Micronet Covered Stent in in Arterial Locations Beyond the Carotid Bifurcation - FLOW-Guard Study

Study Overview
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Brief Summary
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Prospective observational study of MicroNet covered stent implantation in the elevated risk peripheral lesions (high lesion load, thrombus containing, highly calcified). Open-label, non randomized, single arm observational study. Jagiellonian University Medical College research project.

Detailed Description
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Peripheral artery stents in routine use (both balloon expandable and self-expendable) do not sufficiently prevent distal embolization. They might induce a cheese-grater effect - a consequence of their single layer design with uncovered space between stent struts. Aim of the study is to evaluate short and long term safety and efficacy of MicroNet covered stent implantation in the high risk lesions beyond the carotid bifurcation. Treatment eligibility will be evaluated by a Vascular Team process (angiologist, vascular surgeon, cardiologist). Optimal pharmacotherapy will be administered according to the current guidelines. Symptomatic and asymptomatic patients with peripheral artery disease requiring endovascular treatment for high risk stenosis (soft plaque, highly calcific plaque) per Vascular Team assessment. A group of 30-50 consecutive patients meeting inclusion and exclusion criteria will be enrolled.

Official Title
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Prospective Observational Study of Procedures With MicroNet Covered Stent Use to Treat Increased Risk Lesions in Arterial Locations Beyond the Carotid Bifurcation - FLOW-Guard Study

Conditions
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Peripheral Vascular Diseases

Intervention / Treatment
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* Device: MicroNet covered stent implantation in the increased risk arterial lesions beyond the carotid bifurcation


Participation Criteria
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Eligibility Criteria
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General Inclusion Criteria: Patients older than 18 years, eligible for peripheral artery stenting after Vascular Team evaluation, according to local standards Written, informed consent to participate Agreement to attend protocol required (standard) follow up visits and examinations Exclusion Criteria: Life expectancy <1 year (e.g. active neoplastic disease). Chronic kidney disease with creatinine > 3.0 mg/dL. Myocardial infarction in 72 hours proceeding the stenting procedure (if possible, postponing the procedure) Pregnancy (positive pregnancy test) Coagulopathy. History of uncontrolled contrast media intolerance Angiographic Inclusion Criteria: De novo lesion in major arteries or grafts connecting arteries Stenosis eligible for endovascular treatment per Vascular Team evaluation (according to current standards and guidelines) High risk morphology stenosis (per 2 independent, experienced operators) Exclusion Criteria: Chronic total occlusion not amenable to re-canalization Stent in the target vessel/lesion Anatomic variants precluding stent implantation Mobile (free-floating) plaque elements in aorta or arteries proximal to target lesion

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 |
| --- | --- |
| MicroNet covered stenting (interventional)<br>MicroNet covered stent implantation for increased risk arterial lesions beyond the carotid bifurcation | Device: MicroNet covered stent implantation in the increased risk arterial lesions beyond the carotid bifurcation<br>* Implantation of the MicroNet covered stent in the increased risk arterial lesions beyond the carotid bifurcation as per Vascular Team recommendation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of procedural success | Procedural success, defined as technical success (successful delivery and implantation of the stent) AND residual stenosis ≤ 30% of vessel lumen diameter AND clinical success (no peri-procedural complications) | Up to 48 hours after procedure or until hospital discharge, whichever came first. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of In-hospital MACNE (Major Adverse Cardiovascular or Neurological Events) | In-hospital MACNE (death, stroke, myocardial infarction, acute limb or target organ ischemia) | Up to 48 hours after procedure or until hospital discharge, whichever came first. | 
| Number of MACNE at 30 days | MACNE at 30 days (death, stroke, myocardial infarction, acute limb or target organ ischemia) | At 30 days after procedure | 
| Number of MACNE at 6 months | MACNE at 6 months (death, stroke, myocardial infarction, acute limb or target organ ischemia) | At 6 months after procedure | 
| Rate of peri-procedural complications | Any peri-procedural complications until 48 hrs | Up to 48 hours after procedure | 
| Duplex Ultrasound Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in the stented segment at discharge | Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) on ultrasound evaluation of the stented segment (if accessible) | 24 hours after procedure | 
| Duplex Ultrasound Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in the stented segment at 6 months | Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) on ultrasound evaluation of the stented segment (if accessible) | At 6 months after procedure | 
| Duplex Ultrasound Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in target vessel at 12 months | Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) on ultrasound evaluation of the stented segment (if accessible) | At 12 months after procedure | 
| Vessel patency in CT angiography at 6 months | Vessel patency in CT angiography (if not contraindicated) at 6 months | At 6 months after procedure |