A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects with Arterial Disease Below the Knee (STAND)
Randomized multicenter clinical trial consisting of two arms; one arm treated with PTA plus the MicroStent® System and one arm treated with PTA alone. Purpose to evaluate the safety and effectiveness of using the MicroStent® Peripheral Vascular Stent System, hereafter referred to as the MicroStent® System, for the treatment of infrapopliteal lesions in subjects with peripheral arterial disease.
• Subject is a male or a non-pregnant female adult between the age of 21 and 90 years old.
• Subject has documented clinical evidence of critical limb ischemia (CLI) in the target limb prior to the index procedure, with a Rutherford Classification score of 4-5.
• The 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 willing to comply with all required follow-up visits.
• Subject life expectancy is ≥1 year per the Principal Investigator.
• Angiographic Inclusion Criteria
• Target vessel reconstitutes at or above the ankle with inline flow to at least one patent (\<50% stenosis) inframalleolar outflow vessel.
• Subject has a lesion, with ≥ 70% stenosis and ≤ 12.0 cm in length located at or distal to the tibial-peroneal trunk and above the tibiotalar joint; including the anterior tibial, posterior tibial or peroneal arteries.
• Target lesion has a reference vessel diameter of 2.5 - 4.5 mm
• The target lesion is able to be crossed with a guidewire to facilitate treatment with the randomized device.