Status:
COMPLETED
Local Paclitaxel Delivery for SFA Disease
Lead Sponsor:
University of Oklahoma
Conditions:
Atherosclerosis
Angioplasty
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
To see if restenosis rates of superficial femoral artery atherosclerosis with percutaneous techniques can be improved using paclitaxel.
Detailed Description
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 sugges...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00821028
Start Date
January 1 2009
End Date
April 1 2012
Last Update
August 17 2017
Active Locations (1)
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1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73126