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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT01609270 |
Date of registration:
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25/05/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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CardioRoot Post-Marketing Surveillance Registry
CardioRoot |
Scientific title:
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CardioRoot Post-Marketing Surveillance Registry |
Date of first enrolment:
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November 2013 |
Target sample size:
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52 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01609270 |
Study type:
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Observational |
Study design:
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Phase:
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Countries of recruitment
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Czech Republic
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Czechia
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France
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Germany
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Italy
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patients requiring a CardioRoot graft as per the CardioRoot Instructions for Use (IFU)
Exclusion Criteria:
- patients with contra-indications per CardioRoot IFU
- patients requiring consecutive aortic surgery
- patients with coronary artery disease
- patients who require urgent or emergent surgery
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cardiovascular Surgical Procedure
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Intervention(s)
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Device: CardioRoot graft
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Primary Outcome(s)
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Graft complications
[Time Frame: 30 days]
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Graft complications
[Time Frame: 1 year]
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Secondary Outcome(s)
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Subject mortality rate
[Time Frame: 30 days, 1 year]
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Secondary ID(s)
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MCV00008317
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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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