Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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: NCT04025008
Recruitment Status : Not yet recruiting
First Posted : July 18, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Micro Medical Solution, Inc.

Brief Summary:
This prospective pivotal study is a double arm, randomized multi-center study evaluating the safety and performance of the MicroStent peripheral vascular stent system for use in arterial lesions below the knee. A total of 177 subjects will be enrolled at up to 25 centers and followed for up to 3 years, with the primary safety and efficacy endpoints evaluated 30 days and 6 months, respectively, post-implant.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: MicroStent or percutaneous transluminal angioplasty (PTA) Not Applicable

Layout table for study information
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)
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : August 2021

Arm Intervention/treatment
Active Comparator: Control Arm - percutaneous transluminal angioplasty (PTA) Device: MicroStent or percutaneous transluminal angioplasty (PTA)
Intravascular treatment

Experimental: Investigational Device - MicroStent Device: MicroStent or percutaneous transluminal angioplasty (PTA)
Intravascular treatment




Primary Outcome Measures :
  1. Freedom from perioperative death (POD) [ Time Frame: 30 days post index procedure ]
    Primary Safety Endpoint

  2. Freedom from major adverse limb event (MALE) [ Time Frame: 6 months post index procedure ]
    Primary Safety Endpoint

  3. Freedom from major amputation [ Time Frame: 6 months post index procedure ]
    Primary Effectiveness Endpoint

  4. Freedom from target lesion occlusion with no clinically driven target lesion reintervention (TLR) [ Time Frame: 6 months post index procedure ]
    Primary Effectiveness Endpoint


Secondary Outcome Measures :
  1. Freedom from major adverse limb event (MALE) [ Time Frame: 30 days, 3 months, 6 months, 1 year, 2 year, and 3 years post index procedure ]
    Secondary Safety Endpoint #1

  2. Frequency and severity of serious adverse events and device and procedure-related adverse events. [ Time Frame: Post randomization, 30 days, 3 months, 6 months, 1 year, 2 year, and 3 years post randomization ]
    Secondary Safety Endpoint #2

  3. Freedom from major amputation (above the ankle) [ Time Frame: 6 months post index procedure ]
    Secondary Effectiveness Endpoint #1

  4. Reduction in size of ischemic leg/foot ulcers [ Time Frame: 6 months post index procedure ]
    Secondary Effectiveness Endpoint #2



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 90 Years   (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): NCT04025008


Contacts
Layout table for location contacts
Contact: Kate Mandall (949) 292-5466 kmandall@micromedicalsolutions.net

  Show 19 Study Locations
Sponsors and Collaborators
Micro Medical Solution, Inc.

Layout table for additonal information
Responsible Party: Micro Medical Solution, Inc.
ClinicalTrials.gov Identifier: NCT04025008     History of Changes
Other Study ID Numbers: MMS-001-B
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Sharing IPD is not in the scope of the study informed consent.

Layout table for additional information
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
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases