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

Egyéb feltételek

• General Inclusion Criteria:
• 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; General Exclusion Criteria:
• Subject had a prior or has a planned index limb amputation above the ankle
• Subject has a wound/ulcer on the forefoot with a surface area >4cm² or osteomyelitis involving the calcaneus bone
• Subject is pregnant, plans to become pregnant, or is nursing
• Subject has clinical conditions that severely inhibit X-ray or duplex ultrasound visualization (e.g. body habitus)
• Subject has a history of hypercoagulation/clotting disorders or acute thrombosis
• Subject has allergy to iodinated contrast media that cannot be adequately managed with medication
• Subject is in acute renal failure
• Subject has an 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 randomization/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 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 had a stroke within 3 months of index procedure; Angiographic exclusion criteria
• Failure to successfully treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or popliteal arteries. Successful treatment is defined as obtaining ≤30% residual stenosis with no major procedural complications (e.g embolism)
• Failure to successfully treat significant non-target infra-popliteal lesions. Successful treatment is defined as obtaining ≤30% residual stenosis with no major procedural complications (e.g. embolism)
• Target lesion is within a previously placed stent