Peripheral Arterial DiseaseHEALNCT04110327
An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
An observational study of Peripheral Arterial Disease and Critical Lower Limb Ischemia, run by Micro Medical Solution, Inc. at 10 sites in 5 countries.
Trial summary
Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStent™ System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Critical Lower Limb Ischemia
- What is being tested?
- MicroStent
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 10 sitesin 5 countries
- Study dates
- 31 Oct 2019to 31 Dec 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include any subject with symptomatic peripheral arterial disease (PAD) that require intervention with the MicroStent™ System.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
Germany3 sites
Klinikum Hochsauerland - Karolinen Hospital
Arnsberg
University Heart Center Freiburg - Bad Krozingen
Bad Krozingen
University of Leipzig
Leipzig
Italy2 sites
Policlinico Abano Terme
Abano Terme
Maria Cecilia Hospital
Cotignola
About this study
Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStent™ System.
Read the 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.
- Being tested
- MicroStent
- Keywords
- MicroStent, Below the Knee, CLI, Below the Ankle, CLTI
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroStentDevice
Treatment of arterial stenosis or occlusion with the MicroStent Peripheral Vascular Stent System
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Patency
Freedom from target lesion occlusion with no clinically driven target lesion revascularization (TLR)
Measured: 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.
Measured: 30 days post-procedure
Secondary outcomes (6)
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.
Measured: 6, 12, 24 Months
Freedom from Major Amputation
Freedom from above-ankle amputation in the target limb
Measured: 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.
Measured: 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.
Measured: 30 days, 6, 12, 24 Months
Device Success
Operator assessment of successful device deployment and full coverage of the lesion as intended
Measured: 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)
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start31 Oct 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Micro Medical Solution, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110327
- Sponsor's protocol ID
- MMS-201
- Acronym
- HEAL
- Status last verified
- Jun 2026
- First submitted
- 27 Sep 2019
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT04110327
- Acronym / sponsor ID
- HEAL / MMS-201
- Keywords
- MicroStent, Below the Knee, CLI, Below the Ankle, CLTI
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Micro Medical Solution, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStent™ System.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include any subject with symptomatic peripheral arterial disease (PAD) that require intervention with the MicroStent™ System.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicroStentTreatment of arterial stenosis or occlusion with the MicroStent Peripheral Vascular Stent System | Device | – |
Primary outcome
Primary Patency
Time frame: 6 months post-procedure
Freedom from target lesion occlusion with no clinically driven target lesion revascularization (TLR)
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.
6 secondary outcomes
Freedom from Major Adverse Limb Events
Time frame: 6, 12, 24 Months
Freedom from Major Amputation
Time frame: 6, 12, 24 Months
Freedom from Clinically Driven Target Lesion Revascularization (TLR)
Time frame: 6, 12, 24 Months
Wound Healing
Time frame: 30 days, 6, 12, 24 Months
Device Success
Time frame: Procedure
Technical Success
Time frame: Procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Critical Lower Limb Ischemia, run by Micro Medical Solution, Inc. at 10 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Belgium, Germany, Italy, Austria, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Patency (time frame: 6 months post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.