Type 1 collagen as an endovascular stent-graft material for small-diameter vessels: A biocompatibility study

PURPOSE: To compare patency rates and degrees of neointimal hyperplasia between bovine type 1 collagen stent-grafts and uncovered control stents in small-diameter vessels (≤4 mm). MATERIALS AND METHODS: Uncovered stainless-steel, balloon-expandable stents (n = 5) and type 1 collagen stent-grafts (n = 6) were implanted via the femoral arteries with use of 4-mm balloon catheters into the abdominal aorta of New Zealand White rabbits. Ten animals were available for follow-up. Subjects were followed for 1 month (three uncovered stents; three collagen stent-grafts) or 4 months (two uncovered stents; two collagen stent-grafts). Angiography was performed before animal sacrifice and luminal compromise was compared between groups. Histologic and immunohistochemical analysis was performed to determine presence of neointima and neointimal thickness and area; these parameters were also compared between groups. RESULTS: All stents and stent-grafts remained patent at both time points. Luminal compromise was not detectable angiographically in any subject. Maximum neointimal thickness was less than 5 μm for all subjects. Neointimal thickness and area were not statistically significantly different between groups. CONCLUSIONS: Type 1 collagen stent-grafts demonstrate excellent hemocompatibility and biocompatibility in small-diameter vessels in rabbits.