Paclitaxel Reduces Effects of Intimal Hyperplasia

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. Once the subject is
enrolled they will be monitored for a period of 19 months. 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.

Inclusion Criteria:

- ability to provide informed consent

- age 18-90 years old

- Rutherford 1-6

- occlusion or stenosis in the infrainguinal vessels

Exclusion Criteria:

- inability to pass the guide wire across the lesion

- pregnant or lactating women

- specific limb has not been previously treated with endovascular intervention