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NCT Number: NCT04110327

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Univ.-Klinikum LKH Graz, Graz, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

MicroStent

Device

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

Primary outcomes

  1. Primary Patency

    Time frame: 6 months post-procedure

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

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

    Time frame: 30 days post-procedure

    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.

Secondary outcomes

  1. Freedom from Major Adverse Limb Events

    Time frame: 6, 12, 24 Months

    Major adverse limb events include above-ankle amputation, new bypass graft or graft revision, and thrombectomy or thrombolysis involving the target lesion.

  2. Freedom from Major Amputation

    Time frame: 6, 12, 24 Months

    Freedom from above-ankle amputation in the target limb

  3. Freedom from Clinically Driven Target Lesion Revascularization (TLR)

    Time frame: 6, 12, 24 Months

    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.

  4. Wound Healing

    Time frame: 30 days, 6, 12, 24 Months

    Wounds will be identified at the baseline visit and classified as fully healed or not healed at each follow up visit.

  5. Device Success

    Time frame: Procedure

    Operator assessment of successful device deployment and full coverage of the lesion as intended

  6. Technical Success

    Time frame: Procedure

    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)

Sponsors and collaborators

Lead sponsor

Micro Medical Solution, Inc.

Industry

Registry information

Acronym: HEAL

Important dates

Study start
2019
Primary completion
2026
Study completion
2028
First posted
Oct 1, 2019
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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