4EVER

4EVER

NCT01413139

Physician-initiated trial investigating the safety of the full 4F endovascular treatment approach of infra-inguinal arterial stenotic disease.1

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Conclusion

  • Pulsar stents are safe and effective for treating SFA disease with excellent performance and clinical outcomes: Primary patency (PP) and Freedom from Target Lesion Revascularization (FTLR) in line with other documented bare metal/passive coated stents in lesions with similar characteristics; PP in line with Zilver PTX (Drug-eluting stent) even though longer average lesion length in 4EVER study; Sufficient chronic outward force and compression resistance demonstrated by the favorable 24-month PP, even in calcified lesions and occlusions.
  • Astron Pulsar and Pulsar stents are safe and effective for treating SFA disease.
  • Clinical outcomes in line with other documented studies including Zilver PTX.
  • Sufficient radial force and compression resistance.

Patient Demographics and Lesion Characteristics

Picture shows patient demographics
Picture shows lesion characteristics

Study Design

  • Number of patients (n): 120
  • Primary Investigator: Dr. M Bosiers, A.Z. Sint-Blasius, Dendermonde, Belgium
  • Primary endpoint: Primary Patency (PP) at 12 months3
  • Secondary endpoints: PP at 6 and 24 months; freedom from Target Lesion Revascularization (FTLR) at 6, 12 and 24 months; technical success; puncture site complication rate; stent fracture rate at 12 and 24 motnhs; clinical success at 6, 12 and 24 months
  • Follow-up2: 6, 12 and 24 months
  • BIOTRONIK devices: Fortress, Astron Pulsar, Pulsar-18
  • Participating centers: Dr. P Peeters, Bonheiden, Belgiumn P.I. Dr. O d‘Archambeau, Antwerp, Belgiumn P.I. Prof. D Scheinert, Leipzig, Germanyn P.I. Prof. G Torsello, Münster, Germany

Results

12-month fracture rates in perspective

Picture shows Fracture Rates
Picture shows results
Picture shows results

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4EVER Clinical Study Flyer
BIOTRONIK 4 F system Passeo-18

Vascular Intervention

Pulsar-18

Self-expanding StentOne-handed stent release for accurate stent deployment

Picture shows Pulsar-35

Vascular Intervention

Pulsar-35

Self-expanding StentTri-axial shaft for a stable delivery system during stent deployment

Sources:
1 Bosiers M, Deloose K, Callaert J, et al. 4-French–compatible endovascular material is safe and effective in the treatment of femoropopliteal occlusive disease: results of the 4-EVER trial. J Endovasc Ther. 2013; 20: 746–756.
2 If patients received both, an Astron Pulsar and Pulsar stent.
3 PSVR < 2.5 by Duplex Ultrasound.
4 Durability II, Supera, Stroll, Zilver PTX.

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