Endovascular Repair of Aortoiliac or Common Iliac Artery Aneurysm Using the Lifetech Iliac Bifurcation Stent Graft System: A Prospective, Multicenter Clinical Study

Abstract Background Sacrifice of the internal iliac artery (IIA) may result in ischemic manifestations after aortoiliac aneurysm (AIA) or common iliac artery aneurysm (CIAA) endovascular repair. This study sought to evaluate the safety and efficacy of a new iliac bifurcation stent graft (IBSG) system for revascularization of the IIA. Methods Patients who underwent implantation of the IBSG at eight centers in China from September 2015 to June 2018 were enrolled. Clinical and computed tomography angiography follow-up assessments were conducted at 30 and 180 days postoperatively. The primary endpoint was the IIA patency rate of the IBSG device at 180 days postoperatively. Secondary endpoints comprised the postoperative technical success rate and clinical success rate at 30 and 180 days. Descriptive statistics and the Clopper-Pearson exact method were used to analyze the data. Results Seventy-three patients (mean age, 69.6 years, 91.8% men) were eligible for this trial, and 59 patients were eligible for primary effectiveness endpoint analysis. AIA was present in 55 patients (75.34%) and CIAA in 18 (24.66%). The iliac artery aneurysms were unilateral in 69 patients (94.52%) and bilateral in four (5.48%). Overall technical success was 89.04% (65/73 patients). IIA patency at 180 days was 96.61% (57/59 patients). Sexual dysfunction occurred in one patient (1.69%), and two patients (3.39%) experienced buttock claudication. There was no mortality, type III endoleak, stent migration, kinking, or fracture during the procedure and follow-up. Conclusions The IBSG implantation system is a safe and effective technique for IIA preservation during AIA or CIAA endovascular repair. The high technical success rate, IIA patency rate, and low complication rate are promising. Follow-up will be continued for 5 years to confirm the durability of the device.