New stent aims to save legs from amputation in severe artery disease

NCT ID NCT03477604

Disease control Sponsor: Micro Medical Solution, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new device called the MicroStent, a small mesh tube placed in leg arteries below the knee to keep them open. It involves 177 adults with severe peripheral artery disease who have pain at rest or non-healing sores. Half get the stent plus standard balloon treatment, the other half get balloon treatment alone. The goal is to see if the stent helps keep arteries open longer and prevents major complications like amputation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: MicroStent (a self-expanding stent) used with standard balloon angioplasty
What this could lead to: If successful, this stent could offer a better way to keep arteries open below the knee, reducing the need for repeat procedures and lowering the risk of amputation in people with severe leg artery disease.
What could go wrong: This is a mid-stage trial with 177 participants, so results may not apply to everyone. Stents can fail due to re-blockage or movement, and the procedure carries risks like bleeding or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

177 people

The number who actually took part.

Started

Mar 2020

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

limb ischemia peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peripheral arterial disease

Contacts and locations

Locations

AMI Vascular Institute

Galloway, New Jersey, 08205, United States
AZH/WAVE Vascular Center

Milwaukee, Wisconsin, 53221, United States
Advanced Cardiac and Vascular Amputation Prevention Centers

Grand Rapids, Michigan, 49525, United States
Advent Health Sebring

Sebring, Florida, 33872, United States
Brown University

Providence, Rhode Island, 02904, United States
Cardiology Consultants

Spartanburg, South Carolina, 29303, United States
Cardiothoracic and Vascular Surgeons

Austin, Texas, 78756, United States
Cardiovascular Associates of the Southeast

Birmingham, Alabama, 35243, United States
Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States
Copper State Vascular

Mesa, Arizona, 85203, United States
Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States
FHV Health

Leesburg, Florida, 34748, United States
First Coast Cardiovascular Institute

Jacksonville, Florida, 32256, United States
Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States
North Jersey Vascular Center

Clifton, New Jersey, 07013, United States
Palm Vascular

Fort Lauderdale, Florida, 33312, United States
Rocky Mountain Regional VA Medical Center

Aurora, Colorado, 80045, United States
St. Helena Hospital

St. Helena, California, 94574, United States
US Cardiovascular

Jefferson Hills, Pennsylvania, 15025, United States
University of Maryland - Baltimore

Baltimore, Maryland, 21201, United States
Vascular Institute of the Midwest

Davenport, Iowa, 52807, United States

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