A Clinical Feasibility Evaluation of the MicroStent Peripheral Vascular Stent in Subjects With Artery Lesions Below the Knee

General Inclusion Criteria:

- Subject is male or non-pregnant female adult over the age of 21

- Subject has documented clinical evidence of critical limb ischemia (CLI) in the target
limb prior to the study procedure, with a Rutherford classification score of 4-5

- Subject, or subject's designated legal representative, has been informed of the nature
of the study and is willing to provide written informed consent

- Subject is geographically stable and is able and willing to comply with all study
required follow up visits.

- Subject has a life expectancy > 1 year

Angiographic Inclusion Criteria

- Target limb has at least a single vessel with runoff to the foot

- Subject has up to 3 non-contiguous lesions, each with >=70% stenosis and <=5.0cm in
length located at or distal to the tibial-peroneal trunk and above the ankle;
including the anterior tibial, posterior tibial, or peroneal arteries

- Target lesion(s) has a reference vessel diameter of 2.5 - 4.5mm to accommodate the
test article.

- Target lesion(s) is able to be crossed with a guidewire to facilitate treatment with
the study device.

General Exclusion Criteria:

- Subject has a prior or planned index limb amputation above the ankle.

- Subject has a wound/ulcer located on the target limb with a Wound, Ischemia, and foot
Infection (WIfI) infection grade >1

- Subject is pregnant, plans to become pregnant, or is nursing.

- Subject is morbidly obese or has other clinical conditions that severely inhibit X-ray
visualization

- Subject has a history of coagulation/clotting disorders, acute thrombosis, or is
hypercoagulable

- Subject has allergy to iodinated contrast media

- Subject is in acute renal failure

- Subject has active systemic infection

- Subject is participating in another research study involving an investigational
device, biologic, or drug that has not completed the primary endpoint at the time of
enrollment

- Subject has other comorbidities that, in the opinion of the investigator, preclude
them from receiving study treatment and/or from completing the required study follow
up assessments.

- Subject has had any non-diagnostic endovascular or surgical procedure in the lower
extremities less than 14 days prior or planned less than 30 days after the index
procedure

- Subject presents with acute limb ischemia or acute thrombosis of the target limb.

- Subject has experienced myocardial infarction, thrombolysis, or angina less than 30
days prior to the index procedure.

- Subject has a history of stroke within 3 months of the index procedure.

Angiographic exclusion criteria

- Presence of hemodynamically significant inflow lesions >15cm in length

- Failure to obtain <= 30% residual stenosis in hemodynamically significant inflow
lesions <=15cm in length

- Failure to obtain <=30% residual stenosis in hemodynamically significant non-target
infrapopliteal lesions

- In the opinion of the investigator, subject may require use of alternative therapy
(e.g. atherectomy, etc.)