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

Last updated: December 2, 2024
Sponsor: Micro Medical Solution, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Peripheral Arterial Disease (Pad)

Peripheral Arterial Occlusive Disease

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

    Active - Recruiting

  • OLV Hospital

    Aalst,
    Belgium

    Active - Recruiting

  • A.Z. Sint-Blasius

    Dendermonde,
    Belgium

    Active - Recruiting

  • ZOL Genk

    Genk,
    Belgium

    Active - Recruiting

  • Klinikum Hochsauerland - Karolinen Hospital

    Arnsberg,
    Germany

    Active - Recruiting

  • University Heart Center Freiburg - Bad Krozingen

    Bad Krozingen,
    Germany

    Active - Recruiting

  • University of Leipzig

    Leipzig,
    Germany

    Active - Recruiting

  • Policlinico Abano Terme

    Abano Terme,
    Italy

    Active - Recruiting

  • Maria Cecilia Hospital

    Cotignola,
    Italy

    Active - Recruiting

  • St. Antonius Ziekenhuis

    Nieuwegein,
    Netherlands

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.