneous coronary intervention procedure
1 secondary outcome
Clinical Performance Endpoint
Time frame: During percutaneous interventional procedure, up to 2 hours.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28663854Swanson EA, Fujimoto JG. The ecosystem that powered the translation of OCT from fundamental research to clinical and commercial impact [Invited]. Biomed Opt Express. 2017 Feb 21;8(3):1638-1664. doi: 10.1364/BOE.8.001638. eCollection 2017 Mar 1.
- Results publication: PubMed 26992420van der Sijde JN, Karanasos A, van Ditzhuijzen NS, Okamura T, van Geuns RJ, Valgimigli M, Ligthart JM, Witberg KT, Wemelsfelder S, Fam JM, Zhang B, Diletti R, de Jaegere PP, van Mieghem NM, van Soest G, Zijlstra F, van Domburg RT, Regar E. Safety of optical coherence tomography in daily practice: a comparison with intravascular ultrasound. Eur Heart J Cardiovasc Imaging. 2017 Apr 1;18(4):467-474. doi: 10.1093/ehjci/jew037.
- Results publication: PubMed 29020300D'Ascenzo F, Iannaccone M, Saint-Hilary G, Bertaina M, Schulz-Schupke S, Wahn Lee C, Chieffo A, Helft G, Gili S, Barbero U, Biondi Zoccai G, Moretti C, Ugo F, D'Amico M, Garbo R, Stone G, Rettegno S, Omede P, Conrotto F, Templin C, Colombo A, Park SJ, Kastrati A, Hildick-Smith D, Gasparini M, Gaita F. Impact of design of coronary stents and length of dual antiplatelet therapies on ischaemic and bleeding events: a network meta-analysis of 64 randomized controlled trials and 102 735 patients. Eur Heart J. 2017 Nov 7;38(42):3160-3172. doi: 10.1093/eurheartj/ehx437.
- Results publication: PubMed 17515704Dilmanian H, Aronow WS, Mundia M, Pucillo AL, Weiss MB, Kalapatapu K, Monsen CE. The average stent length is longer and the average stent diameter is shorter in patients with drug-eluting stents versus bare-metal stents during percutaneous coronary intervention. Am J Ther. 2007 May-Jun;14(3):277-9. doi: 10.1097/MJT.0b013e3180653377.
- Results publicationAl-Sunduqchi, M. S. Determining the Appropriate Sample Size for Inferences Based on the Wilcoxon Statistics. (University of Wyoming. Department of Statistics, 1990).
- Results publication: PubMed 22562913Yoon JH, Di Vito L, Moses JW, Fearon WF, Yeung AC, Zhang S, Bezerra HG, Costa MA, Jang IK. Feasibility and safety of the second-generation, frequency domain optical coherence tomography (FD-OCT): a multicenter study. J Invasive Cardiol. 2012 May;24(5):206-9.
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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 3 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: finished, as of the sponsor's last update on 17 Apr 2026. 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?
Yes. Results are posted in the registry (first posted 17 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Technical Performance (time frame: During percutaneous interventional procedure, up to 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06685783, which also lists 6 linked publications.
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 17 Apr 2026.