Drug Eluting Stent for the Management of PERipheral Arterial Disease Of the SFA (DESPERADO-SFA Study)

• Patient with lower extremity claudication and Peripheral Arterial Disease (PAD) due to significant SFA stenosis (60%≤99%) or total occlusions (100%) that affects the quality of life despite medical therapy.

• Evidence of significant SFA disease involving the most symptomatic limb by noninvasive vascular testing with the use of the following:

  • ABI: \<0.9 (If ABI>1.4, SFA systolic acceleration time should be > 140 milliseconds);
  • TBI: \<0.6;
  • Computed Tomographic Angiography (CTA) confirming at least a 60% SFA stenosis; or
  • Magnetic Resonance Angiography (MRA) confirming at least a 60% SFA stenosis
• At least one patent, non-treated below the knee vessel.
• Male and female patients that are ≥ 18 years of age.
• Subject has been advised of the beneficial effects of smoking cessation and regular exercise but must not be in the process of changing their smoking status at the time of screening. Patients may resume or increase exercising as an effect of post procedurally improved lower limb perfusion.
• Peak Walking Time (PWT) limited only by claudication.
• Willingness to participate in the study, documented by signed, written informed consent.

Exclusion Criteria:

• Planned usage of atherectomy devices during procedure. The following devices are the only permitted devices that can be used for intervention procedures:

  • Conventional balloons
  • Zilver PTXTM stent
• Planned amputation.
• Any planned/scheduled revascularization procedures ≤ 30 days after baseline procedure.
• Prior lower extremity revascularization ≤ 30 days before baseline procedure.
• The target lesion is an in-stent restenosis.
• Infra-popliteal disease involving the last remaining vessel.
• Patients with a creatinine clearance \< 30mL/min.
• Patients with known bleeding disorders.
• Patients with known active pathological bleeding.
• Patients with known hypersensitivity to acetylsalicylic acid, clopidogrel bisulfate, ticagrelor, Aspirin, or other antiplatelets/anticoagulants.
• Patients with known history of intracranial hemorrhage at any time, GI bleed in the past 6 months, or major surgery within the past 30 days.
• Patients with known ischemic stroke during the past 3 months.
• Patients with known severe liver disease.
• Patient with known history of congestive heart failure (CHF) with an LVEF of \< 30%.
• Patients considered being at risk of bradycardic events unless treated with a permanent pacemaker.
• Female patients with known pregnancy, breast feeding, or intend to become pregnant during the study period (all female patients 55 years and younger, without a history of hysterectomy must have a pregnancy test prior to PPI at baseline and at 12 months).
• Concern for inability of the patient to comply with study procedures and/or follow up (e.g., alcohol or drug abuse).