The endovascular therapy prevailed in nearly all regions of peripheral artery disease over open surgery techniques. However, in treatment of the common femoral artery vascular surgery is still the gold standard of therapy. One-year patency rates are between 90% and 95%. Today, only in selected cases an endovascular procedure for common femoral artery diseases is recommended. The primary objective of this study is to compare the performance of directional atherectomy and drug-coated balloon angioplasty over vascular surgery in common femoral artery lesions in a prospective, multi-center, randomized clinical trial.
Multicenter, prospective, randomized study to be conducted in centers in Europe. A total of 260 subjects will be entered into the study and will be randomized on a 1:1 basis to either directional atherectomy and drug coated balloon angioplasty (optional with stentimplantation), and surgical endarterectomy for treatment in symptomatic (Rutherford-Becker class 2 to 4) common femoral artery disease. All subjects will undergo repeat duplex-ultrasound measurements 6, 12, and 24 months to assess the primary endpoint of Binary Restenosis. Follow-up visits are scheduled 6, 12, and 24 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
306
Directional atherectomy and paclitaxel-coated balloon angioplasty (optional with stentimplantation) of the common femoral artery
open, surgical endarterectomy of the common femoral artery
Universitäts-Herzzentrum Freiburg - Bad Krozingen
Bad Krozingen, Germany
RECRUITINGPrimary patency
Primary patency of the common femoral artery defined as freedom from target lesion restenosis (luminal narrowing of ≥50%) detected with duplex-ultrasound. The definition of a 50% restenosis is based on the peak systolic velocity ratio \>2.4.
Time frame: 12 month
Primary patency
Primary patency of the common femoral artery defined as freedom from target lesion restenosis (luminal narrowing of ≥50%) detected with duplex-ultrasound. The definition of a 50% restenosis is based on the peak systolic velocity ratio \>2.4.
Time frame: 24 month
target lesion revascularisation
Need for target lesion revascularisation after index procedure
Time frame: 6, 12, and 24 month
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