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Background <p>This study aimed to evaluate the safety and effectiveness of the Kanshas drug-coated balloon (DCB) with paclitaxel for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery (PA) over a 3-year period.</p> Results <p>A prospective, multicenter, single-arm trial enrolled 121 patients with symptomatic lower extremity artery disease (LEAD). At 3&#xa0;years, the primary patency rate was 63.4%, and freedom from clinically driven target lesion revascularization (CD-TLR) was 83.2%. Sustained improvements were observed in Rutherford classification, ankle brachial index (ABI), and walking impairment questionnaire (WIQ) scores. No device- or procedure-related deaths or major amputations occurred.</p> Conclusions <p>The Kanshas DCB showed favorable safety and effectiveness for treating atherosclerotic lesions in the SFA and/or proximal PA over 3&#xa0;years.</p> Trail registration <p>Registration ID: UMIN000034122.&#xa0;Registration Date: September 13, 2018.&#xa0;Registration site URL: <a href="https://center6.umin.ac.jp/cgi-openbin/ctr/ctr.cgi?function=brows&amp;action=brows&amp;recptno=R000038612&amp;type=summary&amp;language=J">https://center6.umin.ac.jp/cgi-openbin/ctr/ctr.cgi?function=brows&amp;action=brows&amp;recptno=R000038612&amp;type=summary&amp;language=J</a>.</p> Graphical Abstract <p></p>

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Three-year outcomes of the TCD-17187 (Kanshas) drug-coated balloon for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery

  • 期刊论文

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  • 发表日期：

    2026年4月24日

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  • Shu-Ichi Seki,
  • Yoshimitsu Soga,
  • Osamu Iida,
  • Daizo Kawasaki,
  • Hitoshi Anzai,
  • Hiroshi Ando,
  • Tatsuya Nakama,
  • Norihiko Shinozaki,
  • Amane Kozuki,
  • Masaharu Ishihara,
  • Kazushi Urasawa,
  • Fumiyuki Hayashi,
  • Hiroaki Tsujita,
  • Kazuki Tobita,
  • Kenji Ogata,
  • Kazunori Horie,
  • Naoki Hayakawa,
  • Shinsuke Mori,
  • Masahiko Fujihara,
  • Takao Ohki,
  • Kenichiro Yuba,
  • Toshiaki Mano,
  • Masato Nakamura

摘要

Background

This study aimed to evaluate the safety and effectiveness of the Kanshas drug-coated balloon (DCB) with paclitaxel for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery (PA) over a 3-year period.

Results

A prospective, multicenter, single-arm trial enrolled 121 patients with symptomatic lower extremity artery disease (LEAD). At 3 years, the primary patency rate was 63.4%, and freedom from clinically driven target lesion revascularization (CD-TLR) was 83.2%. Sustained improvements were observed in Rutherford classification, ankle brachial index (ABI), and walking impairment questionnaire (WIQ) scores. No device- or procedure-related deaths or major amputations occurred.

Conclusions

The Kanshas DCB showed favorable safety and effectiveness for treating atherosclerotic lesions in the SFA and/or proximal PA over 3 years.

Trail registration

Registration ID: UMIN000034122. Registration Date: September 13, 2018. Registration site URL: https://center6.umin.ac.jp/cgi-openbin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000038612&type=summary&language=J.

Graphical Abstract