Trials / Completed
CompletedNCT03715452
DyeVert™ Plus Contrast Reduction System Multicenter Observational Study
Minimizing Radiographic Contrast Administration During Coronary Angiography Using a Novel Contrast Reduction System: A Multicenter Observational Study of the DyeVert™ Plus Contrast Reduction System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 114 (actual)
- Sponsor
- Osprey Medical, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, single arm, multi-center, observational clinical study of the DyeVert Plus System. The DyeVert Plus System is an FDA-cleared device designed to reduce contrast media volume delivered during angiography and permit real-time contrast media volume monitoring.
Detailed description
The purpose of this observational study is to evaluate the amount of contrast media saved using DyeVert Plus in coronary angiographic and/or interventional procedures performed with manual injection and evaluate the impact of predetermined thresholds and real-time monitoring.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | DyeVert Plus Contrast Reduction System | The DyeVert Plus System interfaces with standard manifold systems to provide real-time contrast monitoring and reduce the amount of contrast used in catheterization procedures while maintaining fluoroscopic image quality. System components include a disposable, single-use, sterile DyeVert Plus Disposable Kit that contains a Smart Syringe and DyeVert Plus Module, which is connected to a standard manifold and provides fluid pathway resistance modulation via a dedicated diversion valve. The diversion valve self-adjusts to the manual injection pressure to divert some of the contrast media into the reservoir chamber within the module. This diverted volume of contrast media does not enter the patient. |
Timeline
- Start date
- 2017-07-01
- Primary completion
- 2018-01-31
- Completion
- 2018-03-30
- First posted
- 2018-10-23
- Last updated
- 2020-10-19
- Results posted
- 2020-10-19
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03715452. Inclusion in this directory is not an endorsement.