Local Paclitaxel Delivery for SFA Disease

Treatment of Superficial Femoral Artery Atherosclerotic Disease With Local Delivery of Paclitaxel Using an Irrigating Catheter: a Single-center Pilot Study

To see if restenosis rates of superficial femoral artery atherosclerosis with percutaneous techniques can be improved using paclitaxel.

Treatment of superficial femoral artery atherosclerosis with percutaneous techniques is hindered by high restenosis rates. Paclitaxel inhibits restenosis in coronary arteries, and a few studies suggest it may be effective in reducing restenosis rates in peripheral arteries. The investigators hypothesize that delivering paclitaxel through an irrigating catheter will be superior in preventing restenosis.

Inclusion Criteria:

• All subjects between 18 and 80 years of age with symptomatic claudication (Rutherford category 1-6) with TASC II type A, B, or C lesions will be invited to participate (23, 24).
• Patients must be on appropriate pharmacologic therapy for PAD including antiplatelet agents and lipid-lowering therapy.

Exclusion Criteria:

• Life expectancy <1year
• Acute limb ischemia
• Anatomy not amenable to percutaneous revascularization
• Inability to provide informed consent
• Renal insufficiency (creatinine clearance <40mL/min calculated using Cockcroft-Gault equation)
• Prisoners
• Pregnant or lactating women