DyeVert System RCT
Single Site Randomized Control Trial Evaluating the DyeVert System
研究概览
详细说明
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.
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Lübeck、德国、23538
- University Hospital of Schleswig-Holstein
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- The subject is indicated for a diagnostic coronary angiogram procedure with a 5 French catheter only.
- The subject is ≥ 18 years of age
- The subject is willing and able to provide appropriate informed consent.
Exclusion Criteria:
- Subject is undergoing a STEMI procedure
- Subject has previously been diagnosed with anomalous coronary anatomy
- Subject has previously underwent coronary artery bypass grafting
- Subject has severe peripheral artery disease at access site
- Subject is having a staged PCI
- The subject is female and currently pregnant
- In the investigator's opinion, the subject is not considered to be a suitable candidate
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:Treatment
The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.
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Diagnostic angiographic procedure with the use of the DyeVert System.
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有源比较器:Control
The control group will include standard of care for diagnostic coronary angiograms.
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Diagnostic angiographic procedure with the use of the DyeVert System.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Evaluate the Total Volume of CM Used Comparing the DyeVert Group to the Control Group.
大体时间:All data will be collected on the day of the procedure, over an average of 12 hours.
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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)
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All data will be collected on the day of the procedure, over an average of 12 hours.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Assessment of the Quality of Angiographic Images Between Groups
大体时间:AlAll data will be collected on the day of the procedure, over an average of 12 hours.
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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.
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AlAll data will be collected on the day of the procedure, over an average of 12 hours.
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Assessment of Incidence of Serious Adverse Device Effect for Subjects Treated With the DyeVert System During the Procedure.
大体时间:All data will be collected on the day of the procedure, over an average of 12 hours.
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To assess the incidence of Serious Adverse Device Effect for subjects treated with the DyeVert System during the procedure for treatment subjects only.
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All data will be collected on the day of the procedure, over an average of 12 hours.
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合作者和调查者
调查人员
- 首席研究员:Steffen Desch, MD、University Hospital of Schleswig-Holstein, Lubeck
出版物和有用的链接
一般刊物
- 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.
- 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.
- 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.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Diagnostic Coronary Angiogram的临床试验
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Norwegian Institute of Public HealthNorwegian University of Science and Technology完全的
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Norwegian Institute of Public HealthStatistics Norway; Society of Interventional Oncology完全的
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Universitätsklinikum Hamburg-EppendorfGerman Research Foundation; University Hospital Tuebingen完全的