Effects of Paclitaxel on Intimal Hyperplasia
Condition: Peripheral Vascular Disease
MeSH terms: Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Hyperplasia
Study type: Interventional

Summary: 
      This is a single, one time, limited dose infusion of Paclitaxel, that will potentially
      prevent recurrent stenosis secondary to intimal hyperplasia when compared to the control
      group at 10 months.
    

Detailed description: 
      The investigators study consists of enrolling subjects that are already scheduled to have the
      blood vessels in their legs re-opened. The entire study is considered standard of care,
      except the administration of Paclitaxel. Subjects will be consented prior to any study
      related procedures and prior to procedure. Subjects that meet inclusion/exclusion and the
      infusion of Paclitaxel has been given, will then be enrolled in the study. After the plaque
      area has been treated with either angioplasty (inflation of a balloon compacting it against
      the artery wall), stent (a wire mesh tube that presses the plaque against the artery wall and
      opens the artery), and/or atherectomy(removal of plaque from the artery), Dr Kelly, Dr.
      Schultz, Dr, Laurich, or Dr. Santos will then use an infusion balloon (a balloon with an
      outer layer that has holes that allows a medication to be given) to administer the
      Paclitaxel. Every time the infusion balloon is blown up, a single dose of medication
      (Paclitaxel) will be applied to the target lesion. This will be repeated until all of the
      target lesions have been treated or a maximum dose of 10 mg of Paclitaxel has been given. All
      persons enrolled in this study will be treated with Paclitaxel. Subjects are expected to
      attend all follow up visits. These visits would occur even if the subject were not on the
      trial. Ankle-brachial index (ABI) (done by measuring blood pressure at the ankle and in the
      arm while a person is at rest. This test indicates if leg blockages are present) and Duplexes
      (An ultrasound that measures blood flow rates through the vessels. This test will indicate if
      leg blockages are present) will be done at the follow up visits. Both of these tests and all
      follow up visits are considered standard of care and will be charged to the subject or
      subject's insurance.
    

Intervention name(s): Paclitaxel
Intervention type(s): Drug
Intervention description(s): Paclitaxel in addition to angioplasty, stenting or atherectomy Dosing will be based on the 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
Paclitaxel Dosage:
Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*
not to exceed 10mg total dose
Other intervention name(s): Taxol, Onxol
Intervention MeSH terms: Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: restenosis; peripheral vascular disease; lower extremity ischemia; claudication