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

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; Lifetech Scientific, Shenzhen, China) system for revascularization of the IIA.

Methods

Patients who underwent implantation of the IBSG at 8 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 end point was the IIA patency rate of the IBSG device at 180 days postoperatively. Secondary end points 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 end-point analysis. AIA was present in 55 patients (75.34%) and CIAA in 18 patients (24.66%). The iliac artery aneurysms were unilateral in 69 patients (94.52%) and bilateral in 4 patients (5.48%). Overall technical success was 89.04% (65 of 73 patients). IIA patency at 180 days was 96.61% (57 of 59 patients). Sexual dysfunction occurred in 1 patient (1.69%), and 2 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.