Boston Scientific Embolic Protection, Inc. (EPI): A Carotid Stenting Trial for High-Risk Surgical Patients (BEACH)

Completed · Not applicable

Conditions studied: Carotid Artery Diseases, Stroke, Cerebral Arteriosclerosis

In brief

The purpose of this study is to determine whether morbidity and mortality for high-risk surgical patients treated with the Carotid Wallstent in conjunction with the FilterWire EX and EZ System distal protection device will be less than or equal to that of objective performance criteria (OPC) derived from historic controls undergoing surgical intervention with a carotid endarterectomy (CEA).

Key facts

Study ID

NCT00316108

Run by

Boston Scientific Corporation

People needed

747

Starts

2002-02-01

Expected to finish

2007-11-01

Last updated by the study team

2014-08-28

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patient has experienced an evolving, acute, or recent stroke within 21 days of study evaluation.
• A total occlusion of the ipsilateral carotid artery. (Only for Roll-In and Pivotal patients.)
• A total occlusion of the contralateral carotid artery. (Only for Bilateral Registry patients.)
• Pre-existing stent(s):
• Roll-In and Pivotal Patients: located within the ipsilateral carotid distribution; a stent was placed in a contralateral vessel within the previous 30 days of the study enrollment.
• Bilateral Registry Patients: located within the carotid distribution.
• A target lesion which is expected to require more than one stent.
• Known cardiac sources of emboli of a type likely to be associated with cerebral ischemic events [e.g. endocarditis, intracardiac thrombus, embolic-associated cardiovascular lesions, or any current arrhythmia (e.g. atrial fibrillation, atrial flutter, etc.)].
• Myocardial infarction (MI) within 72 hours prior to the index procedure, defined as creatine kinase (CK)-MB > 2 X the local laboratory's upper limit of normal (ULN).
• Any surgery requiring general anesthesia (e.g. coronary artery bypass graft [CABG], valve replacement, or abdominal aortic aneurysm) less than or equal to 30 days preceding the stent procedure.
• The patient is enrolled in another investigational study protocol and has not completed the required follow-up period of the evaluation. The patient may not participate in another investigational study that may confound the treatment or outcomes of the BEACH protocol.

Where it is running

• Bapatist Medical Center — Birmingham, Alabama, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Arizona Heart Institute — Phoenix, Arizona, United States
• St. Joseph's Hospital & Medical Center — Phoenix, Arizona, United States
• El Camino Hospital — Mountain View, California, United States
• Hoag Memorial Hospital — Newport Beach, California, United States
• St. Joseph's Medical Center — Stockton, California, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Lakeland Regional Medical Center — Lakeland, Florida, United States
• University of Miami School of Medicine - Jackson Memorial Hospital — Miami, Florida, United States
• Miami Cardiac and Vascular Institute — Miami, Florida, United States
• Northwest Medical Center — Plantation, Florida, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• St. Joseph's Hospital of Atlanta/American Cardiovascular Research Institute — Atlanta, Georgia, United States
• Rush Presbyterian-St. Luke's Medical Center — Chicago, Illinois, United States
• St. Francis Medical Center — Peoria, Illinois, United States
• St. John's Hospital - Prairie Heart Institute — Springfield, Illinois, United States
• Central Baptist Hospital — Lexington, Kentucky, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Cape Cod Hospital — Hyannis, Massachusetts, United States
• Wayne State University- Detroit Medical Center — Detroit, Michigan, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• St. Luke's Hospital of Kansas City — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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