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Multicenter, prospective, study designed to demonstrate the performance and safety of the Lumen Biomedical, Inc. FiberNet Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention. The primary endpoint is the rate of all stoke and death within 30 days of the procedure.
The purpose of this feasibility study is to demonstrate the performance and safety of the Lumen Biomedical, Inc. FiberNet® Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention. The feasibility study will involve a maximum of 50 subjects to be enrolled using the FiberNet® during clinically indicated percutaneous intervention of the carotid artery and followed through 30 days post procedure. Subject will be enrolled in up to 5 European Investigational Sites. The study is a prospective multi-center registry with sequential enrollment of qualified subjects who consent to participate and meet all entrance criteria.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Carotid Artery Stenosis
FiberNet Embolic Protection Device
Published on BioPortfolio: 2010-07-15T17:00:00-0400
Multicenter, prospective, feasibility study designed to demonstrate the performance and safety of the Lumen Biomedical, Inc. FiberNet™ Embolic Protection System as an adjunctive device d...
To evaluate the procedural safety and filter efficiency of the FiberNet® Embolic Protection System when used in conjunction with the Boston Scientific Express SD Stent System for primary ...
The purposes of this study are: 1. To confirm the PROTÉGÉ ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device are safe and effective in t...
To evaluate the safety and efficacy of the Bard ViVEXX Carotid Stent and Emboshield BareWire Rapid Exchange Embolic Protection System in the treatment of extracranial carotid artery stenos...
This is a multicenter, prospective study designed to demonstrate the performance and safety of the FiberNet Embolic Protection System when used as an adjunctive device during saphenous vei...
Significant national variation exists in defining the degree of stenosis that requires intervention in patients with asymptomatic carotid artery stenosis (ACAS). We aimed to evaluate the risk of perio...
Results from studies investigating the effect of contralateral carotid artery occlusion (CCO) in patients with carotid artery stenosis undergoing carotid artery endarterectomy (CEA) or carotid artery ...
Carotid endarterectomy (CEA) and carotid artery stenting (CAS) are the 2 current standard treatments for carotid artery stenosis. There is still no well-defined consensus with regard to their superior...
Carotid artery stenting (CAS) has been widely accepted as a valuable therapeutic alternative to carotid endarterectomy (CEA) for high-grade carotid stenosis. Because carotid revascularization includin...
It is unclear whether incidental carotid artery calcification (CAC) on radiographs has a defined relationship to clinically significant carotid artery stenosis, and therefore risk of stroke. The prima...
Blood clot formation in any part of the CAROTID ARTERIES. This may produce CAROTID STENOSIS or occlusion of the vessel, leading to TRANSIENT ISCHEMIC ATTACK; CEREBRAL INFARCTION; or AMAUROSIS FUGAX.
Transient complete or partial monocular blindness due to retinal ischemia. This may be caused by emboli from the CAROTID ARTERY (usually in association with CAROTID STENOSIS) and other locations that enter the central RETINAL ARTERY. (From Adams et al., Principles of Neurology, 6th ed, p245)
Damages to the CAROTID ARTERIES caused either by blunt force or penetrating trauma, such as CRANIOCEREBRAL TRAUMA; THORACIC INJURIES; and NECK INJURIES. Damaged carotid arteries can lead to CAROTID ARTERY THROMBOSIS; CAROTID-CAVERNOUS SINUS FISTULA; pseudoaneurysm formation; and INTERNAL CAROTID ARTERY DISSECTION. (From Am J Forensic Med Pathol 1997, 18:251; J Trauma 1994, 37:473)
Pathological conditions involving the CAROTID ARTERIES, including the common, internal, and external carotid arteries. ATHEROSCLEROSIS and TRAUMA are relatively frequent causes of carotid artery pathology.
The two principal arteries supplying the structures of the head and neck. They ascend in the neck, one on each side, and at the level of the upper border of the thyroid cartilage, each divides into two branches, the external (CAROTID ARTERY, EXTERNAL) and internal (CAROTID ARTERY, INTERNAL) carotid arteries.