Boston Scientific Embolic Protection, Inc. (EPI): A Carotid Stenting Trial for High-Risk Surgical Patients (BEACH)
NCT ID: NCT00316108
Last Updated: 2014-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
747 participants
INTERVENTIONAL
2002-02-28
2007-11-30
Brief Summary
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Detailed Description
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Although CEA is an effective treatment for the majority of patients with carotid occlusive disease, there remains a need for a treatment option for those patients with significant surgical risk factors. These patients have been shown to have much higher rates of morbidity and mortality. There are approximately 50,000-70,000 patients each year who are considered poor surgical candidates. These patients present with either one or more anatomical or co-morbid conditions and have a one-year stroke and death rate of up to 15% with traditional surgical treatment.
Carotid artery stenting (CAS) has been reported by numerous single-center trials to be feasible in the treatment of carotid artery stenosis. Moreover, the risk benefit ratio has been suggested to be the largest in those patients with a higher risk profile for the CEA treatment option.
This trial will study the effects of percutaneous intervention using the Monorail™ Carotid Wallstent® Endoprosthesis (Carotid Wallstent) in conjunction with the FilterWire System distal protection device (FilterWire EX and EZ) on rates of common peri-procedural complications as well as on long-term outcomes as compared to historical outcomes of patients undergoing CEA.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
WALLSTENT® Endoprosthesis™
Carotid Artery Stent
Interventions
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WALLSTENT® Endoprosthesis™
Carotid Artery Stent
Eligibility Criteria
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Inclusion Criteria
A. Symptomatic: Carotid stenosis of greater than or equal to 50% via angiography with associated cerebral or retinal TIA or ischemic stroke symptoms within 180 days of the procedure, which are determined to have occurred in the cerebral hemisphere or eye ipsilateral to the target carotid artery lesion and to be reasonably attributable to that lesion; or
B. Asymptomatic: Carotid stenosis greater than or equal to 80% via angiography without associated cerebral or retinal TIA or ischemic stroke symptoms within 180 days of the procedure.
* Target lesion is in the native common carotid artery (CCA), internal carotid artery (ICA), or carotid bifurcation.
* Target arterial segment to be stented has a diameter of greater than or equal to 4.0 mm to less than or equal to 9.0 mm.
* Vessel diameter distal to the target lesion is greater than or equal to 3.5 mm and less than or equal to 5.5 mm as an optimal "landing zone" for placement of the FilterWire EZ System with visual angiographic recommendations as described in the instructions for use (IFU).
* Patients must qualify in at least one high-risk category. The high-risk categories are defined as:
* Anatomical conditions \[one (1) criterion qualifies\]
* Co-morbid conditions Class I \[one (1) criterion qualifies\]
* Co-morbid conditions Class II \[two (2) criteria qualify\]
Exclusion Criteria
* 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.
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher White, MD
Role: PRINCIPAL_INVESTIGATOR
Ochsner Health System
Sriram Iyer, MD
Role: PRINCIPAL_INVESTIGATOR
Lenox Hill Heart and Vascular Institute
Pamela G Grady, Ph.D
Role: STUDY_DIRECTOR
Boston Scientific Corporation
Locations
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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
Kaleida Health/Millard Fillmore Hospital
Buffalo, New York, United States
Lenox Hill Heart and Vascular Institute
New York, New York, United States
New York Presbyterian Hospital/Columbia Vascular Interventional Radiology
New York, New York, United States
Strong Memorial Hospital
Rochester, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic & Foundation
Cleveland, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Medical College of Ohio
Toledo, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
Hahnemann University/ Tenet Healthcare Corporation
Philadelphia, Pennsylvania, United States
UPMC-Shadyside Hospital Pittsburgh Vascular Institute
Pittsburgh, Pennsylvania, United States
Pinnacle Health at Harrisburg Hospital
Wormleysburg, Pennsylvania, United States
Providence Hospital South Carolina Heart Center
Columbia, South Carolina, United States
Baptist Hospital of East Tennessee
Knoxville, Tennessee, United States
Skyline Medical Center/ Howell Allen Clinic
Nashville, Tennessee, United States
St. Luke's Episcopal Hospital Texas Heart Institute
Houston, Texas, United States
University of Texas-Houston Medical School
Houston, Texas, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, United States
Baptist Hospital
San Antonio, Texas, United States
LDS Hospital
Salt Lake City, Utah, United States
St. Mary's Hospital
Richmond, Virginia, United States
Deaconess Medical Center
Spokane, Washington, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Countries
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References
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Iyer SS, White CJ, Hopkins LN, Katzen BT, Safian R, Wholey MH, Gray WA, Ciocca R, Bachinsky WB, Ansel G, Joye JD, Russell ME; BEACH Investigators. Carotid artery revascularization in high-surgical-risk patients using the Carotid WALLSTENT and FilterWire EX/EZ: 1-year outcomes in the BEACH Pivotal Group. J Am Coll Cardiol. 2008 Jan 29;51(4):427-34. doi: 10.1016/j.jacc.2007.09.045.
Other Identifiers
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COR2000001U
Identifier Type: -
Identifier Source: secondary_id
S5385
Identifier Type: -
Identifier Source: org_study_id
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