Carotid Artery Disease, Carotid Stenosis, Stroke
Conditions
Keywords
Carotid Artery Stenting, High Risk patient, Carotid artery stenosis, stroke, Carotid artery disease, ASTI study, Adapt Carotid Stent system, FilterWire EZ Embolic Protection System
Brief summary
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
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.
Interventions
DEVICECarotid Artery Stenting
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.
Sponsors
CRO genae
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Medidata Solutions
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day rate of major adverse events | 30-day postprocedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| System Technical Success | the procedure time | 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. |
| Device Malfunctions | from index procedure to 365 days post procedure | Define as any failure of the device to meet performance specifications or otherwise perform as intended, as defined by the investigator. |
| Serious device-related and procedure-device related Events | from index procedure to 365 days post procedure | — |
| Late ipsilateral stroke | 31 through 365 days post procedure | — |
| In-stent Restenosis | from end of index procedure to 365 days post procedure | — |
| Major Adverse Events Rate by subgroups | from index procedure to 365 days post procedure | Major Adverse Events Rate by subgroups * symptomatic and asymptomatic status * per center |
| Target Lesion Revascularization | from end of index procedure to 365 days postprocedure | 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. |
Countries
Belgium, Germany, Spain
Outcome results
None listed