Cilostazol After Lower Extremity Arterial Revascularization Trial

Cilostazol is the only medication approved for use in peripheral arterial disease (PAD)
patients to reduce claudication symptoms. Contemporary data has demonstrated that Cilostazol
improves patency after endovascular interventions in multiple randomized trials and
retrospective studies done in Japan in both critical limb ischemia and claudication patients.
However, Cilostazol use after peripheral revascularization has been sporadic and there has
been no research to estimate patient quality of life with use of Cilostazol after open or
endovascular lower extremity revascularization.

This is a prospective investigator initiated single-center open-label, non-placebo controlled
pilot study. Eligible patients would be randomized to either the Cilostazol treatment or the
non-Cilostazol treatment groups using a closed envelope randomization technique. Twenty
patients will be recruited and randomized; Ten to the treatment group and tento the control
group.

The primary purpose of this pilot study is to collect quality of life data on patients
undergoing peripheral revascularization in order to determine the sample size required for
adequate powered trial of Cilostazol versus usual care without Cilostazol and its effect on
Quality of Life.

Inclusion Criteria:

- At least 35 years of age

- Atherosclerotic peripheral arterial disease

- Able to provide informed consent

- Lower extremity open or endovascular revascularization.

Exclusion Criteria:

- Known CHF (class III/IV)

- Allergic reaction to phosphodiasterase inhibitors

- Intracranial bleeding within 3 months or active bleeding peptic ulcer disease

- Traumatic vascular injuries requiring revascularization

- Pregnant or breast feeding women or women who plan to get pregnant over the study
period

- Planned ipsilateral major amputation within 30 days of index procedure

- Moderate to severe hepatic impairment.