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OpenTrials
Completed

NCT Number: NCT00821028

Local Paclitaxel Delivery for SFA Disease

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

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Key information

Conditions

Atherosclerosis Angioplasty Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73126, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paclitaxel

Drug

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

Primary outcomes

  1. Superficial femoral artery late lumen loss

    Time frame: 12 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Acronym: IRRITAX

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jan 12, 2009
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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