Local Paclitaxel Delivery for SFA Disease

Not Applicable

Completed

• Conditions: Atherosclerosis; Angioplasty; Peripheral Arterial Disease
• Interventions: Drug: Paclitaxel

• Registration Number: NCT00821028
• Lead Sponsor: University of Oklahoma

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 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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-05
• Study First Submitted QC: 2009-01-09
• Study First Posted: 2009-01-12
• Primary Completion: 2011-12
• Study Completion: 2012-04
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-14
• Last Update Posted: 2017-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel	Paclitaxel	Participants will receive Paclitaxel.

Primary Outcome Measures

Name	Time	Method
Superficial femoral artery late lumen loss	12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States