A Randomized Trial Comparing the ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent for Treatment of Superficial Femoral and/or Proximal Popliteal Arteries
This trial will be comparing the Eluvia stent with the Zilver PTX stent in patients with chronic, symptomatic atherosclerosis of the lower extremities. The primary objective of this trial is to evaluate the safety and effectiveness of the ELUVIA Drug-Eluting Vascular Stent System.
Are you Eligible? (Inclusion Criteria)
Adult patients with chronic, symptomatic atherosclerosis in the lower extremities. Inclusion criteria include:
- Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4.
- Stenotic, restenotic or occlusive lesion(s) located in the native
SFA and/or PPA:
- Degree of stenosis 70% by visual angiographic assessment
- Vessel diameter ≥ 4 and 6 mm
- Total lesion length (or series of lesions) ≥ 30 mm and 140 mm (Note: Lesion segment(s) must be fully covered with one ELUVIA stent or up to
two Zilver PTX stents)
- For occlusive lesions requiring use of re-entry device, lesion
length ≤ 120 mm
- Target lesion located at least three centimeters above the
inferior edge of the femur
- Patent infrapopliteal and
popliteal artery, i.e., single vessel runoff or better with at least one
of three vessels patent (<50% stenosis) to the ankle or foot with no
Exclusion Criteria include:
- Previously stented target lesion/vessel.
- Target lesion/vessel previously treated with drug-coated balloon <12 months prior to randomization/enrollment.
- Subjects who have undergone prior surgery of the SFA/PPA in the target limb to treat atherosclerotic disease.
- Use of atherectomy, laser or other debulking devices in the target limb SFA/PPA during the index procedure.
- History of major amputation in the target limb.
- Documented life expectancy less than 24 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the clinical trial, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the clinical trial.