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

Stroke Clinical Trial

— BEACH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00316108
• Other study ID #: S5385
• Secondary ID: COR2000001U
• Status: Completed
• Phase: N/A
• First received: April 18, 2006
• Last updated: August 26, 2014
• Start date: February 2002
• Est. completion date: November 2007

Study information

• Verified date: August 2014
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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 controls undergoing surgical intervention with a carotid endarterectomy (CEA).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 747
• Est. completion date: November 2007
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriosclerosis
• Carotid Artery Diseases
• Cerebral Arteriosclerosis
• Intracranial Arteriosclerosis
• Stroke

Intervention

Device:
• WALLSTENT® Endoprosthesis™
Carotid Artery Stent

Locations

Country	Name	City	State
United States	Piedmont Hospital	Atlanta	Georgia
United States	St. Joseph's Hospital of Atlanta/American Cardiovascular Research Institute	Atlanta	Georgia
United States	Bapatist Medical Center	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Kaleida Health/Millard Fillmore Hospital	Buffalo	New York
United States	Rush Presbyterian-St. Luke's Medical Center	Chicago	Illinois
United States	Cleveland Clinic & Foundation	Cleveland	Ohio
United States	Providence Hospital South Carolina Heart Center	Columbia	South Carolina
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Wayne State University- Detroit Medical Center	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Holy Cross Hospital	Ft. Lauderdale	Florida
United States	St. Luke's Episcopal Hospital Texas Heart Institute	Houston	Texas
United States	University of Texas-Houston Medical School	Houston	Texas
United States	Cape Cod Hospital	Hyannis	Massachusetts
United States	St. Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Baptist Hospital of East Tennessee	Knoxville	Tennessee
United States	Lakeland Regional Medical Center	Lakeland	Florida
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Texas Tech University Health Sciences Center	Lubbock	Texas
United States	Miami Cardiac and Vascular Institute	Miami	Florida
United States	University of Miami School of Medicine - Jackson Memorial Hospital	Miami	Florida
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	El Camino Hospital	Mountain View	California
United States	Skyline Medical Center/ Howell Allen Clinic	Nashville	Tennessee
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
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	Hoag Memorial Hospital	Newport Beach	California
United States	St. Francis Medical Center	Peoria	Illinois
United States	Hahnemann University/ Tenet Healthcare Corporation	Philadelphia	Pennsylvania
United States	Arizona Heart Institute	Phoenix	Arizona
United States	St. Joseph's Hospital & Medical Center	Phoenix	Arizona
United States	UPMC-Shadyside Hospital Pittsburgh Vascular Institute	Pittsburgh	Pennsylvania
United States	Northwest Medical Center	Plantation	Florida
United States	Oregon Health Sciences University	Portland	Oregon
United States	St. Mary's Hospital	Richmond	Virginia
United States	Strong Memorial Hospital	Rochester	New York
United States	St. Francis Hospital	Roslyn	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	LDS Hospital	Salt Lake City	Utah
United States	Baptist Hospital	San Antonio	Texas
United States	Deaconess Medical Center	Spokane	Washington
United States	St. John's Hospital - Prairie Heart Institute	Springfield	Illinois
United States	St. Joseph's Medical Center	Stockton	California
United States	Medical College of Ohio	Toledo	Ohio
United States	Washington Hospital Center	Washington	District of Columbia
United States	Pinnacle Health at Harrisburg Hospital	Wormleysburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	peri-procedural (within 30 days of procedure) death, stroke, Q-wave myocardial infarction		Within 30 days of Procedure	Yes
Primary	late ipsilateral stroke or death due to neurologic events from 31 days up to and including twelve-month follow-up.		1 year	Yes
Secondary	Peri-procedural morbidity and mortality		Within 30 Days of procedure	Yes
Secondary	FilterWire EX and EZ System technical success		Post procedure	Yes
Secondary	Carotid Wallstent technical success		Post Procedure	Yes
Secondary	system technical success		Post Procedure	Yes
Secondary	angiographic success		Post Procedure	Yes
Secondary	procedural success		Post Procedure	Yes
Secondary	30-day clinical success		30 days post procedure	Yes
Secondary	peri-procedural overall morbidity		30 days post procedure	Yes
Secondary	one-year clinical success		1 Year post procedure	Yes
Secondary	late stroke, transient ischemic attack (TIA) and death.		1 year post procedure	Yes