A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Dise… (NCT03477604) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)
United States177 participantsStarted 2020-03-31
Plain-language summary
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.
Who can participate
Age range21 Years
SexALL
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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.
✓. 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
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.