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

NCT ID NCT03477604

Ongoing 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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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

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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