Reliable femoral chronic total occlusion model using a thin biodegradable polymer coated copper stent in a porcine model.

Chronic total occlusions (CTOs) are common in patients with peripheral arterial disease (PAD). This study aimed to examine the feasibility and reliability of a CTO induced by a thin biodegradable polymer (polyglycolic acid) coated copper stent in a porcine femoral artery. Novel thin biodegradable polymer coated copper stents (9 mm long) were crimped on an angioplasty balloon (4.5 mm diameter × 12 mm length) and inserted into the femoral artery. Histopathologic analysis was performed 35 days after stenting. In five of six stented femoral arteries, severe in-stent restenosis and total occlusion with collateral circulation were observed without adverse effects such as acute stent thrombosis, leg necrosis, or death at 5 weeks. Fibrous tissue deposition, small vascular channels, calcification, and inflammatory cells were observed in hematoxylin-eosin, Carstair's, and von Kossa tissue stains; these characteristics were similar to pathological findings associated with CTOs in humans. The neointima volume measured by micro-computed tomography was 93.9 ± 4.04 % in the stented femoral arteries. CTOs were reliably induced by novel thin biodegradable polymer coated copper stents in porcine femoral arteries. Successful induction of CTOs may provide a practical understanding of their formation and application of an interventional device for CTO treatment.