Trials / Completed
CompletedNCT04533503
Vis-Rx Post-Market Evaluation
Post-Market Clinical Evaluation of the Gentuity High-Frequency Optical Coherence Tomography Imaging System and Vis-Rx Micro-Imaging Catheter
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 257 (actual)
- Sponsor
- Gentuity, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter | Intracoronary HF-OCT imaging of the target lesion(s) during the procedure. |
Timeline
- Start date
- 2021-02-22
- Primary completion
- 2023-01-25
- Completion
- 2023-01-25
- First posted
- 2020-08-31
- Last updated
- 2025-03-20
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04533503. Inclusion in this directory is not an endorsement.