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Three-Year Clinical Outcomes of the Innova™ Self-Expanding Nitinol Stent for the Treatment of Femoropopliteal Lesions

Abstract

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.

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Acknowledgments

The authors acknowledge the expertise of Masahiko Fujihara of Kishiwada Tokushukai Hospital, Daizo Kawasaki of Morinomiya Hospital, and Osamu Iida of Kansai Rosai Hospital as the steering committee. The authors also acknowledge the expertise of Seiichi Hiramori of Kokura Memorial Hospital, Shinsuke Mouri of Saiseikai Yokohama City Eastern Hospital, Kazushi Urasawa of Tokeidai Memorial Hospital, Taketsugu Tsuchiya of Kanazawa Medical University Hospital, Toru Mazaki of Kobe Central Hospital, Kimihiro Osaka of Kawakita General Hospital, Tatsuki Doijiri of Yamato Seiwa Hospital, Takashi Miura of Shinshu University School of Medicine, Masahito Taniguchi of Fukuyama Cardiovascular Hospital, Tai Kojima of Gifu University Graduate School of Medicine, Jun Nakazato of Okinawa Chubu Hospital, Hideki Aihara of Tsukuba Medical Center Hospital, Masahiko Noguchi of Tokyo Bay Urayasu Ichikawa Medical Center, Yohei Kobayashi of Osaka red Cross Hospital, Masanori Teramura of Ichinomiya Nishi Hospital, Kei Ichihashi of Ichinomiya Nishi Hospital, and Naoki Hayakawa of Asahi General Hospital in performing the catheterization procedures and data collection. We would like to thank Editage (www.editage.jp) for English language editing.

Funding

This study was not supported by any funding.

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Authors

Contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Mitsuyoshi Takahara, and Yoshimitsu Soga. The first draft of the manuscript was written by Eiji Karashima and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Eiji Karashima.

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Conflict of interests

The authors declare that they have no conflict of interest.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed Consent

Following the Ethical Guidelines for Medical and Health Research Involving Human Subjects in Japan, as the present study was performed with the secondary use of secondary data from medical records, it was exempted from the requirement of informed consent. The relevant information regarding this study was openly disclosed to the public.

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Karashima, E., Takahara, M., Hozawa, K. et al. Three-Year Clinical Outcomes of the Innova™ Self-Expanding Nitinol Stent for the Treatment of Femoropopliteal Lesions. Cardiovasc Intervent Radiol (2021). https://doi.org/10.1007/s00270-021-02960-9

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Keywords

  • Endovascular therapy
  • Innova
  • Self-expanding stent
  • Peripheral artery disease
  • Superficial femoral artery