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An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease (HEAL)

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: NCT04110327
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Micro Medical Solution, Inc.

Brief Summary:
Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStent™ System.

Condition or disease Intervention/treatment
Peripheral Arterial Disease Peripheral Artery Disease Critical Limb Ischemia Critical Lower Limb Ischemia Device: MicroStent

Detailed Description:

Subjects with peripheral arterial disease (PAD) whom the investigator has treated or intends to treat with the MicroStent™ System per the current instructions for use (IFU), and who have given written informed consent, will be enrolled in this study. Up to 250 subjects in three cohorts will be enrolled:

Up to 100 subjects or 1-year recruitment, whichever comes first in Cohort #1: Claudication; Rutherford ≤3 Up to 100 subjects or 1-year recruitment, whichever comes first in Cohort #2: Critical Limb Ischemia; Rutherford 4-5 Up to 50 subjects or 1-year recruitment, whichever comes first in Cohort #3: Critical Limb Ischemia w/major tissue loss; Rutherford 6

Sites may follow routine follow up intervals per their standard of care, with data regarding clinical assessments regarding limb status being collected. Data from these visits that do not fall in the expected visit windows will be captured in the study database as unscheduled visits.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 2 Years
Official Title: An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
Actual Study Start Date : October 31, 2019
Estimated Primary Completion Date : April 5, 2021
Estimated Study Completion Date : October 5, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Claudication
Subjects presenting with claudication, identified as Rutherford category 1, 2, or 3
Device: MicroStent
Treatment of arterial stenosis or occlusion with the MicroStent Perihperal Vascular Stent System

Critical Limb Ischemia
Subjects presenting with rest pain (Rutherford category 4) or minor tissue loss (Rutherford category 5)
Device: MicroStent
Treatment of arterial stenosis or occlusion with the MicroStent Perihperal Vascular Stent System

Critical Limb Ischemia with major tissue loss
Subjects presenting with major tissue loss (Rutherford 6)
Device: MicroStent
Treatment of arterial stenosis or occlusion with the MicroStent Perihperal Vascular Stent System




Primary Outcome Measures :
  1. Primary Patency [ Time Frame: 6 months post-procedure ]
    Freedom from target lesion occlusion with no clinically driven target lesion revascularization (TLR)

  2. Freedom from Perioperative Death and Major Adverse Limb Events (MALE) [ Time Frame: 30 days post-procedure ]
    Freedom from all-cause death or major adverse limb events. Major adverse limb events include above-ankle amputation, new bypass graft or graft revision, and thrombectomy or thrombolysis involving the target lesion.


Secondary Outcome Measures :
  1. Freedom from Major Adverse Limb Events [ Time Frame: 6, 12, 24 Months ]
    Major adverse limb events include above-ankle amputation, new bypass graft or graft revision, and thrombectomy or thrombolysis involving the target lesion.

  2. Freedom from Major Amputation [ Time Frame: 6, 12, 24 Months ]
    Freedom from above-ankle amputation in the target limb

  3. Freedom from Clinically Driven Target Lesion Revascularization (TLR) [ Time Frame: 6, 12, 24 Months ]
    Freedom from any revascularization procedure with involvement of the target lesion that is due to complaints of leg pain or worsening leg pain, a progressing, non-healing ulcer, or new ulcer formation with or without the presence of an abnormal non-invasive test.

  4. Wound Healing [ Time Frame: 30 days, 6, 12, 24 Months ]
    Wounds will be identified at the baseline visit and classified as fully healed or not healed at each follow up visit.

  5. Device Success [ Time Frame: Procedure ]
    Operator assessment of successful device deployment and full coverage of the lesion as intended

  6. Technical Success [ Time Frame: Procedure ]
    Attainment of less than or equal to 30% residual stenosis by visual estimate in the treated lesion using only the study device according to the IFU (i.e. including post dilation at the discretion of the investigator)



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will include any subjects with symptomatic peripheral arterial disease (PAD) that require intervention with the MicroStent™ System.
Criteria

Inclusion Criteria:

  1. Any subject with peripheral arterial lesions previously treated or intended to be treated with the MicroStent™ System per the current indications for use.
  2. Age ≥18 years old
  3. Patient must be willing to sign a patient informed consent form

Exclusion Criteria:

  1. Subject is pregnant or is planning to become pregnant during the course of the study.
  2. Life expectancy of less than 1 year.
  3. Known allergy to concomitant medications, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant, or thrombolytic medications.
  4. Subject is enrolled in another study that has not reached its primary endpoint at the time of enrollment.

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): NCT04110327


Contacts
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Contact: Ian Schorn (320) 282-6312 ischorn@micromedicalsolutions.net

Locations
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Belgium
OLV Hospital Recruiting
Aalst, Belgium
Contact: Lieven Maene, MD         
A.Z. Sint-Blasius Recruiting
Dendermonde, Belgium
Contact: Koen Deloose, MD         
Italy
Policlinico Abano Terme Recruiting
Abano Terme, Italy
Contact: Marco Manzi, MD         
Sponsors and Collaborators
Micro Medical Solution, Inc.
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Responsible Party: Micro Medical Solution, Inc.
ClinicalTrials.gov Identifier: NCT04110327    
Other Study ID Numbers: MMS-201
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: December 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: No
Keywords provided by Micro Medical Solution, Inc.:
MicroStent
Below the Knee
CLI
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Ischemia
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases