A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)

General Inclusion Criteria:

1. Subject is a male or a non-pregnant female adult between the age of 21 and 90 yearsold.

2. Subject has documented clinical evidence of critical limb ischemia (CLI) in thetarget limb prior to the index procedure, with a Rutherford Classification score of 4-5.

3. The subject, or subject's designated legal representative, has been informed of thenature of the study and is willing to provide written informed consent.

4. Subject is willing to comply with all required follow-up visits.

5. Subject life expectancy is ≥1 year per the Principal Investigator. Angiographic Inclusion Criteria

6. Target vessel reconstitutes at or above the ankle with inline flow to at least onepatent (<50% stenosis) inframalleolar outflow vessel.

7. Subject has a lesion, with ≥ 70% stenosis and ≤ 12.0 cm in length located at ordistal to the tibial-peroneal trunk and above the tibiotalar joint; including theanterior tibial, posterior tibial or peroneal arteries.

8. Target lesion has a reference vessel diameter of 2.5 - 4.5 mm

9. The target lesion is able to be crossed with a guidewire to facilitate treatmentwith the randomized device.

General Exclusion Criteria:

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

2. Subject has a wound/ulcer on the forefoot with a surface area >4cm² or osteomyelitisinvolving the calcaneus bone.

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

4. Subject has clinical conditions that severely inhibit X-ray or duplex ultrasoundvisualization (e.g. body habitus).

5. Subject has a history of hypercoagulation/clotting disorders or acute thrombosis.

6. Subject has allergy to iodinated contrast media that cannot be adequately managedwith medication.

7. Subject is in acute renal failure.

8. Subject has an active systemic infection.

9. Subject is participating in another research study involving an investigationaldevice, biologic, or drug that has not completed the primary endpoint at the time ofrandomization/enrollment.

10. Subject has other comorbidities that - in the opinion of the investigator - precludethem from receiving study treatment and/or from completing the required studyfollow-up assessments.

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

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

13. Subject had a stroke within 3 months of index procedure. Angiographic exclusion criteria

14. Failure to successfully treat clinically significant inflow lesions in theipsilateral iliac, femoral, or popliteal arteries. Successful treatment is definedas obtaining ≤30% residual stenosis with no major procedural complications (e.gembolism).

15. Failure to successfully treat significant non-target infra-popliteal lesions.Successful treatment is defined as obtaining ≤30% residual stenosis with no majorprocedural complications (e.g. embolism).

16. Target lesion is within a previously placed stent.