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

NCT03477604 | Active Not Recruiting DMC FDA Device

• 1 other identifier: MMS-001
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 21

Brief 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.

Conditions

Peripheral Arterial Disease

Keywords

Below the knee; Stent

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Freedom from major amputation above the ankle

  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

  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

  From date of randomization until the date of death from any cause assessed up to 36 months

Study Arms (2)

MicroStent and Standard PTA

EXPERIMENTAL

Implant of the MicroStent peripheral vascular stent system for treatment of arterial lesions below the knee.

Device: MicroStent and Standard PTA

Standard PTA

ACTIVE COMPARATOR

Device: Standard PTA

Interventions

MicroStent and Standard PTA DEVICE

Self-expanding stent and standard PTA balloon

MicroStent and Standard PTA

Standard PTA DEVICE

Standard PTA balloon

Standard PTA

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• The target lesion is able to be crossed with a guidewire to facilitate treatment with the randomized device.

You may not qualify if:

• 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.
• 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.
• Subject has experienced myocardial infarction, thrombolysis, or angina less than 30 days prior to the index procedure.
• Subject had a stroke within 3 months of index procedure.
• 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).
• 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).

Sponsors & Collaborators

• Micro Medical Solution, Inc.: lead

Study Sites (21)

Cardiovascular Associates of the Southeast

Birmingham, Alabama, 35243, United States

Location

Copper State Vascular

Mesa, Arizona, 85203, United States

Location

St. Helena Hospital

St. Helena, California, 94574, United States

Location

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, 80045, United States

Location

Palm Vascular

Fort Lauderdale, Florida, 33312, United States

Location

First Coast Cardiovascular Institute

Jacksonville, Florida, 32256, United States

Location

FHV Health

Leesburg, Florida, 34748, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Advent Health Sebring

Sebring, Florida, 33872, United States

Location

Vascular Institute of the Midwest

Davenport, Iowa, 52807, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

University of Maryland - Baltimore

Baltimore, Maryland, 21201, United States

Location

Advanced Cardiac and Vascular Amputation Prevention Centers

Grand Rapids, Michigan, 49525, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

North Jersey Vascular Center

Clifton, New Jersey, 07013, United States

Location

AMI Vascular Institute

Galloway, New Jersey, 08205, United States

Location

US Cardiovascular

Jefferson Hills, Pennsylvania, 15025, United States

Location

Brown University

Providence, Rhode Island, 02904, United States

Location

Cardiology Consultants

Spartanburg, South Carolina, 29303, United States

Location

Cardiothoracic and Vascular Surgeons

Austin, Texas, 78756, United States

Location

AZH/WAVE Vascular Center

Milwaukee, Wisconsin, 53221, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 26, 2018
• Study Start: March 31, 2020
• Primary Completion: December 5, 2024
• Study Completion (Estimated): March 1, 2028
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)