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Active, not recruiting Not applicable

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

NCT03477604 · tracked via the Priya Life Science USA tracker
Sponsor
Micro Medical Solution, Inc
Phase
Not applicable
Started
2020-03-31
Last updated
2026-10-08

Condition(s) studied

Peripheral Arterial Disease

Investigational drug(s) / intervention(s)

MicroStent and Standard PTAStandard PTA

MicroStent and Standard PTA: Self-expanding stent and standard PTA balloon

Standard PTA: Standard PTA balloon

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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
General Inclusion Criteria: 1. Subject is a male or a non-pregnant female adult between the age of 21 and 90 years old. 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. Angiographic Inclusion Criteria 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. General Exclusion Criteria: 1. Subject had a prior or has a planned index limb amputation above the ankle. 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. Angiographic exclusion criteria 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.

Primary outcome measure(s)

  • Number of Subjects With Patency of the Target Lesion — up to 6 months after randomization
    Primary patency defined as freedom from target lesion occlusion with no clinically driven target lesion reintervention, or major amputation.
  • Number of Subjects With Freedom From Major Adverse Limb Event — up to 6 months after randomization
    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.

Trial sites (21)

FacilityCityRegionStatus
Cardiovascular Associates of the Southeast Birmingham Alabama
Copper State Vascular Mesa Arizona
St. Helena Hospital St. Helena California
Rocky Mountain Regional VA Medical Center Aurora Colorado
Palm Vascular Fort Lauderdale Florida
First Coast Cardiovascular Institute Jacksonville Florida
FHV Health Leesburg Florida
Mount Sinai Medical Center Miami Beach Florida
Advent Health Sebring Sebring Florida
Vascular Institute of the Midwest Davenport Iowa
Cardiovascular Institute of the South Houma Louisiana
University of Maryland - Baltimore Baltimore Maryland
Advanced Cardiac and Vascular Amputation Prevention Centers Grand Rapids Michigan
Deborah Heart and Lung Center Browns Mills New Jersey
North Jersey Vascular Center Clifton New Jersey
AMI Vascular Institute Galloway New Jersey
US Cardiovascular Jefferson Hills Pennsylvania
Brown University Providence Rhode Island
Cardiology Consultants Spartanburg South Carolina
Cardiothoracic and Vascular Surgeons Austin Texas
Third Coast Vascular Sheboygan Wisconsin
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03477604 on ClinicalTrials.gov ↗ ← All trials in the USA