Clinical Study to Evaluate the Safety and Effectiveness of MER® Stents in Carotid Revascularisation.

Study Overview
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Brief Summary
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The aim of the study is to confirm, whether the MER® stent can be used, without limitations, for the endovascular carotid stenosis treatment in daily clinical practice. Eligible patients will undergo the procedure of the common or internal carotid artery stenting using MER® with proximal or distal neuroprotection.

Detailed Description
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MER® stent will be implanted in eligible patients with common and internal carotid stenosis after an informed consent. Potential benefit of the MER® stent implantation will be evaluated based on angiography and duplex Doppler ultrasound examination. Follow ups are scheduled at 30 days, 6 and 12 months after index procedure. Except for clinical follow up patients will undergo carotid vessels ultrasound examination after 6 and 12 months. In case of an emergency visit, caused by the Serious Adverse Event, Patient will undergo: neurological and cardiac evaluation as well as carotid vessels USG examination and extended CT or MRI scans. In general, all procedures in the study will follow the local standard of care. The type of devices used during the angioplasty (including the MER® stents) will not differ from the devices used in the usual clinical practice in the hospital. DAPT and other medical therapy will be consistent with the rules of the Polish and European Society of Cardiology.

Official Title
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Badanie Kliniczne oceniające bezpieczeństwo i skuteczność Stosowania stentów Szyjnych MER® w Rewaskularyzacji tętnic Szyjnych.

Conditions
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Carotid Artery Stenosis

Intervention / Treatment
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* Device: MER


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: De novo lesion located in the internal carotid artery or common carotid artery DS ≥50% (nonsymptomatic patients) and ≤99% based on QCA DS ≥75% (symptomatic patients) and ≤99% based on QCA Target lesion available for 20-60mm lenght and 4-10mm diameter scaffold Patient eligible for CAS Age ≥ 18 Life expentancy ≥ 12 months The patient's written informed consent has been obtained prior to the procedure. Exclusion Criteria: Lack of neurological CAS qualification The patient has experienced an acute myocardial infarction within 72 hours of the procedure The patient has known paroxysmal, persistent or permanent atrial fibrillation or flutter The patient has known gastrointestinal bleeding Pregnancy DAPT contraindications Surgery planned within 1 month after the procedure A platelet count <100,000/mm³ or >600,000/mm³ The patient has known nickel, titanium or contrast allergy The target vessel is totally occluded The patient has stent(s) in the target lesion Statin therapy contraindications The target lesion has massive calcifications Hyperthyroidism Post-radiotherapy side effects No pulse in femoral artery Chronic kidney disease (creatinine level >2,0 mg/dl or eGFR<30 mL/min/1.73 m2 or dialysotherapy)

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with MER stent<br>Patients eligible for Carotid Artery Stenting | Device: MER<br>* carotid artery stenting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke within 30 days after the procedure | Stroke within 30 days after the procedure | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MAE | compound Major Adverse Events (death, stroke, heart attack) within 30 days after the procedure | 30 days | 
| MAE | compound Major Adverse Events (death, stroke, heart attack) within 365 days after the procedure. Restenosis (%DS ≥50%) within 365 days. | 365 days | 
| Target vessel revascularization within 365 days | Target vessel revascularization within 365 days | 365 days | 
| Procedure success | Procedure success (with residual stenosis ≤30%) | 365 days | 
| SADE | Serious Adverse Device Effect | 365 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carotid artery, stroke, stent