Local Paclitaxel Delivery for SFA Disease (IRRITAX)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00821028
First received: January 5, 2009
Last updated: December 19, 2013
Last verified: December 2013

January 5, 2009
December 19, 2013
January 2009
December 2011   (final data collection date for primary outcome measure)
Superficial femoral artery late lumen loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00821028 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Local Paclitaxel Delivery for SFA Disease
Treatment of Superficial Femoral Artery Atherosclerotic Disease With Local Delivery of Paclitaxel Using an Irrigating Catheter: a Randomized, Single-center Pilot Study

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Atherosclerosis
  • Angioplasty
  • Peripheral Arterial Disease
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
Experimental: Experimental
Intervention: Drug: Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
April 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00821028
Atrium-001
Yes
University of Oklahoma
University of Oklahoma
Not Provided
Principal Investigator: Mazen Abu-Fadel, M.D. Univeristy of Oklahoma
University of Oklahoma
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP