Endograft treatment in ruptured abdominal aortic aneurysms using the talent® AUI stentgraft system. Design of a feasibility study

Objectives. To study the outcome of patients with ruptured AAA treated by EVAR using the Talent(R) AUI stentgraft system. Design. A multicenter prospective consecutive patient cohort of 100 patients. Materials. Consecutive patients with ruptured AAA will be screened for treatment by EVAR. All patients screened, including those excluded from EVAR, will be clustered and called the study group. The study group will be compared with a historical group of patients with ruptured AAA derived from literature. The New ERA study started February 2003. Outcome. Main outcome events are applicability rate and operative mortality rate of the study group. Conclusion. The study rationale and design are reported here.