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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03477604
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Micro Medical Solution, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: MicroStent and Standard PTA Device: Standard PTA Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 177 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)
Actual Study Start Date : June 19, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. Freedom from perioperative death [ Time Frame: up to 30 days after randomization ]
    Freedom from perioperative death

  3. Freedom from major adverse limb event [ Time Frame: up to 6 months after randomization ]
    Freedom from major adverse limb event


Secondary Outcome Measures :
  1. Freedom from major amputation above the ankle [ Time Frame: up to 6 months after randomization ]
    Freedom from major amputation (above the ankle)

  2. Reduction in size of ischemic leg/foot ulcers [ Time Frame: up to 6 months after randomization ]
    Reduction in size of ischemic leg/foot ulcers

  3. 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

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03477604


Contacts
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Contact: Kate Mandall 949-292-5466 kmandall@micromedicalsolutions.net

Locations
Show Show 19 study locations
Sponsors and Collaborators
Micro Medical Solution, Inc.
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Responsible Party: Micro Medical Solution, Inc.
ClinicalTrials.gov Identifier: NCT03477604    
Obsolete Identifiers: NCT04025008
Other Study ID Numbers: MMS-001
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Micro Medical Solution, Inc.:
Below the knee
Stent
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases