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

NCT00316108 | Completed DMC

• 2 other identifiers: S5385COR2000001U
• Study Type: interventional
• Target: 747
• Locations: 1 country
• Sites: 50

Brief Summary

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).

Conditions

Carotid Artery Diseases; Stroke; Cerebral Arteriosclerosis

Keywords

Carotid; Carotid Artery Stenting; Stent; Carotid Endarterectomy; Stroke; Transient Ischemic Attack; Stenosis; Atherosclerotic Disease

Outcome Measures

Primary Outcomes (3)

• The primary endpoint is one-year morbidity and mortality, defined as the cumulative incidence of any non Q-wave myocardial infarction within the 24 hours following carotid stenting

  1 year

• peri-procedural (within 30 days of procedure) death, stroke, Q-wave myocardial infarction

  Within 30 days of Procedure

• late ipsilateral stroke or death due to neurologic events from 31 days up to and including twelve-month follow-up.

  1 year

Secondary Outcomes (10)

• Peri-procedural morbidity and mortality

  Within 30 Days of procedure

• FilterWire EX and EZ System technical success

  Post procedure

• Carotid Wallstent technical success

  Post Procedure

• system technical success

  Post Procedure

• angiographic success

  Post Procedure

Study Arms (1)

Arm 1

EXPERIMENTAL

Device: WALLSTENT® Endoprosthesis™

Interventions

WALLSTENT® Endoprosthesis™ DEVICE

Carotid Artery Stent

Arm 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must meet criteria for either A or B:
• 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 \[two (2) criteria qualify\]

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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (50)

Bapatist Medical Center

Birmingham, Alabama, 35211, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Arizona Heart Institute

Phoenix, Arizona, 85006, United States

Location

St. Joseph's Hospital & Medical Center

Phoenix, Arizona, 85013, United States

Location

El Camino Hospital

Mountain View, California, 94040, United States

Location

Hoag Memorial Hospital

Newport Beach, California, 92658, United States

Location

St. Joseph's Medical Center

Stockton, California, 95204, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

Lakeland Regional Medical Center

Lakeland, Florida, 33805, United States

Location

University of Miami School of Medicine - Jackson Memorial Hospital

Miami, Florida, 33101, United States

Location

Miami Cardiac and Vascular Institute

Miami, Florida, 33176, United States

Location

Northwest Medical Center

Plantation, Florida, 33324, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

St. Joseph's Hospital of Atlanta/American Cardiovascular Research Institute

Atlanta, Georgia, 30342, United States

Location

Rush Presbyterian-St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

St. Francis Medical Center

Peoria, Illinois, 61637, United States

Location

St. John's Hospital - Prairie Heart Institute

Springfield, Illinois, 62701, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40504, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Cape Cod Hospital

Hyannis, Massachusetts, 02601, United States

Location

Wayne State University- Detroit Medical Center

Detroit, Michigan, 48034, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

St. Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Kaleida Health/Millard Fillmore Hospital

Buffalo, New York, 14209, United States

Location

Lenox Hill Heart and Vascular Institute

New York, New York, 10021, United States

Location

New York Presbyterian Hospital/Columbia Vascular Interventional Radiology

New York, New York, 10032, United States

Location

Strong Memorial Hospital

Rochester, New York, 14603, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic & Foundation

Cleveland, Ohio, 44195, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43202, United States

Location

Medical College of Ohio

Toledo, Ohio, 43614, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97201, United States

Location

Hahnemann University/ Tenet Healthcare Corporation

Philadelphia, Pennsylvania, 19102, United States

Location

UPMC-Shadyside Hospital Pittsburgh Vascular Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

Pinnacle Health at Harrisburg Hospital

Wormleysburg, Pennsylvania, 17101, United States

Location

Providence Hospital South Carolina Heart Center

Columbia, South Carolina, 29204, United States

Location

Baptist Hospital of East Tennessee

Knoxville, Tennessee, 37920, United States

Location

Skyline Medical Center/ Howell Allen Clinic

Nashville, Tennessee, 37207, United States

Location

St. Luke's Episcopal Hospital Texas Heart Institute

Houston, Texas, 77030, United States

Location

University of Texas-Houston Medical School

Houston, Texas, 77030, United States

Location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

Baptist Hospital

San Antonio, Texas, 78201, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

St. Mary's Hospital

Richmond, Virginia, 23226, United States

Location

Deaconess Medical Center

Spokane, Washington, 99204, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (1)

• 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.

  PMID: 18222352 DERIVED

MeSH Terms

Conditions

Carotid Artery Diseases; Stroke; Intracranial Arteriosclerosis; Ischemic Attack, Transient; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Brain Ischemia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher White, MD

  Ochsner Health System

  PRINCIPAL INVESTIGATOR

• Sriram Iyer, MD

  Lenox Hill Heart and Vascular Institute

  PRINCIPAL INVESTIGATOR

• Pamela G Grady, Ph.D

  Boston Scientific Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2006
• First Posted: April 20, 2006
• Study Start: February 1, 2002
• Primary Completion: May 1, 2005
• Study Completion: November 1, 2007
• Last Updated: August 28, 2014

Record last verified: 2014-08

Locations

US (50)