新闻资讯
科思
/
/
/
Evaluation of the Biodegradable Peripheral Igaki-Tamai Stent in the Treatment

Evaluation of the Biodegradable Peripheral Igaki-Tamai Stent in the Treatment

  • 分类:学术论文
  • 作者:
  • 来源:
  • 发布时间:2016-08-12 09:22
  • 访问量:

【概要描述】This study sought to evaluate the safety and performance of the Igaki-Tamai (Igaki Medical Planning Company, Kyoto, Janpan) biodegradable stent in patients with occlusive superficial femoral artery (SFA) disease.

Evaluation of the Biodegradable Peripheral Igaki-Tamai Stent in the Treatment

【概要描述】This study sought to evaluate the safety and performance of the Igaki-Tamai (Igaki Medical Planning Company, Kyoto, Janpan) biodegradable stent in patients with occlusive superficial femoral artery (SFA) disease.

  • 分类:学术论文
  • 作者:
  • 来源:
  • 发布时间:2016-08-12 09:22
  • 访问量:
详情

  OBJECTIVES: This study sought to evaluate the safety and performance of the Igaki-Tamai (Igaki Medical Planning Company, Kyoto, Janpan) biodegradable stent in patients with occlusive superficial femoral artery (SFA) disease.

  BACKGROUND: Poly-L-lactic acid (PLLA) biodegradable stents have been shown to be effective in the coronaries, but no data are available regarding their efficacy in the femoral artery.

  METHODS: A prospective, multicenter, nonrandomized study enrolled 30 patients with symptomatic de-nonv SFA diease undergoing implantation of Igaki-Tamai bioresorbable stents. Clinical examinations and duplex ultrasound were prospectively performed after 1, 6, 9, and 12 months. The main study endpoints were technical success, restenosis rate, rate of target lesion revascularization (TLR), changes in ankle-brachial index (ABI), and quality of life by evaluating the walking impairment questionnaire (WIQ). Safety was assessed by monitoring the occurrence of major adverse clinical events and serious adverse events.

  RESULTS: The mean age of the patients was 67.7 years, and 77% were male. The mean lesion length was 5.9 cm. Mean diameter stenosis was reduced from 89.9% to 6.2%, after stent implantation. Technical success was 96.7%. Binary restenosis rate for the 6 and 12 months follow-up was 39.3% and 67.9%, respectively. The TLR rate was 25.0% after 6 months and 57.1% after 12 months. All TLR were successful; the secondary patency rate after 1 year was 89.3%. Between baseline and 12 months, ABI increased in 53.6% of patients. Functional endpoints (WIQ), even if affected by a relatively high reintervention rate, showed improvement in most of the patients.

  CONCLUSIONS: The GAIA ( Evaluation of the Biodegradable Peripheral Igaki-Tamai Stent in the Treatment of De Novo Lesions in the SuperficialFemoral Artery) study shows that when using biodegradable PLLA stents (Igaki-Tamai), the immediate angiographic results are comparable to the results of metal stents, achieving a high secondary patency rate after 1 year. Modifications of stent characteristics and technical modifications are needed with the goal to reduce the restenosis rate during the reabsorption period.

北京阿迈特公司又一项美国专利获授权
2023 03-16

北京阿迈特公司又一项美国专利获授权

中国生物材料学会材料生物力学分会换届大会圆满召开
2022 12-08

中国生物材料学会材料生物力学分会换届大会圆满召开

精准植入 完美心舒——冠脉支架定位系统
2022 11-27

精准植入 完美心舒——冠脉支架定位系统

公司信息

北京阿迈特医疗器械有限公司

Beijing Advanced Medical Technologies,Ltd.Inc.

联系我们

地址:北京市大兴区永旺西路26号院中关村医疗器械园11号楼

电话:010-6297-7955             邮箱:amt@ametcorp.com

联系我们

地址:北京市大兴区永旺西路26号院中关村医疗器械园11号楼

电话:010-6297-7955             

邮箱:amt@ametcorp.com