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Carotid Revascularization Endarterectomy Versus Stenting Trial

2014-08-27 03:58:13 | BioPortfolio

Summary

The purpose of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is to compare the relatively new procedure of stent-assisted carotid angioplasty (CAS) to the traditional and accepted surgical approach of carotid endarterectomy (CEA) for the treatment of carotid artery stenosis to prevent recurrent strokes in those patients who have had a TIA (transient ischemic attack) or a mild stroke within the past 6 months (symptomatic) and in those patients who have not had any symptoms within the past 6 months (asymptomatic).

Description

The primary aim of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is to contrast the relative effectiveness of carotid artery stenting (CAS) versus carotid endarterectomy (CEA) in preventing stroke, myocardial infarction, and death. Stents are medical devices approved and commonly used for treatment of heart disease. The stent that will be used in this trial is the RX ACCULINK(TM) Carotid Stent System, an elastic-like metal scaffold that is expanded inside a carotid artery to hold the vessel open.

The RX ACCUNET(TM) Embolic Protection System (an umbrella-like device that expands above the narrowed portion of the carotid artery) will be used in conjunction with the RX ACCULINK stent. The RX ACCUNET system is designed to capture embolic material that could break off from the narrowed area in the carotid artery while still allowing blood to flow through the vessel during the procedure. Embolic material could block blood flow to the arteries beyond the narrowing and be harmful to the brain. The RX ACCUNET System is closed and removed after the stent is placed.

CEA involves a neck incision and physical removal of the plaque from the inside of the artery. CAS involves insertion of a catheter or tube into an artery in the groin and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck. The stent is then placed to cover the plaque and hold the artery open. Participants will be randomly assigned to undergo either CAS or CEA, and all patients will receive best medical management, which includes treatment with aspirin, treatment of high blood pressure, and treatment of other stroke risk factors. Participants will be followed for up to ten years.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Atherosclerosis

Intervention

Carotid Endarterectomy (CEA), Carotid Artery Stenting (CAS)

Location

University of Alabama at Birmingham
Birmingham
Alabama
United States
35294

Status

Active, not recruiting

Source

University of Medicine and Dentistry New Jersey

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:58:13-0400

Clinical Trials [1798 Associated Clinical Trials listed on BioPortfolio]

Carotid Stenting vs. Surgery of Severe Carotid Artery Disease and Stroke Prevention in Asymptomatic Patients (ACT I)

The study is being conducted to demonstrate the non-inferiority of carotid artery stenting (CAS) using the Emboshield® Embolic Protection System and Emboshield® Pro Embolic Protection Sy...

Carotid Endarterectomy and Carotid Artery Stenting in Brazil

Cerebrovascular disease is a leading cause of death and the leading cause of serious long-term disability. Carotid artery stenting (CAS) and carotid endarterectomy (CEA) are alternative st...

New Ischemic Cerebral Lesions After Endarterectomy vs. Stenting for the Treatment of Symptomatic Carotid Stenosis

Background and purpose. Even if periprocedural cerebral microembolism associated with carotid endarterectomy or stenting usually does not manifest as clinically overt stroke, neuropsycholo...

Endarterectomy vs Stenting in Chinese Asymptomatic Carotid Stenosis Patients

Endarterectomy vs Stenting Asymptomatic Carotid stenosis patients to verify the efficacy and safety.

Autoarterial Remodeling of Bifurcation of the Common Carotid Artery

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PubMed Articles [3207 Associated PubMed Articles listed on BioPortfolio]

The impact of age on in-hospital outcomes after transcarotid artery revascularization, transfemoral carotid artery stenting, and carotid endarterectomy.

Previous data showed superior outcomes of carotid endarterectomy (CEA) compared with transfemoral carotid artery stenting (TFCAS) in elderly patients because of an increased stroke risk in TFCAS-treat...

Synchronous Carotid Endarterectomy and Coronary Artery Bypass Graft (CABG) versus staged Carotid Artery Stenting and CABG for Patients with Concomitant Severe Coronary and Carotid Stenosis: a Systematic Review and Meta-analysis.

Due to the systemic nature of atherosclerosis, medium and large arteries at different sites are commonly simultaneously affected. As a result, severe coronary artery disease (CAD) requiring coronary a...

Carotid Endarterectomy and Carotid Artery Stenting for Patients With Crescendo Transient Ischemic Attacks: A Systematic Review.

Thromboembolic stroke attributable to an ipsilateral carotid artery plaque is a leading cause of disability in the United States and a major source of morbidity. Randomized clinical trials have demons...

Race and sex-based disparities associated with carotid endarterectomy in the Atherosclerosis Risk in Communities (ARIC) study.

The indications for carotid endarterectomy (CEA) are well established. The aim of the current study was to investigate sex and race-based disparities in the incidence of CEA after adjusting for caroti...

Epidemiological analysis of carotid artery stenosis intervention during 10 years in 
the public health system in the largest city in Brazil: stenting has been more 
common than endarterectomy 
.

Stroke is the second leading cause of death worldwide with approximately 5.7 million cases/year and carotid atherosclerosis accounts for 10 to 20% of cases.

Medical and Biotech [MESH] Definitions

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 excision of the thickened, atheromatous tunica intima of a carotid artery.

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)

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.

The splitting of the vessel wall in one or both (left and right) internal carotid arteries (CAROTID ARTERY, INTERNAL). Interstitial hemorrhage into the media of the vessel wall can lead to occlusion of the internal carotid artery and aneurysm formation.

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