To determine whether the Boston Scientific nitinol drug-eluting stent shows acceptable performance at 9 months when treating Superficial Femoral (SFA) and/or Proximal Popliteal Artery (PPA) lesions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Drug-eluting SFA self-expanding stent
Royal Prince Alfred Hospital
Camperdown, Australia
Prince of Wales Hospital
Randwick, Australia
Allgemeines Krankenhaus AKH
Vienna, Austria, Austria
Primary Patency
Primary patency of target lesion at 9-months assessed by duplex ultrasound (DUS) as adjudicated by an independent core laboratory. Primary Patency: percentage (%) of lesions (target stented segments) that reach endpoint without a hemodynamically significant stenosis on DUS and without target lesion revascularization (TLR) or, bypass of the target lesion.
Time frame: 9-months
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AZ Sint-Blasius
Dendermonde, Belgium
Ziekenhuis Oost Limburg
Genk, Belgium
Regionaal Ziekenhuis Heilig Hart Tienen
Tienen, Belgium
Universitäts-Herzzentrum Freiburg Bad Krozingen GmbH
Bad Krozingen, Germany
Ev. Luth. Diakonissenanstalt Flensburg
Flensburg, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Universität Leipzig
Leipzig, Germany
...and 3 more locations