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New stent study aims to keep leg arteries open and prevent amputations

NCT ID NCT04110327

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 30, 2026 · Updated 2 times

Summary

This study is following 300 people with peripheral artery disease who received the MicroStent, a small mesh tube placed in leg arteries to improve blood flow. Researchers are tracking how well the arteries stay open over time and whether patients avoid major complications like amputation or the need for additional procedures. The goal is to see how the stent performs in everyday medical practice.

What this could mean

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

Active substance
MicroStent peripheral vascular stent system (a small mesh tube placed in leg arteries to keep them open)
What this could lead to
If successful, this study could confirm that the MicroStent is a safe and effective option for treating blocked leg arteries, helping people with peripheral artery disease avoid amputation.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. The device is already approved for use, so this study is mainly gathering real-world data rather than testing a new breakthrough.

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.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2019

Expected to finish

Dec 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.

Who is studied

The study population will include any subject with symptomatic peripheral arterial disease (PAD) that require intervention with the MicroStent™ System.

Ages

18 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.

Inclusion Criteria: 1. Any subject with below the knee, at the ankle level or below the ankle peripheral arterial lesions previously treated or intended to be treated with the MicroStent® System per the current indications for use 2. For across the ankle joint intervention, distal runoff to digital branches or arcuate arteries must be present on angiography prior to MicroStent deployment 3. Subject's age is ≥ 18 years. 4. Subject must be willing to sign a patient informed consent form. Exclusion Criteria: 1. Subject is pregnant or planning to become pregnant during the study duration 2. Subject has a life expectancy of less than one (1) year 3. Subject has a known allergy to concomitant medication, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant or thrombolytic medications 4. Subject is enrolled in another study that has not reached its primary endpoint at the time of enrollment.

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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.

Critical lower limb ischemia Peripheral arterial disease

Contacts and locations

Locations

  • A.Z. Sint-Blasius

    Dendermonde, Belgium

  • Klinikum Hochsauerland - Karolinen Hospital

    Arnsberg, Germany

  • Maria Cecilia Hospital

    Cotignola, Italy

  • OLV Hospital

    Aalst, Belgium

  • Policlinico Abano Terme

    Abano Terme, Italy

  • St. Antonius Ziekenhuis

    Nieuwegein, Netherlands

  • Univ.-Klinikum LKH Graz

    Graz, Austria

  • University Heart Center Freiburg - Bad Krozingen

    Bad Krozingen, Germany

  • University of Leipzig

    Leipzig, Germany

  • ZOL Genk

    Genk, Belgium

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