Study to Evaluate the Safety and Performance of the Xpert(TM) Stent in Treating Below-the-Knee Lesions in Patients Undergoing Percutaneous Intervention for Chronic Critical Limb Ischemia

Peripheral arterial disease (PAD) of the lower extremities affects roughly 25 million
Americans annually. The diabetic population is particularly prone to the most severe
clinical problems associated with PAD and the amputation rate amongst such patients is
elevated five-fold. It has been shown that patients who undergo amputation for PAD/CLI have
a much higher mortality rate in the months that follow.

Despite medical advances in the fields of pharmacology and wound care, the vast majority of
patients who present with CLI will ultimately require amputation in the absence of improved
blood flow. Recently, much attention has been directed towards less invasive endovascular
solutions for treating patients with CLI. This study will evaluate approximately 140
subjects with Rutherford Class IV-VI PAD in a multi-center study in order to accurately
estimate limb salvage rates for this treatment.

Inclusion Criteria:

- Patient has documented wound care greater than or equal to 2 weeks prior to
enrollment

- Subject understands the duration of the study and its follow up visit requirements

- Female subjects of childbearing potential have a negative pregnancy test less than 7
days before the procedure and are willing to use a reliable method of birth control
for the duration of study participation

- Subject has documented chronic critical limb ischemia in the target limb for two
weeks with Rutherford Category 4, 5 or 6

- Subject must have one of 5 approved non-invasive test results of the target limb
within two weeks of enrollment.

Exclusion Criteria:

- Life expectancy of less than 12 months

- Cerebrovascular accident (CVA) or myocardial infarction (MI) within 3 months prior to
enrollment

- Inability to walk (with assistance is accepted)

- Previous bypass surgery to target limb less than 30 days prior to study procedure

- Acute thrombus at the lesion site(s)