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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Peripheral Arterial Disease; Critical Lower Limb Ischemia
• Intervention / Treatment: Device: MicroStent

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • Univ.-Klinikum LKH Graz
• Belgium
  • Aalst, Belgium
    • OLV Hospital
  • Dendermonde, Belgium
    • A.Z. Sint-Blasius
  • Genk, Belgium
    • ZOL GENK
• Germany
  • Arnsberg, Germany
    • Klinikum Hochsauerland - Karolinen Hospital
  • Bad Krozingen, Germany
    • University Heart Center Freiburg - Bad Krozingen
  • Leipzig, Germany
    • University of Leipzig
• Italy
  • Abano Terme, Italy
    • Policlinico Abano Terme
  • Cotignola, Italy
    • Maria Cecilia Hospital
• Netherlands
  • Nieuwegein, Netherlands
    • St. Antonius Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Claudication; Subjects presenting with claudication, identified as Rutherford category 1, 2, or 3	Device: MicroStent; Treatment of arterial stenosis or occlusion with the MicroStent Perihperal Vascular Stent System
Critical Limb Ischemia; Subjects presenting with rest pain (Rutherford category 4) or minor tissue loss (Rutherford category 5)	Device: MicroStent; Treatment of arterial stenosis or occlusion with the MicroStent Perihperal Vascular Stent System
Critical Limb Ischemia with major tissue loss; Subjects presenting with major tissue loss (Rutherford 6)	Device: MicroStent; Treatment of arterial stenosis or occlusion with the MicroStent Perihperal Vascular Stent System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from 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.	6, 12, 24 Months
Freedom from Major Amputation	Freedom from above-ankle amputation in the target limb	6, 12, 24 Months
Freedom from Clinically Driven Target Lesion Revascularization (TLR)	Freedom from any revascularization procedure with involvement of the target lesion that is due to complaints of leg pain or worsening leg pain, a progressing, non-healing ulcer, or new ulcer formation with or without the presence of an abnormal non-invasive test.	6, 12, 24 Months
Wound Healing	Wounds will be identified at the baseline visit and classified as fully healed or not healed at each follow up visit.	30 days, 6, 12, 24 Months
Device Success	Operator assessment of successful device deployment and full coverage of the lesion as intended	Procedure
Technical Success	Attainment of less than or equal to 30% residual stenosis by visual estimate in the treated lesion using only the study device according to the IFU (i.e. including post dilation at the discretion of the investigator)	Procedure

Collaborators and Investigators

• Sponsor: Micro Medical Solution, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: September 27, 2019
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Estimated): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: CLI; MicroStent; Below the Knee; CLTI; Below the Ankle
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: MMS-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No