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

  • STATUS
    Recruiting
  • End date
    Mar 1, 2024
  • participants needed
    177
  • sponsor
    Micro Medical Solution, Inc.
Updated on 21 April 2022
arteriopathy
stenosis
ischemia
vascular disease
limb ischemia
critical limb ischaemia

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.

Details
Condition Peripheral Arterial Disease
Treatment standard PTA, MicroStent and Standard PTA
Clinical Study IdentifierNCT03477604
SponsorMicro Medical Solution, Inc.
Last Modified on21 April 2022

Eligibility

Yes No Not Sure

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

Exclusion Criteria

Subject has a wound/ulcer on the forefoot with a surface area >4cm² or osteomyelitis involving the calcaneus bone
Subject had a prior or has a planned index limb amputation above the ankle
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
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)
Subject has experienced myocardial infarction, thrombolysis, or angina less than 30 days prior to the index procedure
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)
Subject had a stroke within 3 months of index procedure
Target lesion is within a previously placed stent
Angiographic exclusion criteria
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