Patients with peripheral artery disease will be treated with either drug coated balloon catheter, drug coated stent or uncoated stent.
Patients with chronic stenotic or occlusive atherosclerotic disease and lesions of at least 13 cm length in the SFA or Arteria poplitea segment 1 will be randomized to either treatment with paclitaxel coated balloon catheter, paclitaxel coated stent or bare nitinol stent. Vessel patency will be evaluated by quantitative angiography after 12 months. Clinical follow-ups will be done until 36 months post-intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
224
Dilatation of occluded or highly stenosed vessel with paclitaxel-coated balloon catheter
Dilatation of occluded or highly stenosed vessel with paclitaxel-coated stent
Dilatation of occluded or highly stenosed vessel with uncoated bare nitinol stent
Medizinische Universität Graz
Graz, Austria
RoMed Klinikum
Rosenheim, Bavaria, Germany
Klinikum Arnsberg, Karolinen-Hospital
Arnsberg, Germany
Herzzentrum Bad Krozingen
Bad Krozingen, Germany
Percent diameter stenosis at 1 year post intervention in successfully treated patients
by quantitative angiography
Time frame: 12 +/- 2 months
Late Lumen Loss
by quantitative angiography
Time frame: 12 months
Binary restenosis
by DUS
Time frame: 6,12, 24, 36 months
Target lesion revascularization
number of re-interventions at target lesion
Time frame: 6, 12, 24, 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ihre-Radiologen Standort Franziskus-Krankenhaus
Berlin, Germany
Ihre-Radiologen Standort Jüdisches Krankenhaus
Berlin, Germany
Vivantes Klinikum Neukölln
Berlin, Germany
Diakonissenkrankenhaus Flensburg
Flensburg, Germany
SANA Kliniken Lübeck
Lübeck, Germany
Universitätklinikum Lübeck
Lübeck, Germany