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Carotid Artery DiseasesBEACHNCT00316108

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

A study testing WALLSTENT® Endoprosthesis™ in people with Carotid Artery Diseases and Stroke, run by Boston Scientific Corporation at 50 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
What is being tested?
WALLSTENT® Endoprosthesis™
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
747 participants
Where
50 sitesUnited States
Study dates
Feb 2002to Nov 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

United States50 sites

  • Piedmont Hospital

    Atlanta, Georgia, 30309

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

    Atlanta, Georgia, 30342

  • Bapatist Medical Center

    Birmingham, Alabama, 35211

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Kaleida Health/Millard Fillmore Hospital

    Buffalo, New York, 14209

  • Rush Presbyterian-St. Luke's Medical Center

    Chicago, Illinois, 60612

  • Cleveland Clinic & Foundation

    Cleveland, Ohio, 44195

  • Providence Hospital South Carolina Heart Center

    Columbia, South Carolina, 29204

  • Riverside Methodist Hospital

    Columbus, Ohio, 43202

  • Wayne State University- Detroit Medical Center

    Detroit, Michigan, 48034

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • St. Luke's Episcopal Hospital Texas Heart Institute

    Houston, Texas, 77030

  • University of Texas-Houston Medical School

    Houston, Texas, 77030

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • St. Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Baptist Hospital of East Tennessee

    Knoxville, Tennessee, 37920

  • Lakeland Regional Medical Center

    Lakeland, Florida, 33805

  • Central Baptist Hospital

    Lexington, Kentucky, 40504

  • Texas Tech University Health Sciences Center

    Lubbock, Texas, 79430

  • University of Miami School of Medicine - Jackson Memorial Hospital

    Miami, Florida, 33101

  • Miami Cardiac and Vascular Institute

    Miami, Florida, 33176

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • El Camino Hospital

    Mountain View, California, 94040

  • Skyline Medical Center/ Howell Allen Clinic

    Nashville, Tennessee, 37207

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Lenox Hill Heart and Vascular Institute

    New York, New York, 10021

  • New York Presbyterian Hospital/Columbia Vascular Interventional Radiology

    New York, New York, 10032

  • Hoag Memorial Hospital

    Newport Beach, California, 92658

  • St. Francis Medical Center

    Peoria, Illinois, 61637

  • Hahnemann University/ Tenet Healthcare Corporation

    Philadelphia, Pennsylvania, 19102

  • Arizona Heart Institute

    Phoenix, Arizona, 85006

  • St. Joseph's Hospital & Medical Center

    Phoenix, Arizona, 85013

  • UPMC-Shadyside Hospital Pittsburgh Vascular Institute

    Pittsburgh, Pennsylvania, 15232

  • Northwest Medical Center

    Plantation, Florida, 33324

  • Oregon Health Sciences University

    Portland, Oregon, 97201

  • St. Mary's Hospital

    Richmond, Virginia, 23226

  • Strong Memorial Hospital

    Rochester, New York, 14603

  • St. Francis Hospital

    Roslyn, New York, 11576

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Baptist Hospital

    San Antonio, Texas, 78201

  • Deaconess Medical Center

    Spokane, Washington, 99204

  • St. John's Hospital - Prairie Heart Institute

    Springfield, Illinois, 62701

  • St. Joseph's Medical Center

    Stockton, California, 95204

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Medical College of Ohio

    Toledo, Ohio, 43614

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Pinnacle Health at Harrisburg Hospital

    Wormleysburg, Pennsylvania, 17101

Other trials in United States

About this study

Official title: Boston Scientific EPI: A Carotid Stenting Trial for High-Risk Surgical Patients

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).

Read the 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.

Being tested
WALLSTENT® Endoprosthesis™
Keywords
Carotid, Carotid Artery Stenting, Stent, Carotid Endarterectomy, Stroke, Transient Ischemic Attack, Stenosis, Atherosclerotic Disease
Medical subject headings
Carotid Artery Diseases, Stroke, Intracranial Arteriosclerosis, Ischemic Attack, Transient, Constriction, Pathologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WALLSTENT® Endoprosthesis™Device

    Carotid Artery Stent

Study groups in NCT00316108
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Device: WALLSTENT® Endoprosthesis™

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 year

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

    Measured: 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.

    Measured: 1 year

Secondary outcomes (10)

  1. Peri-procedural morbidity and mortality

    Measured: Within 30 Days of procedure

  2. FilterWire EX and EZ System technical success

    Measured: Post procedure

  3. Carotid Wallstent technical success

    Measured: Post Procedure

  4. system technical success

    Measured: Post Procedure

  5. angiographic success

    Measured: Post Procedure

  6. procedural success

    Measured: Post Procedure

  7. 30-day clinical success

    Measured: 30 days post procedure

  8. peri-procedural overall morbidity

    Measured: 30 days post procedure

  9. one-year clinical success

    Measured: 1 Year post procedure

  10. late stroke, transient ischemic attack (TIA) and death.

    Measured: 1 year post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2006 (estimated)
  2. Study startFeb 2002
  3. Primary completionMay 2005
  4. Study completionNov 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
747 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00316108
Sponsor's protocol ID
S5385
Other IDs
COR2000001U
Acronym
BEACH
Status last verified
Aug 2014
First submitted
18 Apr 2006
Last updated
28 Aug 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18222352

Questions about this trial

What is this clinical trial studying?

A study testing WALLSTENT® Endoprosthesis™ in people with Carotid Artery Diseases and Stroke, run by Boston Scientific Corporation at 50 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00316108, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2014.

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