Global Fenestrated Anaconda™ Clinical Study
Research type
Research Study
Full title
A Prospective, Global, Multicentre, Real World Outcome Study of Fenestrated Endovascular Aneurysm Repair using the Fenestrated Anaconda™ device
IRAS ID
229957
Contact name
Robin Williams
Contact email
Sponsor organisation
Vascutek Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
12 years, 0 months, 1 days
Research summary
The Vascutek Fenestrated Anaconda™ device is used for the treatment of Abdominal Aortic Aneurysm (AAA). The aorta is a major blood vessel that runs from the heart through the chest and abdomen. An AAA is a balloon-like bulge in the wall of the blood vessel caused by weakening of the blood vessel wall. If left untreated this can burst. Traditionally, aneurysms were treated with open surgery, where the surgeon cuts into the abdomen and replaces the weakened section with a tube (graft) made of fabric. Now, a minimally invasive (keyhole) procedure using a fabric tube held open by wire (stent-graft) is usually preferred, and is known as an Endovascular Aneurysm Repair (EVAR). The Fenestrated Anaconda™ device is a type of stent-graft which is custom made for each individual patient.
The Fenestrated Anaconda™ custom made device has been available since 2010. As of July 2017, over 2000 Fenestrated Anaconda™ devices have been implanted. Vascutek Ltd is the device manufacturer, and is also funding this study. The purpose of this study is to collect information which will help to give surgeons and the device manufacturer feedback on the long-term safety and performance of the device. Only patients who would be routinely given a Fenestrated Anaconda™ device are allowed to participate in the study, and the study does not require patients to have any additional medical or surgical procedures beyond those that they would normally have to treat their condition. The information being collected includes relevant details of patient’s medical history, measurements of their aneurysm before and after surgery, blood test results, and details of any complications that occur during or after their operation. After the operation the study will collect health information about the patient and their Fenestrated Anaconda™ device for the next 10 years at the patient’s routine follow-up appointments.REC name
North East - York Research Ethics Committee
REC reference
17/NE/0331
Date of REC Opinion
23 Dec 2017
REC opinion
Further Information Favourable Opinion