Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
96 participants
INTERVENTIONAL
2016-04-30
2016-05-31
Brief Summary
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Detailed Description
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The 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.
Randomization 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Treatment
The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.
Diagnostic Coronary Angiogram
Diagnostic angiographic procedure with the use of the DyeVert System.
Control
The control group will include standard of care for diagnostic coronary angiograms.
Diagnostic Coronary Angiogram
Diagnostic angiographic procedure with the use of the DyeVert System.
Interventions
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Diagnostic Coronary Angiogram
Diagnostic angiographic procedure with the use of the DyeVert System.
Eligibility Criteria
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Inclusion Criteria
2. The subject is ≥ 18 years of age
3. The subject is willing and able to provide appropriate informed consent.
Exclusion Criteria
2. Subject has previously been diagnosed with anomalous coronary anatomy
3. Subject has previously underwent coronary artery bypass grafting
4. Subject has severe peripheral artery disease at access site
5. Subject is having a staged PCI
6. The subject is female and currently pregnant
7. In the investigator's opinion, the subject is not considered to be a suitable candidate
18 Years
ALL
No
Sponsors
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Osprey Medical, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Steffen Desch, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Schleswig-Holstein, Lubeck
Locations
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University Hospital of Schleswig-Holstein
Lübeck, , Germany
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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TP-6495
Identifier Type: -
Identifier Source: org_study_id