CompletedNot Applicable

Local Paclitaxel Delivery for SFA Disease

United States27 participantsStarted 2009-01

Plain-language summary

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

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Superficial femoral artery late lumen loss

Timeframe: 12 months

Trial details

NCT IDNCT00821028

SponsorUniversity of Oklahoma

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-12

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