The Vascutek Custom Fenestrated Anaconda Post-Market Surveillance Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Vascutek Ltd.
Sponsor:
Information provided by (Responsible Party):
Vascutek Ltd.
ClinicalTrials.gov Identifier:
NCT01826344
First received: April 3, 2013
Last updated: July 8, 2013
Last verified: July 2013

April 3, 2013
July 8, 2013
June 2010
June 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01826344 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Vascutek Custom Fenestrated Anaconda Post-Market Surveillance Study
Not Provided

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.

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.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
5 Years
Not Provided
Non-Probability Sample

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.

Abdominal Aortic Aneurysms (AAA)
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
Not Provided
Not Provided
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Dr Peter Bungay peter.bungay@derbyhospitals.nhs.uk
Austria,   Belgium,   Canada,   France,   Germany,   Italy,   Monaco,   Netherlands,   Spain,   Sweden,   Switzerland,   United Kingdom
 
NCT01826344
CFD001
No
Vascutek Ltd.
Vascutek Ltd.
Not Provided
Not Provided
Vascutek Ltd.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP