Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-31 @ 9:53 PM
Study NCT ID:
NCT03825094
Status:
UNKNOWN
Last Update Posted:
2022-04-18
First Post:
2019-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DyeVert™ System for Contrast Monitoring in At-Risk Patients Undergoing Angiography: A Real-World Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-14', 'studyFirstSubmitDate': '2019-01-29', 'studyFirstSubmitQcDate': '2019-01-29', 'lastUpdatePostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': 'Index procedure'}, {'measure': 'Evaluate incidence of adverse events associated with index cath lab procedures in which the DyeVert System was used', 'timeFrame': 'Index procedure through 120 days post index procedure'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Patients at Risk for Developing Contrast-induced Nephropathy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* DyeVert Group Patients: Patient underwent a diagnostic and/or interventional angiography procedure in which the DyeVert System was used in a majority of the case\n* Patient is willing and able to provide appropriate informed consent (if required)\n\nExclusion Criteria:\n\n* Required data was not collected or is not available\n* In the Investigator or Sponsor's opinion, the patient is not considered to be suitable"}, 'identificationModule': {'nctId': 'NCT03825094', 'acronym': 'DyeMINISH', 'briefTitle': 'DyeVert™ System for Contrast Monitoring in At-Risk Patients Undergoing Angiography: A Real-World Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Osprey Medical, Inc'}, 'officialTitle': 'DyeVert™ System Use for Contrast Monitoring and Minimization in At-Risk Patients Undergoing Angiography Procedures: A Real-World Registry (DyeMINISH Registry)', 'orgStudyIdInfo': {'id': 'TP-6647'}}, 'armsInterventionsModule': {'interventions': [{'name': 'DyeVert™ Contrast Reduction Systems', 'type': 'DEVICE', 'otherNames': ['DyeVert Systems'], 'description': "Osprey Medical DyeVert™ 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."}]}, 'contactsLocationsModule': {'locations': [{'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Healthcare', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Steward Palmetto General Hospital', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Healthcare', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta VA Medical Center', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Midwest Heart & Vascular Specialists', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '41017', 'city': 'Edgewood', 'state': 'Kentucky', 'country': 'United States', 'facility': 'St. Elizabeth Healthcare', 'geoPoint': {'lat': 39.01867, 'lon': -84.58189}}, {'zip': '38801', 'city': 'Tupelo', 'state': 'Mississippi', 'country': 'United States', 'facility': 'North Mississippi Medical Center', 'geoPoint': {'lat': 34.25807, 'lon': -88.70464}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78251', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'CHRISTUS Health-Westover Hills', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '25702', 'city': 'Huntington', 'state': 'West Virginia', 'country': 'United States', 'facility': "St. Mary's Medical Center", 'geoPoint': {'lat': 38.41925, 'lon': -82.44515}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'Anand Prasad, MD, FACC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT Health Science Center San Antonio: Prof of Medicine & Director Cardiac Catheterization Laboratory'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osprey Medical, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}