A Belgian physician-initiated trial investigating the LifeStream peripheral stent graft system for the treatment of complex TASC C and D iliac lesions.

BACKGROUND

Due to the heterogeneity of literature findings, stent type selection for the endovascular treatment of complex aorto-iliac occlusive disease remains challenging. The BELSTREAM study, a physician-initiated, prospective, multicenter, single-arm study, aims to report the safety and efficacy of the balloon expandable LifeStream Peripheral Stent Graft System (BD, Tempe, Arizona, USA) for the treatment of complex TASC C and D aorto-iliac artery lesions.

METHODS

Seventy patients and 133 lesions were included at six Belgian institutions. The primary efficacy endpoint of the study is primary patency at 12 months' follow-up. The primary safety endpoint is freedom from periprocedural serious adverse events (SAEs).

RESULTS

Primary patency rate at 12-month follow-up was 94.5%. Target Lesion Revascularization (TLR) was reported in three patients at 12-month follow-up, resulting in a freedom from TLR rate of 95.3%. In a subgroup of patients with aorto-iliac stenting in kissing configuration, primary patency at 12-month follow-up was 97.4% with freedom from TLR 97.9%. Freedom from a negative primary safety outcome (NPSO) was 100% at 30 days in the overall study patient population.

CONCLUSIONS

The patency and freedom from TLR rates, low adverse event rates, and up to one year sustained improvement in clinical outcomes demonstrate that the LifeStream™ Balloon Expandable Vascular Covered Stent is a well-suited device for the treatment of complex TASC C and D lesions, the challenging kissing configuration included.