Adapt Monorail Carotid Stent System: A Postmarket Clinical Follow-up Study

Study Overview
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Brief Summary
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The purpose of this study is to get outcomes data for the Adapt Monorail Carotid System used in conjunction with the FilterWire Embolic protection system for treatment of patients that suffer from carotid artery stenosis and that cannot have surgery due to high risk factors.

Detailed Description
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According to the World Health Organization, 15 million people suffer stroke each year. Of these, 5 million die and another 5 million are permanently disabled. Predominant mechanism responsible for stroke is embolism from proximal rupture of atherosclerotic plaque and thrombus. 25-30% of stroke deaths related to the carotid stenosis. The primary therapy for carotid occlusive disease is the surgical removal of this atherosclerotic plaque from inside the artery. Another treatment option for subjects with significant surgical risk factors has been found: the carotid artery stenting is a non-surgical procedure which unblocks narrowing of the carotid artery lumen by inserting a small metal tube (stent) to keep the plaque against the wall of the artery to improve blood flow.

Official Title
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Adapt™ Monorail™ Carotid Stent System: A Postmarket Clinical Follow-up Study

Conditions
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Carotid Artery Disease, Carotid Stenosis, Stroke

Intervention / Treatment
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* Device: Carotid Artery Stenting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: High-risk for carotid endarterectomy due to anatomical or co-morbid conditions and either has neurological symptoms and ≥ 50% stenosis, via angiography or is asymptomatic and has ≥ 80% stenosis, via angiography Target lesion located in the common carotid artery (CCA), internal carotid artery (ICA), or carotid bifurcation Arterial segment to be stented has a diameter between 4mm and 9mm Age ≥ 18 years Life expectancy > 12 months from the date of the index procedure Exclusion Criteria: Contraindication to percutaneous transluminal angioplasty (PTA) Severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system Lesions in the ostium of the common carotid artery Occlusion of the target vessel Evidence of intraluminal thrombus Known sensitivity to nickel-titanium Known allergy to heparin, aspirin or other anticoagulant/ antiplatelet therapies, or is unable or unwilling to tolerate such therapies Uncorrectable bleeding disorders, or will refuse blood transfusions History of prior life-threatening contrast media reaction Previous stent placement in the target vessel Evolving stroke or intracranial hemorrhage Previous intracranial hemorrhage or brain surgery within the past 12 months Clinical condition that makes endovascular therapy impossible or hazardous

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: Adapt Carotid Stent System<br>Intervention with Adapt Carotid Stent System with the FilterWire EZ System | Device: Carotid Artery Stenting<br>* The Adapt Carotid Stent System is intended to deliver a self-expanding Stent to the extra-cranial carotid arteries via a sheathed percutaneous Monorail delivery system. The Adapt Carotid Stent is a closed cell, self-expanding, rolled nitinol (nickel-titanium alloy) sheet. The stent is thin, flexible and expands to appose the vessel wall. The FilterWire EZ System is a temporary intravascular guide wire filtration system that is placed in the vessel distal to the lesion to be treated. It consists of either a polyurethane filter bag 1.5 cm in length or a Bionate (polycarbonate urethane) filter bag, 1.0 cm in length attached near the distal end of a 0.014 silicone coated stainless steel guide wire by means of a collapsible, self-conforming, Nitinol filter loop wire.<br>* Other names: FilterWire Embolic Protection System 3.5 mm - 5.5 mm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day rate of major adverse events | 30-day rate of major adverse events, defined as the cumulative incidence of any peri-procedural (less or equal to 30 days postprocedure) death, stroke, or Myocardial Infarction | 30-day postprocedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late ipsilateral stroke |  | 31 through 365 days post procedure | 
| System Technical Success | successful placement and retireval of the FilterWire EZ System, and the successful deployment of the Adapt Carotid Stent sytem in the target carotid artery, with a residual stenosis < or equal to 30% as determined by the core lab. | the procedure time | 
| Device Malfunctions | Define as any failure of the device to meet performance specifications or otherwise perform as intended, as defined by the investigator. | from index procedure to 365 days post procedure | 
| Serious device-related and procedure-device related Events |  | from index procedure to 365 days post procedure | 
| Target Lesion Revascularization | any surgical or percutaneous attempt to revascularize the target lesion after the initial or index treatment when the diameter restenosis is either equal to 50% or above with symptoms related to the target lesion or 80% or above without symptoms related to the target lesion. | from end of index procedure to 365 days postprocedure | 
| In-stent Restenosis |  | from end of index procedure to 365 days post procedure | 
| Major Adverse Events Rate by subgroups | Major Adverse Events Rate by subgroups symptomatic and asymptomatic status per center | from index procedure to 365 days post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carotid Artery Stenting, High Risk patient, Carotid artery stenosis, stroke, Carotid artery disease, ASTI study, Adapt Carotid Stent system, FilterWire EZ Embolic Protection System