Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Brodmann, M; Nemes, B; Moreels, N; Austermann, M; Schmehl, J; Robijn, J; Rammos, C; Müller-Hülsbeck, S; Keirse, K; Coscas, R; Kupcs, K; Augustin, AM; Moebius-Winkler, S; Lichtenberg, M; Lansink, W.
Dynetic-35 cobalt chromium balloon-expandable stent for iliac lesions: 12-month results of the BIONETIC-I multi-center study
CVIR ENDOVASC. 2025; 8(1): 114
Doi: 10.1186/s42155-025-00633-z
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- Führende Autor*innen der Med Uni Graz
- Brodmann Marianne
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- Abstract:
- 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 revasculari- zation (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 con- fidence 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 classifica- tion, 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.
- Find related publications in this database (Keywords)
- Peripheral artery disease (PAD)
- Iliac artery stenting
- Cobalt chromium stent
- Endovascular treatment
- Atherosclerotic lesions