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

Boston Scientific

Status

Completed

Conditions

Carotid Artery Disease

Stroke

Carotid Stenosis

Treatments

Device: Carotid Artery Stenting

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01133327

ASTI

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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