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.

Study Overview

• Status: Active, not recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: MicroStent and Standard PTA; Device: Standard PTA

• Study Type: Interventional
• Enrollment (Actual): 177
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Patency of the target lesion	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	Freedom from perioperative death	up to 30 days after randomization
Freedom from major adverse limb event	Freedom from major adverse limb event	up to 6 months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from major amputation above the ankle	Freedom from major amputation (above the ankle)	up to 6 months after randomization
Reduction in size of ischemic leg/foot ulcers	Reduction in size of ischemic leg/foot ulcers	up to 6 months after randomization
Freedom from major adverse limb event	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	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

• Sponsor: Micro Medical Solution, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2020
• Primary Completion (Actual): June 5, 2025
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: March 8, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Stent; Below the knee
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID 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