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NCT04533503: Vis-Rx PME

Vis-Rx Post-Market Evaluation

Completed Last updated 20 March 2025
What this trial tests

trial testing HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter in Coronary Artery Disease in 257 participants. Completed in 25 January 2023.

Timeline
22 February 2021
Primary endpoint
25 January 2023
25 January 2023

Quick facts

Lead sponsorGentuity, LLC
StatusCompleted
Study typeOBSERVATIONAL
Enrollment257
Start date22 February 2021
Primary completion25 January 2023
Estimated completion25 January 2023
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Gentuity, LLC

Who can join

18 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Efficacy and Safety of High-Frequency Optical Coherence Tomography (HF-OCT) for Coronary Imaging: A Multicenter Study.
    Quimby DL, Rothstein ES, Richmond HCT, Bassily E, et al · · 2025 · cited 1× · PMID 40231063 · DOI 10.1016/j.jscai.2025.102577

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Other recruiting trials for Coronary Artery Disease

Currently open trials in the same condition.

Other Gentuity, LLC trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04533503.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing