Local Paclitaxel Delivery for SFA Disease

University of Oklahoma27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atherosclerosis Angioplasty Peripheral Arterial Disease

Interventions

PaclitaxelDRUG

Paclitaxel will be administered intra-arterially through an irrigating catheter to treat a diseased segment of superficial femoral artery. Dosing will be based on ther lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm\^3

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

Superficial femoral artery late lumen loss

Time frame: 12 months

Secondary Outcomes

procedural success, amputation, target segment revascularization (TSR), target vessel revascularization (TVR), surgical revascularization, clinical restenosis defined by increase in Rutherford claudication grade of 1 or more

Time frame: 12 months

Data from ClinicalTrials.gov

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