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

NCT04110327 | Active Not Recruiting

• 1 other identifier: MMS-201
• Study Type: observational
• Target: 300
• Locations: 5 countries
• Sites: 10

Brief Summary

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

Conditions

Peripheral Arterial Disease; Critical Lower Limb Ischemia

Keywords

MicroStent; Below the Knee; CLI; Below the Ankle; CLTI

Outcome Measures

Primary Outcomes (2)

• Primary Patency

  Freedom from target lesion occlusion with no clinically driven target lesion revascularization (TLR)

  6 months post-procedure

• Freedom from Perioperative Death and Major Adverse Limb Events (MALE)

  Freedom from all-cause death or major adverse limb events. Major adverse limb events include above-ankle amputation, new bypass graft or graft revision, and thrombectomy or thrombolysis involving the target lesion.

  30 days post-procedure

Secondary Outcomes (6)

• Freedom from Major Adverse Limb Events

  6, 12, 24 Months

• Freedom from Major Amputation

  6, 12, 24 Months

• Freedom from Clinically Driven Target Lesion Revascularization (TLR)

  6, 12, 24 Months

• Wound Healing

  30 days, 6, 12, 24 Months

• Device Success

  Procedure

Interventions

MicroStent DEVICE

Treatment of arterial stenosis or occlusion with the MicroStent Peripheral Vascular Stent System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• For across the ankle joint intervention, distal runoff to digital branches or arcuate arteries must be present on angiography prior to MicroStent deployment
• Subject's age is ≥ 18 years.
• Subject must be willing to sign a patient informed consent form.

You may not qualify if:

• Subject is pregnant or planning to become pregnant during the study duration
• Subject has a life expectancy of less than one (1) year
• Subject has a known allergy to concomitant medication, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant or thrombolytic medications
• Subject is enrolled in another study that has not reached its primary endpoint at the time of enrollment.

Sponsors & Collaborators

• Micro Medical Solution, Inc.: lead

Study Sites (10)

Univ.-Klinikum LKH Graz

Graz, Austria

Location

OLV Hospital

Aalst, Belgium

Location

A.Z. Sint-Blasius

Dendermonde, Belgium

Location

ZOL Genk

Genk, Belgium

Location

Klinikum Hochsauerland - Karolinen Hospital

Arnsberg, Germany

Location

University Heart Center Freiburg - Bad Krozingen

Bad Krozingen, Germany

Location

University of Leipzig

Leipzig, Germany

Location

Policlinico Abano Terme

Abano Terme, Italy

Location

Maria Cecilia Hospital

Cotignola, Italy

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 1, 2019
• Study Start: October 31, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 22, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); BE (3); DE (3); AU (1); NL (1)