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

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

NCT03477604•Micro Medical Solution, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject is a male or a non-pregnant female adult between the age of 21 and 90 years old.
•2. 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.
•3. 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.
•4. Subject is willing to comply with all required follow-up visits.
•5. Subject life expectancy is ≥1 year per the Principal Investigator.
•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.

Exclusion Criteria

•1. Subject had a prior or has a planned index limb amputation above the ankle.
•2. Subject has a wound/ulcer on the forefoot with a surface area \>4cm² or osteomyelitis involving the calcaneus bone.
•3. Subject is pregnant, plans to become pregnant, or is nursing.
•4. Subject has clinical conditions that severely inhibit X-ray or duplex ultrasound visualization (e.g. body habitus).
•5. Subject has a history of hypercoagulation/clotting disorders or acute thrombosis.
•6. Subject has allergy to iodinated contrast media that cannot be adequately managed with medication.
•7. Subject is in acute renal failure.
•8. Subject has an active systemic infection.
•9. 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.
•10. 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.
+6 more criteria

Locations (21)

Cardiovascular Associates of the Southeast

Birmingham, Alabama, United States

Copper State Vascular

Mesa, Arizona, United States

St. Helena Hospital

St. Helena, California, United States

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, United States

Palm Vascular

Fort Lauderdale, Florida, United States

First Coast Cardiovascular Institute

Jacksonville, Florida, United States

FHV Health

Leesburg, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

Advent Health Sebring

Sebring, Florida, United States

Vascular Institute of the Midwest

Davenport, Iowa, United States

Key Dates

Start Date

March 31, 2020

Primary Completion Date

December 5, 2024

Completion Date

March 1, 2028

Last Updated

November 14, 2025

Enrollment

177

ACTUAL participants

Conditions

Peripheral Arterial Disease

Interventions

MicroStent and Standard PTA

DEVICE

Standard PTA

DEVICE

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

NCT07472049

Peripheral Arterial DiseaseChronic Limb Threatening Ischemia

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RECRUITING

Advanta VXT and Flixene PMCF Registry

NCT07161583

Peripheral Arterial Disease

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

Advanta VXT and Flixene PMCF Registry

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

VITUS Post-Market Registry

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