GORE Embolic Protection With Reverse Flow
Summary
To compare the 30-day safety and efficacy of the GORE Flow Reversal System when used with approved carotid stents to an Objective Performance Criterion derived from distal embolic protection studies.
Description
The GORE Flow Reversal System, manufactured by W. L. Gore & Associates, Inc., was developed as a proximal occlusion device to reverse the flow of blood in the carotid artery. It is designed to achieve embolic protection prior to crossing the lesion in the majority of cases in order to minimize the possibility of an adverse event occurrence.
The objective of this study is to assess the safety and effectiveness of the GORE Flow Reversal System when used to provide embolic protection during CAS procedures. Subjects diagnosed with carotid stenosis requiring revascularization and are at high risk for adverse events from CEA are eligible to participate.
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Carotid Artery Stenosis
Intervention
GORE Flow Reversal System (GFRS)
Location
Millard Fillmore Gates/Univ. of Buffalo
Buffalo
New York
United States
14209
Status
Completed
Source
W.L.Gore & Associates
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00594100
- Information obtained from ClinicalTrials.gov on July 30, 2012
Medical and Biotech [MESH] Definitions
Coronary-subclavian Steal Syndrome
A complication of INTERNAL MAMMARY-CORONARY ARTERY ANASTOMOSIS whereby an occlusion or stenosis of the proximal SUBCLAVIAN ARTERY causes a reversal of the blood flow away from the CORONARY CIRCULATION, through the grafted INTERNAL MAMMARY ARTERY (internal thoracic artery), and back to the distal subclavian distribution.
Carotid Artery Thrombosis
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.
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)
Carotid Artery Injuries
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)
Carotid Artery Diseases
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.
Clinical Trials
ViVEXX Carotid Revascularization Trial (VIVA)
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...
Adapt Monorail Carotid Stent System: A Postmarket Clinical Follow-up Study
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 suf...
Frequency Analysis of Carotid Artery Disease
The purpose of this study is to determine if carotid artery stenosis can be detected using an electronic stethoscope. This study will use a commercially available electronic stethoscope t...
The purpose of this study is to detect new ischemic lesions after carotid artery stenting (with the Cristallo Ideale stent), in patients with high grade carotid artery stenosis, by diffusi...
Patients with a moderate to severe carotid atherosclerotic plaque are at risk for stroke and this risk increases with increasing degree of stenosis. It has been shown that carotid endarter...
PubMed Articles
OBJECTIVE: This study evaluates short and long-term results of CAS with the Gore Flow Reversal System (GFRS). BACKGROUND: Embolic protection devices are of fundamental importance in carotid artery ste...
BACKGROUND:: Each of the embolic protection devices used in carotid artery stenting (CAS) has advantages and disadvantages. The prospective, multicenter, single-arm EMPiRE Clinical Study investigated...
Interrelation between the Degree of Carotid Stenosis, Collateral Circulation and Cerebral Perfusion.
Background: In patients with carotid artery stenosis, ipsilateral hemodynamic compromise is associated with an increased risk of stroke. It is unclear which factors determine cerebral perfusion. We st...
BACKGROUND: -To analyze the in-vivo distribution of absolute wall shear stress (WSS(abs)) and oscillatory shear index (OSI) in the carotid bifurcation and to evaluate its dependence on bifurcation geo...
Objectives- To determine the incidence of antegrade internal carotid artery collateral flow in patients with common carotid artery occlusion, which artery supplies blood to the internal carotid artery...
