A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)
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This prospective pivotal study is a double arm, randomized multi-center study evaluating the safety and performance of the MicroStent peripheral vascular stent system for use in arterial lesions below the knee. A total of 177 subjects will be enrolled at up to 25 centers and followed for up to 3 years, with the primary safety and efficacy endpoints evaluated 30 days and 6 months, respectively, post-implant.
Condition or disease
Peripheral Arterial Disease
Device: MicroStent or percutaneous transluminal angioplasty (PTA)
Freedom from perioperative death (POD) [ Time Frame: 30 days post index procedure ]
Primary Safety Endpoint
Freedom from major adverse limb event (MALE) [ Time Frame: 6 months post index procedure ]
Primary Safety Endpoint
Freedom from major amputation [ Time Frame: 6 months post index procedure ]
Primary Effectiveness Endpoint
Freedom from target lesion occlusion with no clinically driven target lesion reintervention (TLR) [ Time Frame: 6 months post index procedure ]
Primary Effectiveness Endpoint
Secondary Outcome Measures :
Freedom from major adverse limb event (MALE) [ Time Frame: 30 days, 3 months, 6 months, 1 year, 2 year, and 3 years post index procedure ]
Secondary Safety Endpoint #1
Frequency and severity of serious adverse events and device and procedure-related adverse events. [ Time Frame: Post randomization, 30 days, 3 months, 6 months, 1 year, 2 year, and 3 years post randomization ]
Secondary Safety Endpoint #2
Freedom from major amputation (above the ankle) [ Time Frame: 6 months post index procedure ]
Secondary Effectiveness Endpoint #1
Reduction in size of ischemic leg/foot ulcers [ Time Frame: 6 months post index procedure ]
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Layout table for eligibility information
Ages Eligible for Study:
21 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.