The GORE EXCLUDER Iliac Branch Endoprosthesis (IBE; W. L. Gore and Associates, Flagstaff, Ariz) is an iliac branch stent graft system designed to preserve internal iliac artery perfusion during endovascular repair of aortoiliac aneurysms (AIAs) and common iliac artery (CIA) aneurysms (CIAAs). We report the 6-month primary end point results of the IBE 12-04 United States pivotal trial for endovascular treatment of AIAs and CIAAs using the IBE device.Methods:
The trial prospectively enrolled 63 patients with AIA or CIAA who underwent implantation of the IBE device at 28 centers in the United States from 2013 to 2015. All patients underwent placement of a single IBE device. Twenty-two patients (34.9%) with bilateral CIAs were enrolled after undergoing staged coil or plug embolization (21 of 22) or surgical revascularization (1 of 22) of the contralateral internal iliac artery. Follow-up at 30 days and 6 months included clinical assessment and computed tomography angiography evaluation as assessed by an independent core laboratory. The primary effectiveness end point was freedom from IBE limb occlusion and reintervention for type I or III endoleak and ≥60% stenosis at 6 months, and the secondary effectiveness end point was freedom from new onset of buttock claudication on the IBE side at 6 months.Results:
Mean CIA diameter on the IBE side was 41.0 ± 11.4 mm (range, 25.2-76.3 mm). There were no procedural deaths, and technical success, defined as successful deployment and patency of all IBE components and freedom from type I or III endoleak, was 95.2% (60 of 63). Data for 61 patients were available for primary and secondary effectiveness end point analysis. Internal iliac limb patency was 95.1% (58 of 61), and no new type I or III endoleaks or device migrations were observed at 6 months. The three patients with loss of internal iliac limb patency were asymptomatic, and freedom from new-onset buttock claudication on the IBE side was 100% at 6 months. New-onset buttock claudication occurred on the non-IBE treatment side in six of 21 patients (28.6%) who underwent staged internal iliac artery coil embolization.Conclusions:
These results confirm that the IBE device is effective at treating CIAAs and AIAs, maintaining blood flow into the internal iliac artery, and avoiding complications associated with internal iliac artery sacrifice. Follow-up will be continued for 5 years to establish the long-term durability of iliac aneurysm repair with the IBE device.