Title: Ascending Thoracic Aortic Graft (ATAG)
Funder: Department of Health (England)

Abstract: Background Ascending Thoracic Aneurysm (ATA) and Ascending Aortic Dissection (AAD) are increasingly common. Current gold standard treatment for both conditions is highly invasive open cardiac surgery. Despite refined surgical techniques 30% of patients with AAD die within the first 48 hours, & only 50% survive to discharge. Many patients refuse or are turned down for surgery because of co-morbidity or perceived surgical risk despite the fact that in AAD medical treatment is associated with a doubling of mortality [Circ 2002;105:200]. Endovascular stent treatment of descending aortic aneurysm and dissection is the current treatment of choice, but these devices cannot be used for treatment of the ascending aorta because they are not designed to preserve coronary blood flow and aortic valve integrity.? Aims To develop & test an Ascending Thoracic Aortic Graft (ATAG) - a novel covered stent graft designed specifically to treat both ATA and AAD, protecting coronary blood flow and aortic valve integrity. 1) Design and develop a 2nd generation ATAG prototype for testing (1st generation testing completed – see Annex 4 page 10) 2) Perform in-vitro prototype graft testing programme (glass model/flow rig) 3) In-vitro delivery system design and development programme 4) In-vivo development programme, including acute and in-vivo survival / safety data 5) Development of IP / business plan to take ATAG to market All device testing will be performed by the investigator team. Design and device manufacture / regulatory approval will be outsourced to Qualimed. Plan of Investigation A review of aortic size and coronary anatomy in healthy and diseased states has been undertaken and this information was integral to the formulation of the ATAG design specification document. Both documents are found within Annex 4 (WP1 and 2 from original application as requested by FPD2 Committee). PLAN 1) Design and develop specification for a 2nd generation ATAG prototype ready for in-vitro and in-vivo testing 2) Perform in-vitro prototype graft testing (glass model and flow rig tests) 3) Design, develop and test delivery system using in-vitro flow rig 4) Conduct in-vivo evaluations of ATAG and delivery system in acute and survival animal models in readiness for first in man (FIM) trials 5) Develop IP / business plan to take device to market Potential Impact The world Authority on aortic dissection - The International Registry of Aortic Dissection (IRAD) Centres report a surgical turn down rate of 21% in patients presenting with AAD. 90% of these patients not treated surgically will be dead at 3 months [Circ 2002;105:200-206]. Surgery for both AAD and ATA is highly invasive, with cardio-pulmonary bypass, deep circulatory arrest, and a prolonged intensive care stay. Endovascular stent treatment has revolutionized the treatment of aortic dissection and aneurysm in the abdominal and descending thoracic aorta [NEJM 351 (16):1607-18]. The ATAG intends to take this revolution to the ascending aorta allowing more patients access to life saving percutaneous treatment, more quickly with less morbidity and mortality than conventional surgery.


Research activity codes: 5.3 MEDICAL DEVICES
Health categories: CARDIOVASCULAR