临床试验/NCT00821028

NCT00821028已完成不适用

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

University of Oklahoma1 个研究点分布在 1 个国家目标入组 27 人开始时间: 2009年1月最近更新: 2017年8月17日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Oklahoma
入组人数: 27
试验地点: 1
主要终点: Superficial femoral artery late lumen loss

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•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

研究组 & 干预措施

Paclitaxel

Experimental

Participants will receive Paclitaxel.

干预措施: Paclitaxel (Drug)

结局指标

主要结局

Superficial femoral artery late lumen loss

时间窗: 12 months

次要结局

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(12 months)

研究者

发起方

University of Oklahoma

申办方类型

Other

责任方

Sponsor

研究点 (1)

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