Comparison of small intestinal submucosa-covered and noncovered nitinol stents with PTFE endografts in injured ovine femoral arteries: a pilot study.

The purpose of this study was to compare performance of small intestinal submucosa (SIS)-covered endografts (SCEs) to polytetra-fluoroethylene (PTFE)-covered endografts (PCEs) and to bare nitinol stents (BSs) in injured sheep femoral artery (FA). Bare Zilver 6 mm X 40 mm nitinol stents (n = 6), Zilver stents covered with SIS (n = 6), and Palmaz stents 6 mm x 37 mm covered with PTFE (n = 6) were implanted in the balloon-injured FAs of nine female sheep. Follow-up arteriograms were obtained before animal sacrifice at 1, 3 and 6 months, with three animals at each time point. The FAs with the implanted device were explanted for histologic studies and morphologic measurements. Stent implantation was technically successful in all sheep. All BS and SCEs were patent at each time point. Five BSs and five SCEs exhibited formation of progressive eccentric intimal hyperplasia (IH) that was more advanced in SCE at 6 months. Cross-sectional area narrowing averaged 60% for BSs and 67% for SCEs. One BS, one SCE and two patent PCEs exhibited mild-to-moderate formation of concentric IH. Four PCS occluded one at 1 month, two at 3 months and one at 6 months. Performance of the devices placed into sheep FAs depended on their relation to the curving peri-articular portion of the FA during extremity flexion. BSs and SCEs placed in this portion exhibited progressive growth of eccentric IH while PCEs placed in this portion occluded.