Efficacy and Safety of a Newly Developed Self- Expanding Open-Cell Type Nitinol Stent for Peripheral Arteries: A Preclinical Study in Minipigs

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 NiTistent group or conventional nitinol stent group. Stents we...

Full description

Bibliographic Details
Main Authors: Min Uk Kim, Jae Hwan Lee, Chang Jin Yoon, Won Seok Choi, Saebeom Hur, Jin Wook Chung
Format: Article
Language:English
Published: The Korean Society of Radiology 2020-07-01
Series:대한영상의학회지
Subjects:
Online Access:https://doi.org/10.3348/jksr.2020.81.4.899
_version_ 1818293392650534912
author Min Uk Kim
Jae Hwan Lee
Chang Jin Yoon
Won Seok Choi
Saebeom Hur
Jin Wook Chung
author_facet Min Uk Kim
Jae Hwan Lee
Chang Jin Yoon
Won Seok Choi
Saebeom Hur
Jin Wook Chung
author_sort Min Uk Kim
collection DOAJ
description 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 NiTistent 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 followup, 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.
first_indexed 2024-12-13T03:15:08Z
format Article
id doaj.art-a7730c2bc361421b99451ddc8e05bd28
institution Directory Open Access Journal
issn 1738-2637
2288-2928
language English
last_indexed 2024-12-13T03:15:08Z
publishDate 2020-07-01
publisher The Korean Society of Radiology
record_format Article
series 대한영상의학회지
spelling doaj.art-a7730c2bc361421b99451ddc8e05bd282022-12-22T00:01:30ZengThe Korean Society of Radiology대한영상의학회지1738-26372288-29282020-07-01814899911https://doi.org/10.3348/jksr.2020.81.4.899Efficacy and Safety of a Newly Developed Self- Expanding Open-Cell Type Nitinol Stent for Peripheral Arteries: A Preclinical Study in MinipigsMin Uk Kim0Jae Hwan Lee1Chang Jin Yoon2Won Seok Choi3Saebeom Hur4Jin Wook Chung5Department of Radiology, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, KoreaDepartment of Radiology, Seoul National University Bundang Hospital, Seongnam, KoreaDepartment of Radiology, Seoul National University Bundang Hospital, Seongnam, KoreaDepartment of Radiology, Seoul National University Bundang Hospital, Seongnam, KoreaDepartment of Radiology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, KoreaDepartment of Radiology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, KoreaPurpose 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 NiTistent 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 followup, 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.https://doi.org/10.3348/jksr.2020.81.4.899stentsswinenitinoliliac artery
spellingShingle Min Uk Kim
Jae Hwan Lee
Chang Jin Yoon
Won Seok Choi
Saebeom Hur
Jin Wook Chung
Efficacy and Safety of a Newly Developed Self- Expanding Open-Cell Type Nitinol Stent for Peripheral Arteries: A Preclinical Study in Minipigs
대한영상의학회지
stents
swine
nitinol
iliac artery
title Efficacy and Safety of a Newly Developed Self- Expanding Open-Cell Type Nitinol Stent for Peripheral Arteries: A Preclinical Study in Minipigs
title_full Efficacy and Safety of a Newly Developed Self- Expanding Open-Cell Type Nitinol Stent for Peripheral Arteries: A Preclinical Study in Minipigs
title_fullStr Efficacy and Safety of a Newly Developed Self- Expanding Open-Cell Type Nitinol Stent for Peripheral Arteries: A Preclinical Study in Minipigs
title_full_unstemmed Efficacy and Safety of a Newly Developed Self- Expanding Open-Cell Type Nitinol Stent for Peripheral Arteries: A Preclinical Study in Minipigs
title_short Efficacy and Safety of a Newly Developed Self- Expanding Open-Cell Type Nitinol Stent for Peripheral Arteries: A Preclinical Study in Minipigs
title_sort efficacy and safety of a newly developed self expanding open cell type nitinol stent for peripheral arteries a preclinical study in minipigs
topic stents
swine
nitinol
iliac artery
url https://doi.org/10.3348/jksr.2020.81.4.899
work_keys_str_mv AT minukkim efficacyandsafetyofanewlydevelopedselfexpandingopencelltypenitinolstentforperipheralarteriesapreclinicalstudyinminipigs
AT jaehwanlee efficacyandsafetyofanewlydevelopedselfexpandingopencelltypenitinolstentforperipheralarteriesapreclinicalstudyinminipigs
AT changjinyoon efficacyandsafetyofanewlydevelopedselfexpandingopencelltypenitinolstentforperipheralarteriesapreclinicalstudyinminipigs
AT wonseokchoi efficacyandsafetyofanewlydevelopedselfexpandingopencelltypenitinolstentforperipheralarteriesapreclinicalstudyinminipigs
AT saebeomhur efficacyandsafetyofanewlydevelopedselfexpandingopencelltypenitinolstentforperipheralarteriesapreclinicalstudyinminipigs
AT jinwookchung efficacyandsafetyofanewlydevelopedselfexpandingopencelltypenitinolstentforperipheralarteriesapreclinicalstudyinminipigs