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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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30 May 2016 |
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Main ID: |
NCT02436642 |
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Date of registration:
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04/05/2015 |
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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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AVERT Plus Post-Market Registry
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Scientific title:
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AVERT Plus Post-Market Registry |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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20 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02436642 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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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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Universitatsklinikum Schleswig-Holstein (Campus Lubeck) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Scheduled for a coronary diagnostic or PCI procedure using manual manifold injection
with the AVERT System and CMS according to the labeled indications for these devices.
- Patient consent to participate
Exclusion Criteria:
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Coronary Artery Disease
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Intervention(s)
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Device: AVERT Plus System
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Primary Outcome(s)
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Contrast media volume usage
[Time Frame: Day of procedure]
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Secondary Outcome(s)
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Contrast media volume savings
[Time Frame: Day of procedure]
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Physician feedback on device features
[Time Frame: Day of procedure]
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Angiographic image quality
[Time Frame: Day of procedure]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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