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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


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
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