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

October 3, 2022 updated by: Micro Medical Solution, Inc.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

177

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • Recruiting
        • Cardiovascular Associates of the Southeast
        • Contact:
        • Principal Investigator:
          • Jan Skowronski, MD
    • Arizona
      • Mesa, Arizona, United States, 85203
    • California
      • Saint Helena, California, United States, 94574
        • Recruiting
        • St. Helena Hospital
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Active, not recruiting
        • Rocky Mountain Regional VA Medical Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33312
        • Recruiting
        • Palm Vascular
        • Principal Investigator:
          • Robert Beasley, MD
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • First Coast Cardiovascular Institute
        • Contact:
        • Principal Investigator:
          • Vaquar Ali, MD
      • Leesburg, Florida, United States, 34748
      • Miami Beach, Florida, United States, 33140
        • Active, not recruiting
        • Mount Sinai Medical Center
      • Sebring, Florida, United States, 33872
        • Active, not recruiting
        • Advent Health Sebring
    • Iowa
      • Davenport, Iowa, United States, 52807
        • Recruiting
        • Vascular Institute of the Midwest
        • Contact:
        • Principal Investigator:
          • Eric Dippel, MD
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Recruiting
        • Cardiovascular Institute of the South
        • Contact:
        • Principal Investigator:
          • Craig Walker, MD
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland - Baltimore
        • Contact:
        • Principal Investigator:
          • Khanjan Nagarsheth, MD
    • Michigan
      • Grand Rapids, Michigan, United States, 49525
        • Recruiting
        • Advanced Cardiac and Vascular Amputation Prevention Centers
        • Contact:
        • Principal Investigator:
          • Fadi Saab, MD
      • Roseville, Michigan, United States, 48066
        • Active, not recruiting
        • Eastlake Cardiovascular
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Active, not recruiting
        • Deborah Heart and Lung Center
      • Clifton, New Jersey, United States, 07013
        • Active, not recruiting
        • North Jersey Vascular Center
      • Galloway, New Jersey, United States, 08205
        • Recruiting
        • AMI Vascular Institute
        • Contact:
        • Principal Investigator:
          • Nicholas Petruzzi, MD
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Withdrawn
        • NC Heart and Vascular Research
    • Pennsylvania
      • Jefferson Hills, Pennsylvania, United States, 15025
        • Recruiting
        • US Cardiovascular
        • Contact:
        • Principal Investigator:
          • Gennady Geskin, MD
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Recruiting
        • Brown University
        • Principal Investigator:
          • Peter Soukas, MD
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Cardiology Consultants
        • Contact:
        • Principal Investigator:
          • Brian Brown, MD
    • Texas
      • Austin, Texas, United States, 78756
        • Recruiting
        • Cardiothoracic and Vascular Surgeons
        • Contact:
        • Principal Investigator:
          • David Nation, MD
      • Tyler, Texas, United States, 75701
        • Withdrawn
        • Cardiovascular Associates of East Texas
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53221
        • Recruiting
        • AZH/WAVE Vascular Center
        • Contact:
        • Principal Investigator:
          • Awais Siddique, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Self-expanding stent and standard PTA balloon
Active Comparator: Standard PTA
Device: Standard PTA
Standard PTA balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patency of the target lesion
Time Frame: 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.
up to 6 months after randomization
Freedom from perioperative death
Time Frame: up to 30 days after randomization
Freedom from perioperative death
up to 30 days after randomization
Freedom from major adverse limb event
Time Frame: up to 6 months after randomization
Freedom from major adverse limb event
up to 6 months after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from major amputation above the ankle
Time Frame: up to 6 months after randomization
Freedom from major amputation (above the ankle)
up to 6 months after randomization
Reduction in size of ischemic leg/foot ulcers
Time Frame: up to 6 months after randomization
Reduction in size of ischemic leg/foot ulcers
up to 6 months after randomization
Freedom from major adverse limb event
Time Frame: From date of randomization until the date of death from any cause assessed up to 36 months
Freedom from major adverse limb event
From date of randomization until the date of death from any cause assessed up to 36 months
Frequency and severity of serious adverse events and device and procedure related adverse events
Time Frame: From date of randomization until the date of death from any cause assessed up to 36 months
Frequency and severity of serious adverse events and device and procedure-related adverse events at any time during the study.
From date of randomization until the date of death from any cause assessed up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Micro Medical Solution, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2019

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 1, 2026

Study Registration Dates

First Submitted

March 8, 2018

First Submitted That Met QC Criteria

March 19, 2018

First Posted (Actual)

March 26, 2018

Study Record Updates

Last Update Posted (Actual)

October 4, 2022

Last Update Submitted That Met QC Criteria

October 3, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMS-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Peripheral Arterial Disease

Clinical Trials on MicroStent and Standard PTA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe