Long-Term Efficacy of Lutonix in a Real-World Femoropopliteal Patients With Peripheral Arterial Disease: Insights From the SAFE-DCB US Registry - Takeaways - MDSpire

Long-Term Efficacy of Lutonix in a Real-World Femoropopliteal Patients With Peripheral Arterial Disease: Insights From the SAFE-DCB US Registry

  • By

  • Nicolas W. Shammas

  • Dion Franga

  • Erin Moore

  • George Mueller

  • Thomas P. Davis

  • Edward Woo

  • Investigators of SAFE-DCB US Registry

  • June 29, 2026

  • 0 min

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  • 1

    The Lutonix SAFE-DCB US Registry is the largest prospective multicenter study evaluating the Lutonix DCB in real-world patients.

  • 2

    The study included patients with stenotic or obstructive lesions in the superficial femoral artery and/or popliteal artery.

  • 3

    Primary effectiveness was measured by freedom from target lesion revascularization at 12 months post-procedure.

  • 4

    Primary safety endpoints included perioperative death, major amputation, and target vessel revascularization within 30 days.

  • 5

    The study aimed to address the evidence gap between randomized controlled trial data and long-term clinical performance.

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