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NCT04533503: Vis-Rx PME
Vis-Rx Post-Market Evaluation
trial testing HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter in Coronary Artery Disease in 257 participants. Completed in 25 January 2023.
25 January 2023
Quick facts
| Lead sponsor | Gentuity, LLC |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 257 |
| Start date | 22 February 2021 |
| Primary completion | 25 January 2023 |
| Estimated completion | 25 January 2023 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
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):
-
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
Verify or expand the search:
- PubMed search for NCT04533503
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Gentuity, LLC trials
Trials by the same sponsor.
- NCT06685783 — Vis-Rx Prime Micro-Imaging Catheter Study · completed
- NCT05312164 — Physio-Anatomy Clinical Data Collection Study · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04533503 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Gentuity, LLC
- Last refreshed: 20 March 2025
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