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Purpose <p>The BIONETIC-I trial aimed to evaluate the safety and effectiveness of the cobalt chromium Dynetic-35 stent, used in conjunction with the Passeo-35 Xeo peripheral dilation catheter, for treating atherosclerotic lesions in iliac arteries of patients with peripheral artery disease (PAD).</p> Materials and methods <p>This international, multi-center, prospective, single-arm study enrolled 160 subjects with 212 lesions across six European countries. The primary endpoint was a composite of major adverse events (MAE) at 12&#xa0;months, including device- or procedure-related death within 30&#xa0;days, clinically driven target lesion revascularization (cdTLR), and major index limb amputation. Secondary endpoints included technical and procedural success, cdTLR rate, mortality, major amputation rate, primary patency, and changes in PAD-related parameters.</p> Results <p>The patients (61.9% male, median age 65&#xa0;years) presented with predominantly calcified lesions (90.1%) and high-grade stenosis (average 85.5%), with 12.5% having CLTI. The 12-month MAE rate was 3.5% (97.5% upper confidence limit: 7.2%), significantly non-inferior to the pre-specified performance goal (<i>p</i> &lt; 0.0001). Secondary endpoints showed favorable 12-month outcomes, including a low cdTLR rate (2.0%), robust core lab-reported primary patency (93.1%), and significant improvements in PAD-related parameters such as Ankle-Brachial Index, Rutherford classification, and Walking Impairment Questionnaire. Subgroup analysis revealed no differences in MAEs between patients with severe/moderate and mild/no calcification, with notable improvements in functional measures for those with severe/moderate calcification.</p> Conclusion <p>The balloon-expandable cobalt chromium stent Dynetic-35 demonstrated safety and effectiveness in treating iliac arteries at the 12-month timepoint, showing promising results across various patient subgroups, including those with calcified lesions.</p> Level of evidence <p>Level 2, therapeutic study.</p> Trial registration <p>ClinicalTrials.gov, NCT04830228. Registered 31 March 2021, <a href="https://clinicaltrials.gov/ct2/show/NCT04830228">https://clinicaltrials.gov/ct2/show/NCT04830228</a>.</p>

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Dynetic-35 cobalt chromium balloon-expandable stent for iliac lesions: 12-month results of the BIONETIC-I multi-center study

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  • 出版模式：

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  • 发表日期：

    2025年12月13日

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  • Marianne Brodmann,
  • Balázs Nemes,
  • Nathalie Moreels,
  • Martin Austermann,
  • Jörg Schmehl,
  • Jorn Robijn,
  • Christos Rammos,
  • Stefan Müller-Hülsbeck,
  • Koen Keirse,
  • Raphael Coscas,
  • Karlis Kupcs,
  • Anne Marie Augustin,
  • Sven Moebius-Winkler,
  • Michael Lichtenberg,
  • Wouter Lansink

摘要

Purpose

The BIONETIC-I trial aimed to evaluate the safety and effectiveness of the cobalt chromium Dynetic-35 stent, used in conjunction with the Passeo-35 Xeo peripheral dilation catheter, for treating atherosclerotic lesions in iliac arteries of patients with peripheral artery disease (PAD).

Materials and methods

This international, multi-center, prospective, single-arm study enrolled 160 subjects with 212 lesions across six European countries. The primary endpoint was a composite of major adverse events (MAE) at 12 months, including device- or procedure-related death within 30 days, clinically driven target lesion revascularization (cdTLR), and major index limb amputation. Secondary endpoints included technical and procedural success, cdTLR rate, mortality, major amputation rate, primary patency, and changes in PAD-related parameters.

Results

The patients (61.9% male, median age 65 years) presented with predominantly calcified lesions (90.1%) and high-grade stenosis (average 85.5%), with 12.5% having CLTI. The 12-month MAE rate was 3.5% (97.5% upper confidence limit: 7.2%), significantly non-inferior to the pre-specified performance goal (p < 0.0001). Secondary endpoints showed favorable 12-month outcomes, including a low cdTLR rate (2.0%), robust core lab-reported primary patency (93.1%), and significant improvements in PAD-related parameters such as Ankle-Brachial Index, Rutherford classification, and Walking Impairment Questionnaire. Subgroup analysis revealed no differences in MAEs between patients with severe/moderate and mild/no calcification, with notable improvements in functional measures for those with severe/moderate calcification.

Conclusion

The balloon-expandable cobalt chromium stent Dynetic-35 demonstrated safety and effectiveness in treating iliac arteries at the 12-month timepoint, showing promising results across various patient subgroups, including those with calcified lesions.

Level of evidence

Level 2, therapeutic study.

Trial registration

ClinicalTrials.gov, NCT04830228. Registered 31 March 2021, https://clinicaltrials.gov/ct2/show/NCT04830228.