Vis-Rx Post-Market Evaluation
Vis-Rx PME
Post-Market Clinical Evaluation of the Gentuity High-Frequency Optical Coherence Tomography Imaging System and Vis-Rx Micro-Imaging Catheter
1 other identifier
observational
257
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2021
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2020
CompletedFirst Posted
Study publicly available on registry
August 31, 2020
CompletedStudy Start
First participant enrolled
February 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2023
CompletedMarch 20, 2025
March 1, 2025
1.9 years
August 25, 2020
March 19, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Clinical performance
Operator evaluation of performance via Likert scale
Immediately after the procedure
Technical performance
Objective measurement of image clarity of the HF-OCT images by an independent core lab
Up to 3 months following the procedure
Secondary Outcomes (1)
Complete pullbacks
Up to 3 months following the procedure
Study Arms (1)
HF-OCT imaging
Enrolled subjects who meet lesion-specific eligibility criteria and undergo HF-OCT imaging
Interventions
Intracoronary HF-OCT imaging of the target lesion(s) during the procedure.
Eligibility Criteria
Patients in the cardiac catheterization lab who are candidates for transluminal interventional procedures
You may qualify if:
- years of age or older
- Willing and able to provide written informed consent to participate
- Transluminal interventional procedure for their coronary arteries
You may not qualify if:
- Bacteremia or sepsis
- Major coagulation system abnormalities
- 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
- Total occlusion
- Coronary artery spasm
- Large thrombus (visible under angiography)
- Any target vessel which has undergone a bypass procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gentuity, LLClead
Study Sites (3)
University of South Florida
Tampa, Florida, 33606, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2020
First Posted
August 31, 2020
Study Start
February 22, 2021
Primary Completion
January 25, 2023
Study Completion
January 25, 2023
Last Updated
March 20, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share