Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-02-26 @ 2:16 AM
Study NCT ID:
NCT02752802
Status:
COMPLETED
Last Update Posted:
2017-02-28
First Post:
2016-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
DyeVert System RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mshepard@ospreymed.com', 'phone': '952-955-8236', 'title': 'Michele Shepard, Vice President of Clinical Affairs', 'organization': 'Osprey Medical, Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'At point of discharge from index procedure, approximetly 12 hours.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': 'The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.\n\nDiagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System.', 'otherNumAtRisk': 48, 'otherNumAffected': 2, 'seriousNumAtRisk': 48, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Control', 'description': 'The control group will include standard of care for diagnostic coronary angiograms.\n\nDiagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System.', 'otherNumAtRisk': 48, 'otherNumAffected': 3, 'seriousNumAtRisk': 48, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'General Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders'}], 'seriousEvents': [{'term': 'Extended Hospital Stay', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Evaluate the Total Volume of CM Used Comparing the DyeVert Group to the Control Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.\n\nDiagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System.'}, {'id': 'OG001', 'title': 'Control', 'description': 'The control group will include standard of care for diagnostic coronary angiograms.\n\nDiagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.0', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '62.5', 'spread': '12.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'All data will be collected on the day of the procedure, over an average of 12 hours.', 'description': 'DyeVert is intended to reduce the total amount of contrast media (CM) administered during procedures requiring the injection of contrast media. Clinical evidence has demonstrated that CM can be toxic to the kidneys, leading to contrast induced nephropathy (CIN)', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assessment of the Quality of Angiographic Images Between Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'units': 'Images', 'counts': [{'value': '399', 'groupId': 'OG000'}, {'value': '404', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'The control group will include standard of care for diagnostic coronary angiograms.\n\nDiagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System.'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.\n\nDiagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System.'}], 'classes': [{'categories': [{'measurements': [{'value': '379', 'groupId': 'OG000'}, {'value': '386', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'AlAll data will be collected on the day of the procedure, over an average of 12 hours.', 'description': 'To assess the adequacy of the image quality. The proportion of images in which contrast opacification is deemed sufficient to evaluate the desired anatomical structures adequately will be compared between the DyeVert and control groups.', 'unitOfMeasure': 'Images', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Images', 'denomUnitsSelected': 'Images'}, {'type': 'SECONDARY', 'title': 'Assessment of Incidence of Serious Adverse Device Effect for Subjects Treated With the DyeVert System During the Procedure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.\n\nDiagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'All data will be collected on the day of the procedure, over an average of 12 hours.', 'description': 'To assess the incidence of Serious Adverse Device Effect for subjects treated with the DyeVert System during the procedure for treatment subjects only.', 'unitOfMeasure': 'Number of Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Only treatments subjects were analyzed for this endpoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': 'The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.\n\nDiagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System.'}, {'id': 'FG001', 'title': 'Control', 'description': 'The control group will include standard of care for diagnostic coronary angiograms.\n\nDiagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Contrast Volume Not Collected', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': 'The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.\n\nDiagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System.'}, {'id': 'BG001', 'title': 'Control', 'description': 'The control group will include standard of care for diagnostic coronary angiograms.\n\nDiagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.6', 'spread': '13.6', 'groupId': 'BG000'}, {'value': '66.2', 'spread': '12.8', 'groupId': 'BG001'}, {'value': '67.4', 'spread': '13.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-09', 'studyFirstSubmitDate': '2016-04-22', 'resultsFirstSubmitDate': '2016-11-04', 'studyFirstSubmitQcDate': '2016-04-22', 'lastUpdatePostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-09', 'studyFirstPostDateStruct': {'date': '2016-04-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the Total Volume of CM Used Comparing the DyeVert Group to the Control Group.', 'timeFrame': 'All data will be collected on the day of the procedure, over an average of 12 hours.', 'description': 'DyeVert is intended to reduce the total amount of contrast media (CM) administered during procedures requiring the injection of contrast media. Clinical evidence has demonstrated that CM can be toxic to the kidneys, leading to contrast induced nephropathy (CIN)'}], 'secondaryOutcomes': [{'measure': 'Assessment of the Quality of Angiographic Images Between Groups', 'timeFrame': 'AlAll data will be collected on the day of the procedure, over an average of 12 hours.', 'description': 'To assess the adequacy of the image quality. The proportion of images in which contrast opacification is deemed sufficient to evaluate the desired anatomical structures adequately will be compared between the DyeVert and control groups.'}, {'measure': 'Assessment of Incidence of Serious Adverse Device Effect for Subjects Treated With the DyeVert System During the Procedure.', 'timeFrame': 'All data will be collected on the day of the procedure, over an average of 12 hours.', 'description': 'To assess the incidence of Serious Adverse Device Effect for subjects treated with the DyeVert System during the procedure for treatment subjects only.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contrast Media', 'Angiography'], 'conditions': ['Coronary Angiography']}, 'referencesModule': {'references': [{'pmid': '25074372', 'type': 'BACKGROUND', 'citation': 'Brown JR, Solomon RJ, Sarnak MJ, McCullough PA, Splaine ME, Davies L, Ross CS, Dauerman HL, Stender JL, Conley SM, Robb JF, Chaisson K, Boss R, Lambert P, Goldberg DJ, Lucier D, Fedele FA, Kellett MA, Horton S, Phillips WJ, Downs C, Wiseman A, MacKenzie TA, Malenka DJ; Northern New England Cardiovascular Disease Study Group. Reducing contrast-induced acute kidney injury using a regional multicenter quality improvement intervention. Circ Cardiovasc Qual Outcomes. 2014 Sep;7(5):693-700. doi: 10.1161/CIRCOUTCOMES.114.000903. Epub 2014 Jul 29.'}, {'pmid': '11079656', 'type': 'BACKGROUND', 'citation': 'Gruberg L, Mintz GS, Mehran R, Gangas G, Lansky AJ, Kent KM, Pichard AD, Satler LF, Leon MB. The prognostic implications of further renal function deterioration within 48 h of interventional coronary procedures in patients with pre-existent chronic renal insufficiency. J Am Coll Cardiol. 2000 Nov 1;36(5):1542-8. doi: 10.1016/s0735-1097(00)00917-7.'}, {'pmid': '19830793', 'type': 'BACKGROUND', 'citation': 'Klein LW, Sheldon MW, Brinker J, Mixon TA, Skelding K, Strunk AO, Tommaso CL, Weiner B, Bailey SR, Uretsky B, Kern M, Laskey W; Interventional Committee of the Society for Cardiovascular Angiography and Interventions. The use of radiographic contrast media during PCI: a focused review: a position statement of the Society of Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2009 Nov 1;74(5):728-46. doi: 10.1002/ccd.22113. No abstract available.'}, {'pmid': '23394215', 'type': 'BACKGROUND', 'citation': 'Lameire N, Kellum JA; KDIGO AKI Guideline Work Group. Contrast-induced acute kidney injury and renal support for acute kidney injury: a KDIGO summary (Part 2). Crit Care. 2013 Feb 4;17(1):205. doi: 10.1186/cc11455.'}, {'pmid': '8622223', 'type': 'BACKGROUND', 'citation': 'Levy EM, Viscoli CM, Horwitz RI. The effect of acute renal failure on mortality. A cohort analysis. JAMA. 1996 May 15;275(19):1489-94.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the amount of contrast media (CM) saved using the DyeVert system in diagnostic angiographic procedures compared to a control group.', 'detailedDescription': 'This is a prospective, randomized, parallel group, single center clinical evaluation of the DyeVert System. Subjects undergoing a diagnostic coronary angiogram procedure with a 5 French catheter are eligible to participate in this study. The treatment group will use the DyeVert System.\n\nThe trial will be conducted at one center, located in Germany. A sample size of 96 evaluable subjects will provide a sufficient number of samples to evaluate the primary objectives.\n\nRandomization will occur following confirmation that the subject meets the inclusion/exclusion criteria and has signed an informed consent. Subjects that are anticipated to be a diagnostic only procedure, but end up being an ad-hoc PCI, can still remain enrolled in the trial. If a subject proceeds to a PCI, data will only be collected through the diagnostic portion of the case.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The subject is indicated for a diagnostic coronary angiogram procedure with a 5 French catheter only.\n2. The subject is ≥ 18 years of age\n3. The subject is willing and able to provide appropriate informed consent.\n\nExclusion Criteria:\n\n1. Subject is undergoing a STEMI procedure\n2. Subject has previously been diagnosed with anomalous coronary anatomy\n3. Subject has previously underwent coronary artery bypass grafting\n4. Subject has severe peripheral artery disease at access site\n5. Subject is having a staged PCI\n6. The subject is female and currently pregnant\n7. In the investigator's opinion, the subject is not considered to be a suitable candidate"}, 'identificationModule': {'nctId': 'NCT02752802', 'briefTitle': 'DyeVert System RCT', 'organization': {'class': 'INDUSTRY', 'fullName': 'Osprey Medical, Inc'}, 'officialTitle': 'Single Site Randomized Control Trial Evaluating the DyeVert System', 'orgStudyIdInfo': {'id': 'TP-6495'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment', 'description': 'The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.', 'interventionNames': ['Device: Diagnostic Coronary Angiogram']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'The control group will include standard of care for diagnostic coronary angiograms.', 'interventionNames': ['Device: Diagnostic Coronary Angiogram']}], 'interventions': [{'name': 'Diagnostic Coronary Angiogram', 'type': 'DEVICE', 'description': 'Diagnostic angiographic procedure with the use of the DyeVert System.', 'armGroupLabels': ['Control', 'Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23538', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'University Hospital of Schleswig-Holstein', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}], 'overallOfficials': [{'name': 'Steffen Desch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Schleswig-Holstein, Lubeck'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osprey Medical, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}