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KMID : 1103720200810040899
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Journal of the Korean Society of Radiology
2020 Volume.81 No. 4 p.899 ~ p.911
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Efficacy and Safety of a Newly Developed Self-Expanding Open-Cell Type Nitinol Stent for Peripheral Arteries: A Preclinical Study in Minipigs
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Kim Min-Uk
Lee Jae-Hwan
Yoon Chang-Jin
Choi Won-Seok
Hur Sae-Beom
Chung Jin-Wook
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Abstract
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Purpose: To evaluate the safety and efficacy of the newly designed open-cell type self-expandable nitinol stent (NiTi-stent) for peripheral arteries.
Materials and Methods: Twenty-eight limbs of 14 minipigs were randomly assigned to the NiTi-stent group or conventional nitinol stent group. Stents were symmetrically implanted into the iliac arteries of each animal using carotid artery approach and were observed for 1 month (n = 5) and 6 months (n = 9). The angiographic lumen diameter (ALD), late lumen loss, angiographic stenosis, histomorphometric lumen area, neointimal area, and area stenosis were analyzed and compared between the groups.
Results: Stent migration, stent fracture, or thrombus formation were not observed in either group. At the 1-month follow-up, the neointimal area (p = 0.008) and area stenosis (p = 0.016) were significantly smaller in the NiTi-stent group than in the control group. At the 6-months follow-up, the NiTi-stent group showed significantly larger ALD (p = 0.014), less late lumen loss (p = 0.019), less angiographic stenosis (p = 0.014), larger lumen area (p = 0.040), and smaller neointimal area and area stenosis (p = 0.004 and p = 0.014, respectively) compared with the control group.
Conclusion: The NiTi-stent is as safe and effective as the conventional nitinol stent and induces less neointimal hyperplasia in a minipig iliac artery model.
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KEYWORD
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Stents, Swine, Nitinol, Iliac Artery
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