The Bolton Treovance abdominal stent-graft: European clinical trial design.

Endovascular aortic repair (EVAR) has emerged as a promising, less invasive alternative to conventional open surgery for the treatment of infrarenal abdominal aortic aneurysms (AAAs). In the last 20 years, the application rate of EVAR and its clinical results have significantly improved thanks to the evolution of stent-grafts and endovascular delivery systems. However, further development is still needed to reduce the incidence of complications and secondary re-interventions. The Treovance abdominal aortic stent-graft (Bolton Medical, Barcelona, Spain) is a new-generation endovascular device, developed to increase flexibility, lower profile, improve deployment and sealing mechanisms. In particular, it is provided with some innovative features as a double layer of proximal barbs (suprarenal and infrarenal) for supplemental fixation, dull barbs between modules to avoid potential leg disconnections, detachable outer sheath provided with a new-design hemostatic valve, and a double improved mechanism (slow motion and "pin and pull") for precise stent-graft deployment. A European prospective, non-randomized, multi-institutional, "first-in-human" trial (the ADVANCE trial) was conducted from March to December 2011 to assess the safety and performance of the Treovance stent-graft system before commercialization. Thirty patients with anatomically suitable non-ruptured AAAs were enrolled at five clinical sites in Italy, Spain, and Germany. EVAR was completed successfully in all patients. The stent-graft was delivered and deployed safely even in heavily angulated or calcified anatomies. No 30-day device-related complications nor deaths were observed. Preliminary experience with the Treovance abdominal stent-graft within the ADVANCE trial was satisfactory with regard to technical success and perioperative clinical results. Follow-up data are needed to assess mid- and long-term clinical outcomes, along with durability of this new-generation endovascular device.