An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease

Last updated: September 17, 2025
Sponsor: Micro Medical Solution, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Peripheral Arterial Disease (Pad)

Peripheral Arterial Occlusive Disease

Atherosclerosis

Treatment

MicroStent

Clinical Study ID

NCT04110327
MMS-201
  • Ages > 18
  • All Genders

Study Summary

Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStent™ System.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Any subject with below the knee, at the ankle level or below the ankle peripheralarterial 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 orarcuate 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

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 cannotbe medically managed), anti-platelet, anti-coagulant or thrombolytic medications

  4. Subject is enrolled in another study that has not reached its primary endpoint atthe time of enrollment.

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: MicroStent
Phase:
Study Start date:
October 31, 2019
Estimated Completion Date:
December 31, 2028

Study Description

Subjects with peripheral arterial disease (PAD) whom the investigator has treated or intends to treat with the MicroStent™ System per the current instructions for use (IFU), and who have given written informed consent, will be enrolled in this study. Up to 300 subjects will be enrolled:

The objective of this post market registry is to evaluate procedural and long-term clinical outcomes for subjects undergoing intervention with the MicroStent® System for treatment of lower extremity peripheral arterial disease (PAD), presenting with below-the-knee lesions.

Connect with a study center

  • Univ.-Klinikum LKH Graz

    Graz,
    Austria

    Site Not Available

  • Univ.-Klinikum LKH Graz

    Graz 2778067,
    Austria

    Site Not Available

  • OLV Hospital

    Aalst,
    Belgium

    Site Not Available

  • OLV Hospital

    Aalst 2803448,
    Belgium

    Site Not Available

  • A.Z. Sint-Blasius

    Dendermonde,
    Belgium

    Site Not Available

  • A.Z. Sint-Blasius

    Dendermonde 2799645,
    Belgium

    Site Not Available

  • ZOL Genk

    Genk,
    Belgium

    Site Not Available

  • ZOL Genk

    Genk 2797670,
    Belgium

    Site Not Available

  • Klinikum Hochsauerland - Karolinen Hospital

    Arnsberg,
    Germany

    Site Not Available

  • Klinikum Hochsauerland - Karolinen Hospital

    Arnsberg 2955471,
    Germany

    Site Not Available

  • University Heart Center Freiburg - Bad Krozingen

    Bad Krozingen,
    Germany

    Site Not Available

  • University Heart Center Freiburg - Bad Krozingen

    Bad Krozingen 2953414,
    Germany

    Site Not Available

  • University of Leipzig

    Leipzig,
    Germany

    Site Not Available

  • University of Leipzig

    Leipzig 2879139,
    Germany

    Site Not Available

  • Policlinico Abano Terme

    Abano Terme,
    Italy

    Site Not Available

  • Policlinico Abano Terme

    Abano Terme 3183587,
    Italy

    Site Not Available

  • Maria Cecilia Hospital

    Cotignola,
    Italy

    Site Not Available

  • Maria Cecilia Hospital

    Cotignola 3177876,
    Italy

    Site Not Available

  • St. Antonius Ziekenhuis

    Nieuwegein,
    Netherlands

    Site Not Available

  • St. Antonius Ziekenhuis

    Nieuwegein 2750325,
    Netherlands

    Site Not Available

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