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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16 March 2021 |
Main ID: |
NCT01082172 |
Date of registration:
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04/03/2010 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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South American Thoracic Stent-Graft Study
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Scientific title:
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A Pilot Trial to Evaluate the Performance of the TriVascular Thoracic Stent Graft System |
Date of first enrolment:
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November 2009 |
Target sample size:
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2 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01082172 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. 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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Brazil
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Chile
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- The TriVascular Thoracic Stent Graft System is indicated in subjects diagnosed with an
aneurysm in the descending thoracic aorta having vascular morphology suitable for
endovascular repair, including:
- Adequate iliac/femoral access compatible with the required delivery systems,
- Non-aneurysmal aortic segments proximal and distal to the aneurysm.
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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Thoracic Aortic Aneurysm
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Intervention(s)
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Device: Implant Thoracic Stent Graft
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Primary Outcome(s)
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Absence of device-related serious adverse events within 30-days of endovascular procedure
[Time Frame: 30-Days]
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Secondary ID(s)
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771-0001 TAA Trial
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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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