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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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21 December 2015 |
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Main ID: |
NCT01826344 |
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Date of registration:
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03/04/2013 |
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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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The Vascutek Custom Fenestrated Anaconda Post-Market Surveillance Study
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Scientific title:
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Date of first enrolment:
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June 2010 |
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Target sample size:
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628 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01826344 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Observational Model: Cohort, 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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Austria
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Belgium
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Canada
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France
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Germany
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Italy
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Monaco
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Netherlands
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Spain
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Sweden
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Switzerland
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion Criteria:
A patient with juxta renal abdominal aortic aneurysms (AAA) who, in the opinion of the
treating physician, is anatomically suitable for the Anaconda Fenestrated Graft and for
whom a customised medical device is required.
Exclusion Criteria:
1. Ruptured or symptomatic aneurysm
2. Clinically significant concomitant medical disease or infection
3. Connective Tissue Disease (e.g. Marfan's Syndrome)
4. Known allergy to nitinol, polyester or contrast medium
5. Excessive tortuosity of access vessels (femoral or iliac arteries)
6. Landing zone of less than 10mm in the visceral segment of the aorta
7. Inability to comply to follow up protocol
8. Access vessels less than 6mm in diameter
9. Diseased or excessively tortuous access to target vessels
10. Target vessels of less than 5mm in calibre
11. Excessive calcification or thrombus at the intended landing zone which could affect
sealing
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Abdominal Aortic Aneurysms (AAA)
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Primary Outcome(s)
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To monitor the the post-market clinical safety and effectiveness of the Vascutek AnacondaTM Custom Fenestrated Stent Graft
[Time Frame: For 5 years post-implant]
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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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