Status:
TERMINATED
The Vascutek Custom Fenestrated Anaconda Post-Market Surveillance Study
Lead Sponsor:
Vascutek Ltd.
Conditions:
Abdominal Aortic Aneurysms (AAA)
Eligibility:
All Genders
18+ years
Brief Summary
This is a multicentre, prospective, observational post-market registry (follow-up 1 month, 1 year, 2 years, 3 years, 4 years and 5 years) to monitor the post-market clinical safety and effectiveness o...
Detailed Description
AnacondaTM Custom Fenestrated Devices (CFD) are designed for the endovascular repair of abdominal aortic aneurysms (AAA) for cases where the aneurysm extends superiorly very close to or involving the ...
Eligibility Criteria
Inclusion
- 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
- Ruptured or symptomatic aneurysm
- Clinically significant concomitant medical disease or infection
- Connective Tissue Disease (e.g. Marfan's Syndrome)
- Known allergy to nitinol, polyester or contrast medium
- Excessive tortuosity of access vessels (femoral or iliac arteries)
- Landing zone of less than 10mm in the visceral segment of the aorta
- Inability to comply to follow up protocol
- Access vessels less than 6mm in diameter
- Diseased or excessively tortuous access to target vessels
- Target vessels of less than 5mm in calibre
- Excessive calcification or thrombus at the intended landing zone which could affect sealing
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
628 Patients enrolled
Trial Details
Trial ID
NCT01826344
Start Date
June 1 2010
End Date
December 1 2015
Last Update
December 9 2015
Active Locations (71)
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1
Kaiser Franz Josef Spital
Vienna, Austria
2
Krankenhaus Hietzing
Vienna, Austria
3
Imelda Hospital
Bonheiden, Belgium
4
St Luc Brussels
Brussels, Belgium