The Vascutek Custom Fenestrated Anaconda Post-Market Surveillance Study

Abdominal Aortic Aneurysms (AAA) Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01826344
• Other study ID #: CFD001
• Status: Terminated
• Phase: N/A
• First received: April 3, 2013
• Last updated: December 8, 2015
• Start date: June 2010
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Vascutek Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 628
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysms (AAA)
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Locations

Country	Name	City	State
Austria	Kaiser Franz Josef Spital	Vienna
Austria	Krankenhaus Hietzing	Vienna
Belgium	Imelda Hospital	Bonheiden
Belgium	St Luc Brussels	Brussels
Belgium	University Hospital, Brussels	Brussels
Belgium	Grand Hôpital de Charleroi	Charleroi
Belgium	H.-Hartziekenhuis Roeselare-Menen	Roeselare
Canada	Peter Lougheed Centre	Calgary
Canada	QE2 Hospital	Halifax
Canada	London Health Sciences Centre	London, Ontario
Canada	Royal Victoria Hospital	Montreal
Canada	The Ottawa Hospital	Ottawa
Canada	St Clare's Mercy Hospital	St Johns
Canada	Toronto General Hospital	Toronto
Canada	Health Science Centre	Winnipeg
France	Hopital Pellegrin	Bordeaux
France	CHU Henri Mondor	Creteil
France	Chirurgien Vasculaire	Draguignan
France	Clinique Ambrose Paré	Nancy
France	La Pitie	Paris
France	Le Plessis Robinson	Paris
France	CHU Tours	Tours
Germany	Luisenhospital - Aachen	Aachen
Germany	University Hospital Aachen	Aachen
Germany	Klinikum Augsburg	Augsburg
Germany	Red Cross hospital clinic	Bremen
Germany	University of Cologne	Cologne
Germany	Klinikum Frankfurt Hochst	Frankfurt
Germany	Universitatsklinikum Freiburg	Freiburg
Germany	Krankenhaus Freital	Freital
Germany	Chirurgie am Waldweg	Goettingen
Germany	University of Groningen	Groningen
Germany	Asklepios Klinik Altona	Hamburg
Germany	Medical Care Centre for Vascular Diseases	Hamm
Germany	Marienhospital	Kevelaer
Germany	Bonifacius Hospital	Lingen
Germany	University Hospital	Munich
Germany	DRK Krankenhaus Neustrelitz	Neustrelitz
Germany	Krankenhaus Barmherzige Bruder	Regensburg
Germany	University Hospital	Regensburg
Germany	Klinikum Solingen	Solingen
Germany	Marien-Hospital Witten	Witten
Italy	University of Bologna	Bologna
Italy	Ospedale San Francesco	Nuoro
Italy	Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervel	Palermo
Italy	San Filippo Neri Hospital	Rome
Monaco	Centre Cardio Thoracique	Monaco
Netherlands	Jeroen Bosch Hospital	Den Bosch
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Maastricht University Medical Centre	Maastricht
Netherlands	Erasmus University	Rotterdam
Netherlands	Isala Klinieken	Zwolle
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital de Navarra	Pamplona
Spain	Hospital Universitari Parc Tauli	Sabadell
Spain	Hospital Donostia	San Sebastian
Sweden	Uppsala University	Uppsala
Switzerland	University Hospital Bern	Bern
Switzerland	Kantonsspital Graubunden	Chur
United Kingdom	Royal Derby Hospital	Derby
United Kingdom	Frimley Park Hospital	Frimley
United Kingdom	Western Infirmary/Gartnavel	Glasgow
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	Leicester Royal Infirmary	Leicester
United Kingdom	Imperial (St Mary's / Charing X) Hospital	London
United Kingdom	Kings College Hospital	London
United Kingdom	The Royal Free Hospital	London
United Kingdom	The Royal London Hospital	London
United Kingdom	Freeman Hospital	Newcastle
United Kingdom	John Radcliffe Hospital	Oxford
United Kingdom	Royal Preston Hospital	Preston

Sponsors (1)

Lead Sponsor	Collaborator
Vascutek Ltd.

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  France,  Germany,  Italy,  Monaco,  Netherlands,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To monitor the the post-market clinical safety and effectiveness of the Vascutek AnacondaTM Custom Fenestrated Stent Graft	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.	For 5 years post-implant	No