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

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

Detailed Description
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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.

Official Title
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An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease

Conditions
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Peripheral Arterial Disease, Peripheral Artery Disease, Critical Limb Ischemia, Critical Lower Limb Ischemia

Intervention / Treatment
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* Device: MicroStent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any subject with peripheral arterial lesions previously treated or intended to be treated with the MicroStent™ System per the current indications for use. Age ≥18 years old Patient must be willing to sign a patient informed consent form Exclusion Criteria: Subject is pregnant or is planning to become pregnant during the course of the study. Life expectancy of less than 1 year. Known allergy to concomitant medications, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant, or thrombolytic medications. Subject is enrolled in another study that has not reached its primary endpoint at the time of enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Claudication<br>Subjects presenting with claudication, identified as Rutherford category 1, 2, or 3 | Device: MicroStent<br>* Treatment of arterial stenosis or occlusion with the MicroStent Perihperal Vascular Stent System<br>|
| Critical Limb Ischemia<br>Subjects presenting with rest pain (Rutherford category 4) or minor tissue loss (Rutherford category 5) | Device: MicroStent<br>* Treatment of arterial stenosis or occlusion with the MicroStent Perihperal Vascular Stent System<br>|
| Critical Limb Ischemia with major tissue loss<br>Subjects presenting with major tissue loss (Rutherford 6) | Device: MicroStent<br>* Treatment of arterial stenosis or occlusion with the MicroStent Perihperal Vascular Stent System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Patency | Freedom from target lesion occlusion with no clinically driven target lesion revascularization (TLR) | 6 months post-procedure | 
| Freedom from Perioperative Death and Major Adverse Limb Events (MALE) | 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. | 30 days post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from 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. | 6, 12, 24 Months | 
| Freedom from Major Amputation | Freedom from above-ankle amputation in the target limb | 6, 12, 24 Months | 
| Freedom from Clinically Driven Target Lesion Revascularization (TLR) | 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. | 6, 12, 24 Months | 
| Wound Healing | Wounds will be identified at the baseline visit and classified as fully healed or not healed at each follow up visit. | 30 days, 6, 12, 24 Months | 
| Device Success | Operator assessment of successful device deployment and full coverage of the lesion as intended | Procedure | 
| Technical Success | 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) | Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MicroStent, Below the Knee, CLI