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A Clinical Feasibility Evaluation of the MicroStent Peripheral Vascular Stent in Subjects With Artery Lesions Below the Knee

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03477604
Recruitment Status : Completed
First Posted : March 26, 2018
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Micro Medical Solution, Inc.

Brief Summary:
This prospective feasibility study is a single arm, non-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 15 subjects will be enrolled at 3 centers and followed for up to 3 years, with the primary safety and efficacy endpoints evaluated 30 days post-implant.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Feasibility Evaluation of the MicroStent Peripheral Vascular Stent in Subjects With Artery Lesions Below the Knee
Actual Study Start Date : April 25, 2018
Actual Primary Completion Date : December 12, 2018
Actual Study Completion Date : December 12, 2018

Arm Intervention/treatment
Experimental: MicroStent
Implant of the MicroStent peripheral vascular stent system for treatment of arterial lesions below the knee.
Device: MicroStent
Self-expanding stent




Primary Outcome Measures :
  1. Patency of the target lesion(s) [ Time Frame: 30 days ]
    Patency is defined as freedom from target lesion occlusion (absence of blood flow via duplex ultrasound) with no clinically driven target lesion revascularization. A clinically driven revascularization is defined as reintervention due to complaints of leg pain/worsening pain, a progressing non-healing ulcer, or new ulcer formation with or without the presence of an abnormal noninvasive test.

  2. Freedom from Major Adverse Limb Events (MALE) and Peri-operative Death (POD) [ Time Frame: 30 days ]
    Freedom from major adverse limb events and perioperative death


Secondary Outcome Measures :
  1. Freedom from amputation [ Time Frame: 30 days ]
    Freedom from major (above ankle) amputation

  2. Reduction in size of leg/foot ulcers [ Time Frame: 30 days ]
    Mean reduction in area (mm^2) of leg/foot ulcers measured via wound camera system



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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:

  • Subject is male or non-pregnant female adult over the age of 21
  • Subject has documented clinical evidence of critical limb ischemia (CLI) in the target limb prior to the study procedure, with a Rutherford classification score of 4-5
  • Subject, or subject's designated legal representative, has been informed of the nature of the study and is willing to provide written informed consent
  • Subject is geographically stable and is able and willing to comply with all study required follow up visits.
  • Subject has a life expectancy > 1 year

Angiographic Inclusion Criteria

  • Target limb has at least a single vessel with runoff to the foot
  • Subject has up to 3 non-contiguous lesions, each with >=70% stenosis and <=5.0cm in length located at or distal to the tibial-peroneal trunk and above the ankle; including the anterior tibial, posterior tibial, or peroneal arteries
  • Target lesion(s) has a reference vessel diameter of 2.5 - 4.5mm to accommodate the test article.
  • Target lesion(s) is able to be crossed with a guidewire to facilitate treatment with the study device.

General Exclusion Criteria:

  • Subject has a prior or planned index limb amputation above the ankle.
  • Subject has a wound/ulcer located on the target limb with a Wound, Ischemia, and foot Infection (WIfI) infection grade >1
  • Subject is pregnant, plans to become pregnant, or is nursing.
  • Subject is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization
  • Subject has a history of coagulation/clotting disorders, acute thrombosis, or is hypercoagulable
  • Subject has allergy to iodinated contrast media
  • Subject is in acute renal failure
  • Subject has active systemic infection
  • 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 enrollment
  • 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.
  • Subject has had any non-diagnostic endovascular or surgical procedure in the lower extremities less than 14 days prior or planned less than 30 days after the index procedure
  • Subject presents with acute limb ischemia or acute thrombosis of the target limb.
  • Subject has experienced myocardial infarction, thrombolysis, or angina less than 30 days prior to the index procedure.
  • Subject has a history of stroke within 3 months of the index procedure.

Angiographic exclusion criteria

  • Presence of hemodynamically significant inflow lesions >15cm in length
  • Failure to obtain <= 30% residual stenosis in hemodynamically significant inflow lesions <=15cm in length
  • Failure to obtain <=30% residual stenosis in hemodynamically significant non-target infrapopliteal lesions
  • In the opinion of the investigator, subject may require use of alternative therapy (e.g. atherectomy, etc.)

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


Locations
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United States, Florida
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Louisiana
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
United States, Michigan
Eastlake Cardiovascular
Roseville, Michigan, United States, 48066
Sponsors and Collaborators
Micro Medical Solution, Inc.

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Responsible Party: Micro Medical Solution, Inc.
ClinicalTrials.gov Identifier: NCT03477604     History of Changes
Other Study ID Numbers: MMS-001
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
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