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
  Purpose

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


Condition Intervention
Atherosclerosis
Angioplasty
Peripheral Arterial Disease
Drug: Paclitaxel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Superficial Femoral Artery Atherosclerotic Disease With Local Delivery of Paclitaxel Using an Irrigating Catheter: a Randomized, Single-center Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Superficial femoral artery late lumen loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 27
Study Start Date: January 2009
Study Completion Date: April 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821028

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73126
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Mazen Abu-Fadel, M.D. Univeristy of Oklahoma
  More Information

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00821028     History of Changes
Other Study ID Numbers: Atrium-001
Study First Received: January 5, 2009
Last Updated: December 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Oklahoma:
atherosclerosis
angioplasty
peripheral arterial disease

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014