Novel stent system for accurate placement in aorto-ostial renal artery disease: preclinical study in porcine renal artery model☆

Abstract 

Background

Treatment of aorto-ostial renal artery stenosis has been associated with a lower procedural success and higher complication and restenosis rate, as compared to nonostial lesions. The design and delivery of currently available stent systems in ostial lesions can result in inaccurate stent positioning and placement leading to stent protrusion into the parent vessel lumen or geographic miss. A novel stent system (SquareOne Inc., Campbell, CA, USA) has been designed specifically for aorto-ostial lesions in the renal artery. This stent system aims to provide both tactile and visual confirmation of the ostium at the aorta, allow for improved accuracy during stent positioning and placement, provide complete scaffolding of the lesion at the aortic junction to the native vessel, and enable future vessel reaccess.

Methods

Stents (n=12) were implanted in both renal arteries of six swine. For histology, two animals were euthanized immediately after stent implantation, and each two animals were then followed up at 2 and 4 weeks, respectively. Intravascular ultrasound (IVUS) studies were performed immediately after stent implantation and at follow-up.

Results

Proper stent positioning and implantation was obtained in all animals. Angiographic and IVUS assessments indicated no dissection or thrombus formation. Histology demonstrated good apposition and endothelialization of the stent strut surface.

Conclusion

The unique flared shape of this novel ostial stent system allows for improved accuracy during stent positioning and placement, as well as complete apposition and coverage/scaffolding of the similarly-shaped luminal ostium. Future studies will determine if this novel stent system fulfills the unmet clinical need in aorto-ostial stenoses.

Keywords: Renal artery stenosis, Aorto-ostial stent