Study Summary

An abdominal aortic aneurysm (AAA) is a ‘bulge’ caused by weakness of the wall of the aorta (main blood vessel) in the section that travels down through the abdomen.  An AAA can grow to a large size over time and it may burst (rupture), causing life-threatening internal bleeding.  The standard method to prevent the AAA from bursting is to re-line the aorta with an artificial piece of rigid tubing called a stent that has been covered with material.  This is inserted through the blood vessels from the artery in the groin to stop the aneurysm from expanding and restore normal diameter of the aorta.  This is commonly known as a ‘keyhole’ or minimally invasive approach called Endovascular (i.e. inside the aorta) aneurysm repair (EVAR). 

There have been many advances in stent-graft technology to improve the accuracy and effectiveness of the EVAR procedure.  A new design of an existing stent-graft that is currently being used in patients in many hospitals is the GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL (also known as EXCC Device).  This new device allows the doctor to shape the upper end of the stent-graft so that it may be placed into the aorta more accurately, matching the shape of the aorta.  This modification means the graft should stay fixed in position and reduce the need for any further procedures. 

BSET-CLEVAR study is an observational data collection effort called a registry involving patients with AAA who are undergoing routine treatment of their aneurysm using the EXCC device.  Recruitment will take place in approximately 20 experienced UK centres with extensive EVAR experience. Up to 200 participants will be recruited over 12 months followed-up to 1-year (participants will not undergo any procedure that is not part of their routine clinical care).  By collecting details about the performance of the EXCC Device, the study team hopes to learn more about how accurate the device is when placed. A more accurate and effective placement will potentially translate to improved effectiveness of this device over time, improving the care of patients like you. 

Contact for patients, relatives and carers:

If you are a patient taking part in this study or a relative or carer of a study participant and you would like more information about the study please contact:

Dr Pinar Ulug (National Study Manager)

We will be happy to discuss any concerns you have with the study or answer your questions.

Useful links

For independent advice about taking part in research, you can visit: https://www.imperial.nhs.uk/research/taking-part

More information on vascular diseases or procedures are also available from:

• The Circulation Foundation
• The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance (recommendations) on whether interventional procedures are safe enough and work well enough to be used routinely in the NHS.  You can read the NICE guidance on stent-graft placement in abdominal aortic aneurysms here.