The registry will enroll patients with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects will be treated with the LUTONIX Drug Coated PTA Dilatation Catheter carrying the CE Mark per current Instructions for Use(IFU) and followed clinically for a minimum of 2 years.
Study Type
OBSERVATIONAL
Enrollment
691
Subject will receive treatment with the Lutonix Drug Coated Balloon
Allgemeines Krankenhaus Wien
Vienna, Austria
ZNA Campus Middelheim
Antwerp, Belgium
Freedom from Target Lesion Revascularization (TLR)
Efficacy: Freedom from TLR at 12 months.
Time frame: 12 months
Freedom from Target Vessel Revascularization(TVR), major index limb amputation, and device- and procedure-related death
Safety: Freedom at 30 days from TVR, major index limb amputation, and device- and procedure-related death
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CHU Le Bocage
Dijon, France
Karolinen Hospital Huesten
Arnsberg, Germany
Diakoniewerk Muenchen
München, Germany
Medinos Kliniken Sonneberg
Sonneberg, Germany
Kreiskrankenhaus Viechtach
Viechtach, Germany
Klinikum Weiden
Weiden, Germany
University General Hospital of Patras
Pátrai, Greece
AO Cardinal Massaia
Asti, Italy
...and 13 more locations