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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02752802 |
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Date of registration:
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22/04/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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DyeVert System RCT
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Scientific title:
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Single Site Randomized Control Trial Evaluating the DyeVert System |
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Date of first enrolment:
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April 2016 |
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Target sample size:
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96 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02752802 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Steffen Desch, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital of Schleswig-Holstein, Lubeck |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. The subject is indicated for a diagnostic coronary angiogram procedure with a 5 French
catheter only.
2. The subject is = 18 years of age
3. The subject is willing and able to provide appropriate informed consent.
Exclusion Criteria:
1. Subject is undergoing a STEMI procedure
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Coronary Angiography
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Intervention(s)
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Device: Diagnostic Coronary Angiogram
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Primary Outcome(s)
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Evaluate the Total Volume of CM Used Comparing the DyeVert Group to the Control Group.
[Time Frame: All data will be collected on the day of the procedure, over an average of 12 hours.]
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Secondary Outcome(s)
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Assessment of the Quality of Angiographic Images Between Groups
[Time Frame: 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.
[Time Frame: All data will be collected on the day of the procedure, over an average of 12 hours.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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