Brief Title
The Vascutek Custom Fenestrated Anaconda Post-Market Surveillance Study
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 of the Vascutek AnacondaTM Custom Fenestrated Stent Graft in patients with a
short infrarenal neck of <15mm or juxta-renal abdominal aortic aneurysms who, in the opinion
of the treating physician, are anatomically suitable for the AnacondaTM Custom Fenestrated
Stent Graft and for whom a customised medical device is required.
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 renal arteries, leaving insufficient neck length for infrarenal device
sealing. The non-CE marked devices are custom designed based on CT scan data of the patient's
aorta and regulated in accordance with the Medical Device Directive (93/42/EEC) and
associated country specific regulations as applicable.
The proximal end of the AnacondaTM fenestrated body device is positioned suprarenally, where
it seals and fixates in the vessel by means of rings comprised of multiple turns of fine
nitinol wire, attached to the fabric with polyester sutures, creating a self-expanding stent
which provides a conformable seal with the vessel wall and assists in anchoring of the
device. Nitinol hooks provide secure fixation within the suprarenal aorta. The saddle shape
of the rings allows the superior mesenteric artery (SMA) or celiac artery to be accommodated
in the valley of the top ring saddle in some cases.
The objective of the registry is to provide long term (5 year) safety and effectiveness data
of all patients who consent to their data to be used in the registry. This data aims to
demonstrate that the Vascutek AnacondaTM Custom Fenestrated Stent Graft is safe and effective
in patients with a short infrarenal neck of <15mm or juxta-renal abdominal aortic aneurysms
who, in the opinion of the treating physician, are anatomically suitable for the AnacondaTM
Custom Fenestrated Stent Graft.
Study Type
Observational [Patient Registry]
Primary Outcome
To monitor the the post-market clinical safety and effectiveness of the Vascutek AnacondaTM Custom Fenestrated Stent Graft
Condition
Abdominal Aortic Aneurysms (AAA)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
628
Start Date
June 2010
Completion Date
December 2015
Primary Completion Date
December 2015
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT01826344
Organization ID
CFD001
Responsible Party
Sponsor
Study Sponsor
Vascutek Ltd.
Study Sponsor
, ,
Verification Date
December 2015