ATHERO: Advanced Technology Halting Early Re-Stenosis and Occlusion

• Primary target patency at 12 months. The “target” is the index stenotic lesion(s). Primary patency is defined as <50% residual stenosis by duplex (color-flow Doppler) scan analysis, with antegrade flow to the target vessel.
  

• Ankle Brachial Index (ABI) improvement by ≥0.15 at 3, 6 and 12 months compared to baseline
  
• Change in Walking Impairment Questionnaire (WIQ) functional status scores from baseline at 3, 6 and 12 months
  
• Complications: defined as adverse events (AEs) or serious adverse events (SAEs). Complications may or may not be device related
  
• Cost to patient and hospital: Including operating room times and duration of hospitalization.
  

Peripheral arterial disease affects more than 12 million Americans, and its incidence is growing annually. The male/female ratio of patients with claudication is just under 2/1. The arteries involved by atherosclerosis involve the arteries to the thigh and leg. These include the femoral and popliteal arteries. Fifty percent of people with femoral-popliteal PVD are symptomatic. Symptoms are typically related to exertional fatigue of thigh and calf muscles. These symptoms, referred to as claudication, seldom represent a life or even limb-threatening process. They do, however, result in significantly decreased productivity and an often devastating quality of life.

Traditional interventions for lower extremity claudication include technologies invented in the first half of the 20th century including surgical bypass; and those invented in the second half of the twentieth century, including balloon angioplasty and stenting. These interventions have substantial shortcomings. It is, however, relevant to note that endovascular (aka endoluminal or endovascular surgery) is becoming increasingly popular and gaining wide-spread support from vascular interventionalist societies wordwide.

The main shortcomings of angioplasty and stenting is the resultant inflammatory response. The mechanical injury to blood vessels is followed by a complex repair response comprising intimal vascular smooth muscle cell (VSMC) hyperplasia, vessel wall scarring and shrinkage of the vascular lumen, often resulting in reduced blood flow and subsequent muscle (or end organ) ischemia. Rodent, rabbit and large animal models have provided valuable insights into the pathophysiology of these responses.

The devices utilized in this protocol are both FDA approved for the procedures described in the protocol. The devices include the Silverhawk™ System (FoxHollow Technologies, Redwood City, CA) and the PolarCath™ Peripheral Dilatation System, Boston Scientific, Natick, Massachusetts). Hereafter both products will be referred to as the “Devices.”