NCT00821028

Local Paclitaxel Delivery for SFA Disease

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atherosclerosis
• Angioplasty
• Peripheral Arterial Disease

Interventions

Type	Name	Description
DRUG	Paclitaxel	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

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-12-01
• Completion: 2012-04-01
• First posted: 2009-01-12
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States