Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00316108
Recruitment Status : Completed
First Posted : April 20, 2006
Last Update Posted : August 28, 2014
Information provided by (Responsible Party):
Boston Scientific Corporation

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).

Condition or disease Intervention/treatment Phase
Carotid Artery Diseases Stroke Cerebral Arteriosclerosis Device: WALLSTENT® Endoprosthesis™ Not Applicable

Detailed Description:

Stroke is the third leading cause of death in this country with approximately 600,000 new stroke cases each year. Mortality rates as high as 40 percent have been reported for stroke as a result of ischemia associated with the carotid distribution. Currently, the primary therapy for carotid artery occlusive disease is carotid endarterectomy (CEA) or the surgical removal of atheromatous material from inside the artery.

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 747 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Boston Scientific EPI: A Carotid Stenting Trial for High-Risk Surgical Patients
Study Start Date : February 2002
Actual Primary Completion Date : May 2005
Actual Study Completion Date : November 2007

Arm Intervention/treatment
Experimental: Arm 1 Device: WALLSTENT® Endoprosthesis™
Carotid Artery Stent

Primary Outcome Measures :
  1. 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 [ Time Frame: 1 year ]
  2. peri-procedural (within 30 days of procedure) death, stroke, Q-wave myocardial infarction [ Time Frame: Within 30 days of Procedure ]
  3. late ipsilateral stroke or death due to neurologic events from 31 days up to and including twelve-month follow-up. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Peri-procedural morbidity and mortality [ Time Frame: Within 30 Days of procedure ]
  2. FilterWire EX and EZ System technical success [ Time Frame: Post procedure ]
  3. Carotid Wallstent technical success [ Time Frame: Post Procedure ]
  4. system technical success [ Time Frame: Post Procedure ]
  5. angiographic success [ Time Frame: Post Procedure ]
  6. procedural success [ Time Frame: Post Procedure ]
  7. 30-day clinical success [ Time Frame: 30 days post procedure ]
  8. peri-procedural overall morbidity [ Time Frame: 30 days post procedure ]
  9. one-year clinical success [ Time Frame: 1 Year post procedure ]
  10. late stroke, transient ischemic attack (TIA) and death. [ Time Frame: 1 year post procedure ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key General Inclusion Criteria:

  • 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).

Key High-Risk Eligibility Inclusion Criteria:

  • 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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00316108

Show Show 50 study locations
Sponsors and Collaborators
Boston Scientific Corporation
Layout table for investigator information
Principal Investigator: Christopher White, MD Ochsner Health System
Principal Investigator: Sriram Iyer, MD Lenox Hill Heart and Vascular Institute
Study Director: Pamela G Grady, Ph.D Boston Scientific Corporation
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Boston Scientific Corporation Identifier: NCT00316108    
Other Study ID Numbers: S5385
First Posted: April 20, 2006    Key Record Dates
Last Update Posted: August 28, 2014
Last Verified: August 2014
Keywords provided by Boston Scientific Corporation:
Carotid Artery Stenting
Carotid Endarterectomy
Transient Ischemic Attack
Atherosclerotic Disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Carotid Artery Diseases
Intracranial Arteriosclerosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Intracranial Arterial Diseases