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

March 31, 2026 updated by: Micro Medical Solution, Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
177

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • Cardiovascular Associates of the Southeast
    • Arizona
      • Mesa, Arizona, United States, 85203
        • Copper State Vascular
    • California
      • St. Helena, California, United States, 94574
        • St. Helena Hospital
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Rocky Mountain Regional VA Medical Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33312
        • Palm Vascular
      • Jacksonville, Florida, United States, 32256
        • First Coast Cardiovascular Institute
      • Leesburg, Florida, United States, 34748
        • FHV Health
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Sebring, Florida, United States, 33872
        • Advent Health Sebring
    • Iowa
      • Davenport, Iowa, United States, 52807
        • Vascular Institute of the Midwest
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Cardiovascular Institute of the South
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland - Baltimore
    • Michigan
      • Grand Rapids, Michigan, United States, 49525
        • Advanced Cardiac and Vascular Amputation Prevention Centers
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Deborah Heart and Lung Center
      • Clifton, New Jersey, United States, 07013
        • North Jersey Vascular Center
      • Galloway, New Jersey, United States, 08205
        • AMI Vascular Institute
    • Pennsylvania
      • Jefferson Hills, Pennsylvania, United States, 15025
        • US Cardiovascular
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Brown University
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Cardiology Consultants
    • Texas
      • Austin, Texas, United States, 78756
        • Cardiothoracic and Vascular Surgeons
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53221
        • AZH/WAVE Vascular Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

General 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.

    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.

General 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.
  11. Subject presents with acute limb ischemia or acute thrombosis of the target limb.
  12. Subject has experienced myocardial infarction, thrombolysis, or angina less than 30 days prior to the index procedure.

  13. 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MicroStent and Standard PTA
Implant of the MicroStent peripheral vascular stent system for treatment of arterial lesions below the knee.
Device: MicroStent and Standard PTA
Self-expanding stent and standard PTA balloon
Active Comparator: Standard PTA
Device: Standard PTA
Standard PTA balloon

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patency of the target lesion
Time Frame: up to 6 months after randomization
Primary patency defined as freedom from target lesion occlusion with no clinically driven target lesion reintervention, or major amputation.
up to 6 months after randomization
Freedom from perioperative death
Time Frame: up to 30 days after randomization
Freedom from perioperative death
up to 30 days after randomization
Freedom from major adverse limb event
Time Frame: up to 6 months after randomization
Freedom from major adverse limb event
up to 6 months after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Freedom from major amputation above the ankle
Time Frame: up to 6 months after randomization
Freedom from major amputation (above the ankle)
up to 6 months after randomization
Reduction in size of ischemic leg/foot ulcers
Time Frame: up to 6 months after randomization
Reduction in size of ischemic leg/foot ulcers
up to 6 months after randomization
Freedom from major adverse limb event
Time Frame: From date of randomization until the date of death from any cause assessed up to 36 months
Freedom from major adverse limb event
From date of randomization until the date of death from any cause assessed up to 36 months
Frequency and severity of serious adverse events and device and procedure related adverse events
Time Frame: From date of randomization until the date of death from any cause assessed up to 36 months
Frequency and severity of serious adverse events and device and procedure-related adverse events at any time during the study.
From date of randomization until the date of death from any cause assessed up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Micro Medical Solution, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 5, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MMS-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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