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.
- Peripheral Arterial Disease
- Eligible Ages
- Over 21 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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
6. Target vessel reconstitutes at or above the ankle with inline flow to at least one patent (<50% stenosis) inframalleolar outflow vessel.
7. 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.
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 treatment with the randomized device.
- 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
14. 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).
15. 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).
16. Target lesion is within a previously placed stent.
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- None (Open Label)
MicroStent and Standard PTA
|Implant of the MicroStent peripheral vascular stent system for treatment of arterial lesions below the knee.||
- Micro Medical Solution, Inc.
Study ContactKate Mandall