Not provided
Not provided
Not provided
Not provided
Not provided
Competing clinical trial priorities
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Osprey Medical, Inc | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The is an observational, prospective study to evaluate the effect of the DyeVert System on contrast volume administration in patients undergoing clinically-indicated chronic total occlusion (CTO) percutaneous coronary intervention (PCI)
The DyeVert System is a disposable, FDA-approved device that interfaces with standard manifold systems to reduce the amount of contrast used in catheterization procedures, while maintaining fluoroscopic image opacity.
No study has assessed use of the system in CTO PCI. It would be expected that savings in CTO procedures may be less than non-CTO procedures due to catheter sizing and number of open guide injections required. Open guide injections through larger catheters do not provide for the as much resistance, therefore decreasing the need for contrast to be diverted
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing CTO PCI | Evaluates the effect of the DyeVert System on contrast volume administration in patients undergoing clinically-indicated CTO PCI. The system allows monitoring and display of contrast volumes that are manually injected during the procedure which will be compared to physician entered contrast usage thresholds during angiographic procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DyeVert System | Device | The DyeVert System (Osprey Medical, Inc) consists of a Contrast Monitoring Wireless Display (CMW) and the DyeVert Plus Disposable Kit which is inclusive of a disposable single-use sterile Smart Syringe and DyeVert Plus Module. |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast volume administration during CTO PCI | The hypothesis of the study is that use of the DyeVert System will result in lower contrast volume, determined through real-time monitoring with the DyeVert System. | During the CTO PCI procedure |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
None
Not provided
Not provided
Not provided
Patients undergoing clinically-indicated chronic total occlusion (CTO) percutaneous coronary intervention (PCI)
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States | ||
| Minneapolis Heart Institute Foundation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Minneapolis |
| Minnesota |
| 55407 |
| United States |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | United States |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |