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Local Paclitaxel Delivery for SFA Disease (IRRITAX)

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ClinicalTrials.gov Identifier: NCT00821028
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

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

Condition or disease Intervention/treatment
Atherosclerosis Angioplasty Peripheral Arterial Disease Drug: 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Superficial Femoral Artery Atherosclerotic Disease With Local Delivery of Paclitaxel Using an Irrigating Catheter: a Single-center Pilot Study
Study Start Date : January 2009
Primary Completion Date : December 2011
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
Drug Information available for: Paclitaxel
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Paclitaxel
Participants will receive Paclitaxel.
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



Primary Outcome Measures :
  1. Superficial femoral artery late lumen loss [ Time Frame: 12 months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00821028     History of Changes
Other Study ID Numbers: Atrium-001
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017

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

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