A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)
NCT ID: NCT03477604
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
177 participants
INTERVENTIONAL
2020-03-31
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MicroStent and Standard PTA
Implant of the MicroStent peripheral vascular stent system for treatment of arterial lesions below the knee.
MicroStent and Standard PTA
Self-expanding stent and standard PTA balloon
Standard PTA
Standard PTA
Standard PTA balloon
Interventions
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MicroStent and Standard PTA
Self-expanding stent and standard PTA balloon
Standard PTA
Standard PTA balloon
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. The subject, or subject's designated legal representative, has been informed of the nature of the study and is willing to provide written informed consent.
4. Subject is willing to comply with all required follow-up visits.
5. Subject life expectancy is ≥1 year per the Principal Investigator.
6. Target vessel reconstitutes at or above the ankle with inline flow to at least one patent (\<50% stenosis) inframalleolar outflow vessel.
7. 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.
8. Target lesion has a reference vessel diameter of 2.5 - 4.5 mm
9. The target lesion is able to be crossed with a guidewire to facilitate treatment with the randomized device.
Exclusion Criteria
2. Subject has a wound/ulcer on the forefoot with a surface area \>4cm² or osteomyelitis involving the calcaneus bone.
3. Subject is pregnant, plans to become pregnant, or is nursing.
4. Subject has clinical conditions that severely inhibit X-ray or duplex ultrasound visualization (e.g. body habitus).
5. Subject has a history of hypercoagulation/clotting disorders or acute thrombosis.
6. Subject has allergy to iodinated contrast media that cannot be adequately managed with medication.
7. Subject is in acute renal failure.
8. Subject has an active systemic infection.
9. Subject is participating in another research study involving an investigational device, biologic, or drug that has not completed the primary endpoint at the time of randomization/enrollment.
10. 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.
11. Subject presents with acute limb ischemia or acute thrombosis of the target limb.
12. Subject has experienced myocardial infarction, thrombolysis, or angina less than 30 days prior to the index procedure.
13. Subject had a stroke within 3 months of index procedure.
14. Failure to successfully treat clinically significant 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).
15. 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).
16. Target lesion is within a previously placed stent.
21 Years
ALL
No
Sponsors
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Micro Medical Solution, Inc.
INDUSTRY
Responsible Party
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Locations
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Cardiovascular Associates of the Southeast
Birmingham, Alabama, United States
Copper State Vascular
Mesa, Arizona, United States
St. Helena Hospital
St. Helena, California, United States
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, United States
Palm Vascular
Fort Lauderdale, Florida, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
FHV Health
Leesburg, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Advent Health Sebring
Sebring, Florida, United States
Vascular Institute of the Midwest
Davenport, Iowa, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
University of Maryland - Baltimore
Baltimore, Maryland, United States
Advanced Cardiac and Vascular Amputation Prevention Centers
Grand Rapids, Michigan, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
North Jersey Vascular Center
Clifton, New Jersey, United States
AMI Vascular Institute
Galloway, New Jersey, United States
US Cardiovascular
Jefferson Hills, Pennsylvania, United States
Brown University
Providence, Rhode Island, United States
Cardiology Consultants
Spartanburg, South Carolina, United States
Cardiothoracic and Vascular Surgeons
Austin, Texas, United States
AZH/WAVE Vascular Center
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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MMS-001
Identifier Type: -
Identifier Source: org_study_id
NCT04025008
Identifier Type: -
Identifier Source: nct_alias