MedTrace Logo

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

NCT00316108 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 747

Last updated 2014-08-28

No results posted yet for this study

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

Interventions

DEVICE

WALLSTENT® Endoprosthesis™

Carotid Artery Stent

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Christopher White, MD · Ochsner Health System

  • Sriram Iyer, MD · Lenox Hill Heart and Vascular Institute

  • Pamela G Grady, Ph.D · Boston Scientific Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2005-05-31
Completion
2007-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00316108 on ClinicalTrials.gov