BIOTRONIK cobalt chromium balloon-expandable Dynetic-35 stent in association with Passeo-35 Xeo peripheral dilation catheter for the treatment of peripheral iliac lesions
Prospective, international, multi-center, single-arm study with up to 60 months follow up to evaluate safety and effectiveness of BIOTRONIK's Dynetic-35 stent associated with the use of Passeo-35 Xeo for the treatment of peripheral artery disease (PAD) in subjects with atherosclerotic disease in iliac arteries
Study Type
OBSERVATIONAL
Enrollment
160
Endovascular treatment for the peripheral artery disease of the Iliac artery
LKH Univ.-Klinikum Graz, Ambulanz für Angiologie
Graz, Austria
Zol Genk
Genk, Belgium
UZ Gent
Ghent, Belgium
MAE at 12 months post-index procedure.
The MAE includes device or procedure related death within 30 days post index procedure, cdTLR, and major index limb amputation up to 12 months post index procedure.
Time frame: 12 Months
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Regionaal Ziekenhuis Heilig Hart Tienen
Tienen, Belgium
Az Jan Potaels Vilvoorde
Vilvoorde, Belgium
Hôpital Privé du grand Narbonne
Narbonne, France
Hôpital Ambroise Paré
Paris, France
Klinikum Bayreuth
Bayreuth, Germany
Universitätsklinikum Essen
Essen, Germany
Diakonissenkrankenhaus
Flensburg, Germany
...and 5 more locations