Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2009-01-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Paclitaxel
Participants will receive Paclitaxel.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Patients must be on appropriate pharmacologic therapy for PAD including antiplatelet agents and lipid-lowering therapy.
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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University of Oklahoma
OTHER
Responsible Party
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Principal Investigators
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Mazen Abu-Fadel, M.D.
Role: PRINCIPAL_INVESTIGATOR
Univeristy of Oklahoma
Locations
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Countries
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Other Identifiers
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Atrium-001
Identifier Type: -
Identifier Source: org_study_id
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