Clinical trial NCT00316108: Boston Scientific Embolic Protection, Inc. (EPI): A Carotid Stenting Trial for High-Risk Surgical Patients (BEACH)
Official title: Boston Scientific EPI: A Carotid Stenting Trial for High-Risk Surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Artery Diseases
Stroke
Cerebral Arteriosclerosis
Keywords: Carotid
Carotid Artery Stenting
Stent
Carotid Endarterectomy
Stroke
Transient Ischemic Attack
Stenosis
Atherosclerotic Disease
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2006-04-20
Enrollment: 747
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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.

Primary outcomes:
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
timeFrame: 1 year
measure: peri-procedural (within 30 days of procedure) death, stroke, Q-wave myocardial infarction
timeFrame: Within 30 days of Procedure
measure: late ipsilateral stroke or death due to neurologic events from 31 days up to and including twelve-month follow-up.
timeFrame: 1 year
Secondary outcomes:
measure: Peri-procedural morbidity and mortality
timeFrame: Within 30 Days of procedure
measure: FilterWire EX and EZ System technical success
timeFrame: Post procedure
measure: Carotid Wallstent technical success
timeFrame: Post Procedure
measure: system technical success
timeFrame: Post Procedure
measure: angiographic success
timeFrame: Post Procedure
measure: procedural success
timeFrame: Post Procedure
measure: 30-day clinical success
timeFrame: 30 days post procedure
measure: peri-procedural overall morbidity
timeFrame: 30 days post procedure
measure: one-year clinical success
timeFrame: 1 Year post procedure
measure: late stroke, transient ischemic attack (TIA) and death.
timeFrame: 1 year post procedure
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Bapatist Medical Center
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Arizona Heart Institute
state: Arizona
city: Phoenix
country: United States
facility: St. Joseph's Hospital & Medical Center
state: Arizona
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital
state: California
city: Stockton
country: United States
facility: St. Joseph's Medical Center
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Ft. Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Medical Center
state: Florida
city: Miami
country: United States
facility: University of Miami School of Medicine - Jackson Memorial Hospital
state: Florida
city: Miami
country: United States
facility: Miami Cardiac and Vascular Institute
state: Florida
city: Plantation
country: United States
facility: Northwest Medical Center
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Atlanta
country: United States
facility: St. Joseph's Hospital of Atlanta/American Cardiovascular Research Institute
state: Georgia
city: Chicago
country: United States
facility: Rush Presbyterian-St. Luke's Medical Center
state: Illinois
city: Peoria
country: United States
facility: St. Francis Medical Center
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital - Prairie Heart Institute
state: Illinois
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Hyannis
country: United States
facility: Cape Cod Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University- Detroit Medical Center
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Kansas City
country: United States
facility: St. Luke's Hospital of Kansas City
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: Kaleida Health/Millard Fillmore Hospital
state: New York
city: New York
country: United States
facility: Lenox Hill Heart and Vascular Institute
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital/Columbia Vascular Interventional Radiology
state: New York
city: Rochester
country: United States
facility: Strong Memorial Hospital
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic & Foundation
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Toledo
country: United States
facility: Medical College of Ohio
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Philadelphia
country: United States
facility: Hahnemann University/ Tenet Healthcare Corporation
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC-Shadyside Hospital Pittsburgh Vascular Institute
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health at Harrisburg Hospital
state: Pennsylvania
city: Columbia
country: United States
facility: Providence Hospital South Carolina Heart Center
state: South Carolina
city: Knoxville
country: United States
facility: Baptist Hospital of East Tennessee
state: Tennessee
city: Nashville
country: United States
facility: Skyline Medical Center/ Howell Allen Clinic
state: Tennessee
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital Texas Heart Institute
state: Texas
city: Houston
country: United States
facility: University of Texas-Houston Medical School
state: Texas
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: San Antonio
country: United States
facility: Baptist Hospital
state: Texas
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
city: Richmond
country: United States
facility: St. Mary's Hospital
state: Virginia
city: Spokane
country: United States
facility: Deaconess Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: Ochsner Health System
name: Christopher White, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lenox Hill Heart and Vascular Institute
name: Sriram Iyer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Scientific Corporation
name: Pamela G Grady, Ph.D
role: STUDY_DIRECTOR
References:
citation: 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.