Active, not recruitingNCT03477604STANDUpdated Oct 8, 2026Results posted

A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)

An interventional study of MicroStent and Standard PTA and Standard PTA in Peripheral Arterial Disease, sponsored by Micro Medical Solution, Inc.. Active, not recruiting at 21 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Micro Medical Solution, Inc. · Not applicable, Interventional, and Treatment

Updated Oct 8, 2026Results postedStudy documents posted+3 moreGo to Updates ↓

Phase: Not applicable
Study type: Interventional
Enrollment: 177
Allocation: Randomized
Ages: 21 Years and older
Sex: All

Where this study stands

Counted across the records on this site · 2026-11-12

Among 479 studies in Peripheral Arterial Disease with a site in United States — 82 open to participants now, 101 under way, 10 of them phase 3. Peripheral Arterial Disease · United States.

Enrollment: 90th of 373; 177 · median 64
Started: 2020; with 28 others
No phase: 217 of 479; 40 open now
Primary completion: 2025-06; later than 11 of 100 live
Registered: 273rd of 479; by date

Among the 479 studies in Peripheral Arterial Disease with a site in United States, this one is the 90th largest by enrollment of the 373 interventional ones that give a count, is one of 29 that started in 2020, is one of 217 with no phase, reaches primary completion later than 11 of the 100 other live ones, and was the 273rd registered.

Peripheral Arterial Disease

1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.

Browse Peripheral Arterial Disease studies →

Open to participants now

82 of the 479 studies in Peripheral Arterial Disease with a site in United States are open now. Recruiting first, the newest first:

RecruitingPhase 3NCT07318610
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Regeneron Pharmaceuticals · Sites in United States, United Kingdom
RecruitingPhase 1NCT07619885
The Pharmacokinetics and Pharmacodynamics Study of Evategrel CG-0255 Besylate）and Plavix® in Healthy Participants
Shanghai CureGene Pharmaceutical Co., Ltd. · Sites in United States
RecruitingNCT07223437
REVASC-PAD: REstricted VASCular Exercise for Peripheral Arterial Disease - A Feasibility Study at University of Tennessee Medical Center
University of Tennessee Graduate School of Medicine · Sites in United States
RecruitingNCT07144150
EVERO Drug-coated Balloon (DCB) Randomized Trial
Cook Research Incorporated · Sites in United States
RecruitingNCT07226193
Detecting Peripheral Artery Disease With the Pulse
University of Nebraska · Sites in United States

77 more — sign in →

All 82 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 192 Peripheral Arterial Disease studies recruiting now, 138 (72%) set no upper age limit and 9 (5%) stop at 75 or younger; 13 take children under 18; 19 take healthy volunteers.

This study: 21 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Who runs the 479 studies in Peripheral Arterial Disease with a site in United States

189 of 479 have an industry lead sponsor. The 10 most frequent:

Northwestern University25 · 7 open

VA Office of Research and Development16 · 5 open

University of Nebraska11 · 4 open

Medtronic Endovascular9 · 1 open · industry

University of California, San Francisco9

University of Oklahoma8 · 2 open

University of Virginia8 · 3 open

Abbott Medical Devices7 · industry

Indiana University7 · 1 open

National Heart, Lung, and Blood Institute (NHLBI)7

Micro Medical Solution, Inc. in Peripheral Arterial Disease

Micro Medical Solution, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Micro Medical Solution, Inc. has 2 studies filed under Peripheral Arterial Disease — fewer than ten, so there is no comparison to draw.

Its Peripheral Arterial Disease studies →

Coming up

36 of the studies in Peripheral Arterial Disease with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:

Study	Primary completion
NCT04794530Phase 3Northwestern UniversityThe COCOA-PAD II Trial	2026-12-31
NCT05132439Phase 3VA Office of Research and DevelopmentMetfOrmin BenefIts Lower Extremities With Intermittent Claudication	2027-02-28
NCT07639853Medtronic EndovascularCase-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils	2026-11
NCT06321575Nipro Vascular Innovations Americas, IncThe Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)	2026-11
NCT06399809Northwestern UniversityFisetin to Reduce Senescence and Mobility Impairment in PAD	2026-11

All 36 — sign in →

What changed since 2026-09-25

Among the 479 studies in Peripheral Arterial Disease with a site in United States, from their registry updates:

Newly registered 1

NCT079194832026-11-05Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study

Stopped 1

NCT073363812026-10-29WITHDRAWNShortwave Diathermy In-home Treatment for Indianapolis VA-only Patients Diagnosed With Peripheral Artery Disease and Peripheral Neuropathy

Results posted 2

NCT043718612026-10-22Observational Study to Assess Transradial Access for Treatment in the Lower Extremities.
NCT034776042026-10-08A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)

Primary completion moved 11

NCT039952382026-11-102026-10-31 → 2026-09-01Optimizing Gait Rehabilitation for Veterans With Non-traumatic Lower Limb Amputation
NCT048891052026-11-102026-10-30 → 2026-10-26Exercise Therapy for PAD Using Mobile Health
NCT073353412026-11-062026-10 → 2026-10-30Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System
NCT051323612026-11-042026-06-24 → 2026-07-25SELUTION4SFA Trial
NCT076542312026-11-042027-12-01 → 2029-05-01REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial

6 more — sign in →

This tab as a report to print or save as PDF → With an account.

Watch this landscape Download CSV Narrow it in search →With an account: a weekly mail of what changed among 479 studies in Peripheral Arterial Disease with a site in United States, or all of them as a file.

Study summary

Randomized multicenter clinical trial consisting of two arms; one arm treated with PTA plus the MicroStent® System and one arm treated with PTA alone. Purpose to evaluate the safety and effectiveness of using the MicroStent® Peripheral Vascular Stent System, hereafter referred to as the MicroStent® System, for the treatment of infrapopliteal lesions in subjects with peripheral arterial disease.

Conditions studied

Peripheral Arterial Disease

Browse trials for

Peripheral Arterial Disease 1,377

Keywords

Below the knee
Stent

Who can participate

Ages eligible: 21 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

General Inclusion Criteria:

Subject is a male or a non-pregnant female adult between the age of 21 and 90 years old.
Subject has documented clinical evidence of critical limb ischemia (CLI) in the target limb prior to the index procedure, with a Rutherford Classification score of 4-5.
The subject, or subject's designated legal representative, has been informed of the nature of the study and is willing to provide written .
Subject is willing to comply with all required follow-up visits.
Subject is ≥1 year per the Principal Investigator.
Angiographic Inclusion Criteria
Target vessel reconstitutes at or above the ankle with inline flow to at least one patent (\<50% stenosis) inframalleolar outflow vessel.
Subject has a lesion, with ≥ 70% stenosis and ≤ 12.0 cm in length located at or distal to the tibial-peroneal trunk and above the tibiotalar joint; including the anterior tibial, posterior tibial or peroneal arteries.
Target lesion has a reference vessel diameter of 2.5 - 4.5 mm
The target lesion is able to be crossed with a guidewire to facilitate treatment with the randomized device.

General Exclusion Criteria:

Subject had a prior or has a planned index limb amputation above the ankle.
Subject has a wound/ulcer on the forefoot with a surface area >4cm² or osteomyelitis involving the calcaneus bone.
Subject is pregnant, plans to become pregnant, or is nursing.
Subject has clinical conditions that severely inhibit X-ray or duplex ultrasound visualization (e.g. body habitus).
Subject has a history of hypercoagulation/clotting disorders or acute thrombosis.
Subject has allergy to iodinated contrast media that cannot be adequately managed with medication.
Subject is in acute renal failure.
Subject has an active systemic infection.
Subject is participating in another research study involving an device, biologic, or drug that has not completed the primary endpoint at the time of randomization/enrollment.
Subject has other comorbidities that - in the opinion of the investigator - preclude them from receiving study treatment and/or from completing the required study follow-up assessments.
Subject presents with acute limb ischemia or acute thrombosis of the target limb.
Subject has experienced myocardial infarction, thrombolysis, or angina less than 30 days prior to the index procedure.
Subject had a stroke within 3 months of index procedure.
Angiographic exclusion criteria
Failure to successfully treat inflow lesions in the ipsilateral iliac, femoral, or popliteal arteries. Successful treatment is defined as obtaining ≤30% residual stenosis with no major procedural complications (e.g embolism).
Failure to successfully treat significant non-target infra-popliteal lesions. Successful treatment is defined as obtaining ≤30% residual stenosis with no major procedural complications (e.g. embolism).
Target lesion is within a previously placed stent.

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 177 participants (actual)

Study arms

Experimental
MicroStent and Standard PTA
Implant of the MicroStent peripheral vascular stent system for treatment of arterial lesions below the knee.
Device: MicroStent and Standard PTA
Active comparator
Standard PTA
Device: Standard PTA

Interventions

DeviceMicroStent and Standard PTA
Self-expanding stent and standard PTA balloon
DeviceStandard PTA
Standard PTA balloon

What researchers measure

Primary outcomes

Number of Subjects With Patency of the Target Lesion
Primary patency defined as freedom from target lesion occlusion with no clinically driven target lesion reintervention, or major amputation.
Time frame: up to 6 months after randomization
Number of Subjects With Freedom From Major Adverse Limb Event
Freedom from MALE defined as the number of subjects who did not experience a major amputation (above the ankle) or a major reintervention (new or revised graft, thrombectomy, thrombolysis) involving the target lesion.
Time frame: up to 6 months after randomization

Secondary outcomes

Number of Subjects With Freedom From Major Amputation Above the Ankle
Freedom from major amputation (above the ankle)
Time frame: up to 6 months after randomization
Number of Subjects With Freedom From Major Adverse Limb Event
Freedom from major adverse limb event
Time frame: From date of randomization up to 12 months
Number of Subjects With Reduction in Size of Ischemic Leg/Foot Ulcers
Reduction in size of ischemic leg/foot ulcers
Time frame: up to 6 months after randomization
Frequency and Severity of Serious Adverse Events Related to Device.
Frequency and severity of serious adverse events related to device.
Time frame: From date of randomization until the date of death from any cause assessed up to 12 months
Frequency and Severity of Serious Adverse Events Related to Procedure.
Frequency and severity of serious adverse events related to procedure.
Time frame: From date of randomization until date of death from any cause assessed up to 12 months.

Results

Posted Oct 8, 2026

Limitations and caveats

Limitations of the study include the loss of subjects in follow up associated with the high-risk comorbidities of the population. Follow up of this study population was challenged during COVID as the study was initiated during this time. This limited subjects' ability to be treated and followed in the study. The study had a volume of Duplex Ultrasound imaging noncompliance however; clinical visit compliance was satisfactory to assess the subjects for study outcomes.

Participant flow

STAND is a prospective, multicenter, randomized (2:1) trial conducted at 21 sites in the United States. The trial randomized 177 subjects with chronic limb-threatening ischemia (CLTI) and infrapopliteal disease between March 31, 2020 and December 5, 2023, with 117 subjects enrolled to the MicroStent arm and 60 subjects enrolled to the percutaneous transluminal angioplasty (PTA) arm. 1 PTA subject was prematurely enrolled prior to angiographic exclusion criteria and was withdrawn.

Participant flow — Overall Study
Milestone	MicroStent and Standard PTA	Standard PTA
Started	117	60
Completed	40	17
Not completed	77	43

Outcome measures

PrimaryNumber of Subjects With Patency of the Target Lesion

Primary patency defined as freedom from target lesion occlusion with no clinically driven target lesion reintervention, or major amputation.

Time frame:: up to 6 months after randomization
Reported as:: Count of participants · Participants

Number of Subjects With Patency of the Target Lesion
Participants	PTA + MicroStent and Standard PTA	Standard PTA
Number of Subjects With Patency of the Target Lesion	98	44

PrimaryNumber of Subjects With Freedom From Major Adverse Limb Event

Freedom from MALE defined as the number of subjects who did not experience a major amputation (above the ankle) or a major reintervention (new or revised graft, thrombectomy, thrombolysis) involving the target lesion.

Time frame:: up to 6 months after randomization
Reported as:: Count of participants · Participants

Number of Subjects With Freedom From Major Adverse Limb Event
Participants	MicroStent and Standard PTA	Standard PTA
Number of Subjects With Freedom From Major Adverse Limb Event	114	59

SecondaryNumber of Subjects With Freedom From Major Amputation Above the Ankle

Freedom from major amputation (above the ankle)

Time frame:: up to 6 months after randomization
Reported as:: Count of participants · Participants

Number of Subjects With Freedom From Major Amputation Above the Ankle
Participants	MicroStent and Standard PTA	Standard PTA
Number of Subjects With Freedom From Major Amputation Above the Ankle	98	50

SecondaryNumber of Subjects With Freedom From Major Adverse Limb Event

Freedom from major adverse limb event

Time frame:: From date of randomization up to 12 months
Reported as:: Count of participants · Participants

Number of Subjects With Freedom From Major Adverse Limb Event
Participants	MicroStent and Standard PTA	Standard PTA
Number of Subjects With Freedom From Major Adverse Limb Event	113	59

SecondaryNumber of Subjects With Reduction in Size of Ischemic Leg/Foot Ulcers

Reduction in size of ischemic leg/foot ulcers

Time frame:: up to 6 months after randomization
Reported as:: Count of participants · Participants

Number of Subjects With Reduction in Size of Ischemic Leg/Foot Ulcers
Participants	MicroStent and Standard PTA	Standard PTA
Number of Subjects With Reduction in Size of Ischemic Leg/Foot Ulcers	15	4

SecondaryFrequency and Severity of Serious Adverse Events Related to Device.

Frequency and severity of serious adverse events related to device.

Time frame:: From date of randomization until the date of death from any cause assessed up to 12 months
Reported as:: Count of participants · Participants

Frequency and Severity of Serious Adverse Events Related to Device.
Participants	MicroStent and Standard PTA	Standard PTA
Frequency and Severity of Serious Adverse Events Related to Device.	2	0

SecondaryFrequency and Severity of Serious Adverse Events Related to Procedure.

Frequency and severity of serious adverse events related to procedure.

Time frame:: From date of randomization until date of death from any cause assessed up to 12 months.
Reported as:: Count of participants · Participants

Frequency and Severity of Serious Adverse Events Related to Procedure.
Participants	MicroStent and Standard PTA	Standard PTA
Frequency and Severity of Serious Adverse Events Related to Procedure.	97	51

Adverse events

Collected over From enrollment through 12 months of follow up. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
MicroStent and Standard PTA	86/116 (74.1%)	86/116 (74.1%)	74/116 (63.8%)
Standard PTA	43/60 (71.7%)	43/60 (71.7%)	31/60 (51.7%)

Most frequent serious events

Showing 10 of 19

Most frequent serious events
Event	MicroStent and Standard PTA	Standard PTA
Vascular disordersVascular disorders	54/116	31/60
Cardiac DisordersCardiac disorders	27/116	9/60
Infections and infestationsInfections and infestations	22/116	12/60
Nervous system disordersNervous system disorders	13/116	9/60
Musculoskeletal and connective tissue disordersMusculoskeletal and connective tissue disorders	16/116	7/60
Injury, poisoning and procedural complicationsInjury, poisoning and procedural complications	15/116	3/60
Surgical and medical proceduresSurgical and medical procedures	11/116	5/60
Skin and subcutaneous tissue disordersSkin and subcutaneous tissue disorders	10/116	5/60
Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders	4/116	5/60
Gastrointestinal disordersGastrointestinal disorders	7/116	2/60

Most frequent other events

Showing 10 of 21

Most frequent other events
Event	MicroStent and Standard PTA	Standard PTA
Vascular disordersVascular disorders	41/116	14/60
Musculoskeletal and connective tissue disordersMusculoskeletal and connective tissue disorders	22/116	11/60
Injury, poisoning and procedural complicationsInjury, poisoning and procedural complications	21/116	9/60
Infections and infestationsInfections and infestations	12/116	4/60
Skin and subcutaneous tissue disordersSkin and subcutaneous tissue disorders	11/116	4/60
General disorders and administration site conditionsGeneral disorders	9/116	4/60
Nervous system disordersNervous system disorders	8/116	4/60
Renal and urinary disordersRenal and urinary disorders	7/116	2/60
Cardiac DisordersCardiac disorders	5/116	3/60
Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders	5/116	3/60

Baseline characteristics

Intent to treat population

Age, Continuous
Age, Continuous(Years)	MicroStent and Standard PTA	Standard PTA	Total
Mean	70.9 ± 10.5	73.9 ± 9.0	72.4 ± 9.75

Sex: Female, Male
Sex: Female, Male(Participants)	MicroStent and Standard PTA	Standard PTA	Total
Female	33	26	59
Male	84	33	117

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	MicroStent and Standard PTA	Standard PTA	Total
American Indian or Alaska Native	1	1	2
Asian	2	0	2
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	11	8	19
White	93	45	138
More than one race	1	0	1
Unknown or Not Reported	9	5	14

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	MicroStent and Standard PTA	Standard PTA	Total
Hispanic or Latino	23	9	32
Not Hispanic or Latino	82	46	128
Unknown or Not Reported	12	4	16

Study locations

21 sites

Cardiovascular Associates of the Southeast
Birmingham, Alabama 35243, United States
1 other open study at this site →
Copper State Vascular
Mesa, Arizona 85203, United States
St. Helena Hospital
St. Helena, California 94574, United States
Rocky Mountain Regional VA Medical Center
Aurora, Colorado 80045, United States
53 other open studies at this site →
Palm Vascular
Fort Lauderdale, Florida 33312, United States
First Coast Cardiovascular Institute
Jacksonville, Florida 32256, United States
10 other open studies at this site →
FHV Health
Leesburg, Florida 34748, United States
Mount Sinai Medical Center
Miami Beach, Florida 33140, United States
46 other open studies at this site →
Advent Health Sebring
Sebring, Florida 33872, United States
Vascular Institute of the Midwest
Davenport, Iowa 52807, United States
3 other open studies at this site →
Cardiovascular Institute of the South
Houma, Louisiana 70360, United States
18 other open studies at this site →
University of Maryland - Baltimore
Baltimore, Maryland 21201, United States
42 other open studies at this site →
Advanced Cardiac and Vascular Amputation Prevention Centers
Grand Rapids, Michigan 49525, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey 08015, United States
7 other open studies at this site →
North Jersey Vascular Center
Clifton, New Jersey 07013, United States
AMI Vascular Institute
Galloway, New Jersey 08205, United States
US Cardiovascular
Jefferson Hills, Pennsylvania 15025, United States
Brown University
Providence, Rhode Island 02904, United States
52 other open studies at this site →
Cardiology Consultants
Spartanburg, South Carolina 29303, United States
Cardiothoracic and Vascular Surgeons
Austin, Texas 78756, United States
2 other open studies at this site →
Third Coast Vascular
Sheboygan, Wisconsin 53801, United States

References and documents

Study documents

Study protocol ↗ · Aug 19, 2022
Statistical analysis plan ↗ · Dec 23, 2025

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

1 registry update since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2020 to primary completion in Jun 2025, 62 months.

Results were first posted in Oct 2026, 1 year 4 months after primary completion.

Of 125 industry-sponsored interventional studies with no phase under Peripheral Arterial Disease, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 45. This study's 62 months is above that.

Counting every sponsor, half of 385 studies reached it within 31 months; a quarter within 17 and three quarters within 55.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 8, 2018
First posted: Mar 26, 2018
StartActual: Mar 31, 2020
Primary completionActual: Jun 5, 2025
CompletionEst.: Mar 2028
Results first posted: Oct 8, 2026
Last update: Oct 8, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

Results

Results posted

posted Oct 8, 2026

Sites

1 site added, 1 site removed

Show site

Third Coast Vascular · Sheboygan, United States

Show 1 removed

AZH/WAVE Vascular Center · Milwaukee, United States

Oct 8, 2026

Primary outcomes

2 edited, 1 removed

What changed in the outcomes

EditedNumber of Subjects With Patency of the ~~target lesion~~Target LesionTime frame: up to 6 months after randomization
EditedNumber of Subjects With Freedom ~~from major adverse limb event~~From Major Adverse Limb EventTime frame: up to 6 months after randomization
Removed~~Freedom from perioperative death~~Time frame: up to 30 days after randomization

Oct 8, 2026

Documents

Study protocol ↗ posted · Statistical analysis plan ↗ posted

Oct 8, 2026

Secondary outcomes

4 edited, 1 added

What changed in the outcomes

EditedNumber of Subjects With Freedom ~~from major amputation above~~From Major Amputation Above the ~~ankle~~AnkleTime frame: up to 6 months after randomization
EditedNumber of Subjects With Reduction in ~~size~~Size of ~~ischemic leg~~Ischemic Leg/~~foot ulcers~~Foot UlcersTime frame: up to 6 months after randomization
EditedNumber of Subjects With Freedom ~~from major adverse limb event~~From Major Adverse Limb EventTime frame: ~~From date of randomization until the date of death from any cause assessed up to 36 months~~ → From date of randomization up to 12 months
EditedFrequency and ~~severity~~Severity of ~~serious adverse events and device and procedure related adverse events~~Serious Adverse Events Related to Device.Time frame: ~~From date of randomization until the date of death from any cause assessed up to 36 months~~ → From date of randomization until the date of death from any cause assessed up to 12 months
AddedFrequency and Severity of Serious Adverse Events Related to Procedure.Time frame: From date of randomization until date of death from any cause assessed up to 12 months.

Oct 8, 2026

Show all 1 update

Oct 8, 2026
Results posted
Documents Study protocol ↗ posted · Statistical analysis plan ↗ posted
1 site added, 1 site removed
Show site
- Third Coast Vascular · Sheboygan, United States
Show 1 removed
- AZH/WAVE Vascular Center · Milwaukee, United States
Primary outcomes 2 edited, 1 removed
What changed in the outcomes
- EditedNumber of Subjects With Patency of the ~~target lesion~~Target LesionTime frame: up to 6 months after randomization
- EditedNumber of Subjects With Freedom ~~from major adverse limb event~~From Major Adverse Limb EventTime frame: up to 6 months after randomization
- Removed~~Freedom from perioperative death~~Time frame: up to 30 days after randomization
Secondary outcomes 4 edited, 1 added
What changed in the outcomes
- EditedNumber of Subjects With Freedom ~~from major amputation above~~From Major Amputation Above the ~~ankle~~AnkleTime frame: up to 6 months after randomization
- EditedNumber of Subjects With Reduction in ~~size~~Size of ~~ischemic leg~~Ischemic Leg/~~foot ulcers~~Foot UlcersTime frame: up to 6 months after randomization
- EditedNumber of Subjects With Freedom ~~from major adverse limb event~~From Major Adverse Limb EventTime frame: ~~From date of randomization until the date of death from any cause assessed up to 36 months~~ → From date of randomization up to 12 months
- EditedFrequency and ~~severity~~Severity of ~~serious adverse events and device and procedure related adverse events~~Serious Adverse Events Related to Device.Time frame: ~~From date of randomization until the date of death from any cause assessed up to 36 months~~ → From date of randomization until the date of death from any cause assessed up to 12 months
- AddedFrequency and Severity of Serious Adverse Events Related to Procedure.Time frame: From date of randomization until date of death from any cause assessed up to 12 months.
+ 3 other changes: identifiers, verification date and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03477604
Lead sponsor: Micro Medical Solution, Inc.
Responsible party: Sponsor
First posted: Mar 26, 2018
Start date: Mar 31, 2020
Primary completion: Jun 5, 2025
Completion: Mar 2028 (estimated)
Results posted: Oct 8, 2026
Last update: Oct 8, 2026

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Peripheral Arterial Disease →

Other studies from this sponsor

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An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial DiseaseActive, not recruitingNCT04110327

Start the discussion

A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)

Where this study stands

Peripheral Arterial Disease

Open to participants now

Who these studies take

By phase

By the year they started

What they test

Size and results

Who runs the 479 studies in Peripheral Arterial Disease with a site in United States

Micro Medical Solution, Inc. in Peripheral Arterial Disease

Coming up

What changed since 2026-09-25

Newly registered 1

Stopped 1

Results posted 2

Primary completion moved 11

Study summary

Conditions studied

Browse trials for

Keywords

Who can participate

Eligibility criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Study documents

Individual participant data

Timeline

Registry details

Key details

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor