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The purpose of this registry-based study is to evaluate the ongoing, real-world clinical performance and safety of commercially available DyeVert Systems during typical clinical use for patients undergoing coronary or peripheral angiography for diagnostic and/or interventional procedures.
Contrast-induced acute kidney injury (CI-AKI) occurs in 3-19% of patients undergoing coronary angiography and is associated with increased morbidity, mortality, and healthcare costs. Patients with chronic kidney disease have greater odds of developing CI-AKI. Guidelines for CI-AKI prevention include screening for risk, volume expansion, and minimizing contrast media volume (CMV) to the patient during angiography; however, hospitals face barriers to implementation in the real-world setting and therefore consistent care delivery for at-risk patients remains a modern clinical challenge. DyeVert Systems provide real-time CMV monitoring and minimization during angiography procedures thereby reducing total CMV to the patient and total CMV relative to baseline renal function, two known risk factors for CI-AKI. The DyeMINISH Registry is designed to evaluate ongoing real-world clinical performance and safety of commercially available DyeVert Systems among a large, real-world population of patients undergoing coronary and peripheral angiography.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DyeVertâ„¢ Contrast Reduction Systems | Device | Osprey Medical DyeVertâ„¢ Contrast Reduction Systems (DyeVert Systems) provide fluid pathway resistance modulation such that excess contrast media (CM) (i.e. CM that is not needed for diagnostic or therapeutic purposes) is minimized in the patient's vasculature and total contrast media volume (CMV) reduction occurs, while maintaining adequate image quality. |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate contrast media volume (CMV) threshold setting practices and contrast media (CM) usage during index cath lab procedures in which the DyeVert System was used | Index procedure | |
| Evaluate incidence of adverse events associated with index cath lab procedures in which the DyeVert System was used | Index procedure through 120 days post index procedure |
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Inclusion Criteria:
Exclusion Criteria:
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DyeVert Systems are indicated for patients undergoing angiographic procedures requiring injection of contrast media. Patients at risk for developing contrast-induced nephropathy (CIN) represent the target population for these devices.
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| Name | Affiliation | Role |
|---|---|---|
| Anand Prasad, MD, FACC | UT Health Science Center San Antonio: Prof of Medicine & Director Cardiac Catheterization Laboratory | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Healthcare | Hartford | Connecticut | 06102 | United States | ||
| Steward Palmetto General Hospital |
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| Hialeah |
| Florida |
| 33016 |
| United States |
| Emory Healthcare | Atlanta | Georgia | 30322 | United States |
| Atlanta VA Medical Center | Decatur | Georgia | 30033 | United States |
| Midwest Heart & Vascular Specialists | Overland Park | Kansas | 66211 | United States |
| St. Elizabeth Healthcare | Edgewood | Kentucky | 41017 | United States |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | United States |
| The University of Texas Health Science Center | San Antonio | Texas | 78229 | United States |
| CHRISTUS Health-Westover Hills | San Antonio | Texas | 78251 | United States |
| St. Mary's Medical Center | Huntington | West Virginia | 25702 | United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |