PURPOSE: The aim of this study was to provide an update regarding the US clinical trial assessing the performance of the @entity11557 Endovascular Graft in the treatment of @entity1028 . MATERIALS AND METHODS: A prospective, nonrandomized, concurrent control-based study design was used to contrast conventional repair of @entity439 with endovascular repair in @entity1 that would otherwise be candidates for open surgical procedures. Additional study arms allow high-physiologic-risk @entity1 and roll-in @entity1 to be treated using the same endovascular device in a registry format. @entity1 were evaluated clinically and radiographically computed tomography (CT) and abdominal radiographs) before any intervention, at hospital discharge, 30 days, 6 months, 12 months, and yearly thereafter. Data were analyzed with the intent of assessing acute and chronic morbidity and mortality, radiographic parameters indicative of successful @entity439 repair, and device integrity. RESULTS: A total of 352 @entity1 were treated with the Zenith graft (one @entity1 did not receive an implant in the standard-risk group), and 80 @entity1 underwent conventional surgical repair. Two hundred @entity1 were enrolled in the standard-risk group, 100 in the high-risk group, and 52 underwent endovascular repair as roll-in @entity1 . All cause mortality, @entity204 , and @entity397 were statistically identical between the groups. Procedural morbidity was significantly lower for @entity1 treated with endovascular grafts with respect to @entity455 . Secondary interventions were more commonly required in the endovascular group. The endoleak rate was 4.9% at 12 months in the standard-risk endovascular group. There was one rupture in the high-risk subset of @entity1 and 3 elective conversions. A total of 1.6% of the endovascular @entity1 were noted to have a barb separation without evidence of significant migration or clinical events. No other device integrity issues were observed. CONCLUSIONS: The safety of the Zenith endovascular graft was superior to conventional management with respect to morbidity and clinical utility. The short-term device efficacy was satisfactory; however, longer-term follow-up will be necessary to establish the duration of this observation.

The @entity11557 endovascular graft for XXXX : clinical update.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient'] @entity11557 :: ('MESH:C565230', 'Disease') :: ['Zenith AAA'] @entity455 :: ('MESH:D014652', 'Disease') :: ['cardiac, pulmonary, renal, and vascular complications'] @entity439 :: ('MESH:D000783', 'Disease') :: ['infrarenal aneurysms', 'aneurysm'] @entity397 :: ('MESH:D012421', 'Disease') :: ['ruptures'] @entity204 :: ('MESH:D003643', 'Disease') :: ['aneurysm-related deaths'] @entity1028 :: ('MESH:D017544', 'Disease') :: ['abdominal aortic aneurysms']
@entity1028 :: (MESH:D017544,Disease) :: ['abdominal aortic aneurysms']
