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

Study Overview
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Brief Summary
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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.

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

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: MicroStent and Standard PTA
* Device: Standard PTA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MicroStent and Standard PTA<br>Implant of the MicroStent peripheral vascular stent system for treatment of arterial lesions below the knee. | Device: MicroStent and Standard PTA<br>* Self-expanding stent and standard PTA balloon<br>|
| Active Comparator: Standard PTA<br> | Device: Standard PTA<br>* Standard PTA balloon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency of the target lesion | Primary patency defined as freedom from target lesion occlusion with no clinically driven target lesion reintervention, or major amputation. | up to 6 months after randomization | 
| Freedom from perioperative death | Freedom from perioperative death | up to 30 days after randomization | 
| Freedom from major adverse limb event | Freedom from major adverse limb event | up to 6 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from major amputation above the ankle | Freedom from major amputation (above the ankle) | up to 6 months after randomization | 
| Reduction in size of ischemic leg/foot ulcers | Reduction in size of ischemic leg/foot ulcers | up to 6 months after randomization | 
| Freedom from major adverse limb event | Freedom from major adverse limb event | From date of randomization until the date of death from any cause assessed up to 36 months | 
| Frequency and severity of serious adverse events and device and procedure related adverse events | Frequency and severity of serious adverse events and device and procedure-related adverse events at any time during the study. | From date of randomization until the date of death from any cause assessed up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Below the knee, Stent