Local Paclitaxel Delivery for SFA Disease

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oklahoma
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

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