Purpose

To report the 3-year results of Innova™ stent implantation for the treatment of femoropopliteal (FP) lesions in a real-world setting.

Methods

This single-arm, retrospective, multicenter clinical study analyzed 481 lesions from 453 consecutive patients with symptomatic peripheral artery diseases (Rutherford category 1–6) who underwent endovascular therapy with implantation of Innova™ self-expanding nitinol stent for FP lesions. The primary outcome measure was the 3-year restenosis rate based on doppler-ultrasound or angiographic criteria. The secondary outcome measures included the rates of 3-year major amputation and major adverse limb events.

Results

Restenosis following Innova™ implantation was found in 61% of the cases at 3 years. At the end of 3 years, the rates of major amputations and major adverse limb events were 3 and 31%, respectively. In cases free from restenosis at 1 year, no predictive factors for restenosis at 3 years could be determined.

Conclusion

The present study demonstrated mid-term clinical outcomes after Innova™ stent implantation for the treatment of FP lesions in a real-world population. The Innova™ stent demonstrated acceptable clinical outcomes in a real-world setting.

中文翻译：

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Innova™ 自膨式镍钛诺支架治疗股腘病变的三年临床结果

目的

报告 Innova™ 支架植入术在真实环境中治疗股腘 (FP) 病变的 3 年结果。

方法

这项单臂、回顾性、多中心临床研究分析了 453 名有症状的外周动脉疾病（卢瑟福 1-6 级）患者的 481 处病变，这些患者接受了血管内治疗并植入 Innova™ 自膨式镍钛诺支架治疗 FP 病变。主要结局指标是基于多普勒超声或血管造影标准的 3 年再狭窄率。次要结局指标包括 3 年大截肢率和主要不良肢体事件的发生率。

结果

61% 的病例在 3 年时发现 Innova™ 植入后的再狭窄。3 年末，大截肢和主要不良肢体事件的发生率分别为 3% 和 31%。在 1 年没有再狭窄的情况下，无法确定 3 年再狭窄的预测因素。

结论

本研究展示了 Innova™ 支架植入治疗真实世界人群 FP 病变后的中期临床结果。Innova™ 支架在现实环境中表现出可接受的临床结果。