|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P050019 / PAS002 |
| Date Original Protocol Accepted |
10/23/2008
|
| Date Current Protocol Accepted |
10/23/2008
|
| Study Name |
BEACH STUDY
|
| Device Name |
CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The BEACH Trial was a prospective, single-arm, multi-center trial intended to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) Carotid WALLSTENT Endoprosthesis in conjunction with the FilterWire EX/EZ System in selected high-risk surgical patients with stenosis of the carotid artery. Success of this trial was assessed by comparison to an OPC representative of similar patients treated with CEA. A maximum of six hundred eighty (680) patients with carotid stenosis at high risk for complications associated with CEA who met specific enrollment criteria were to be evaluated in the Pivotal portion of the trial and a maximum of 96 for the Bilateral Registry. Clinical follow-up for all patients was planned to occur at 1 month, 6 month, and 12 months and annually thereafter up to 60 months post index procedure. Preliminary examinations included angiography, ultrasound, and computed tomography (CT) or magnetic resonance imaging (MRI). The procedural evaluation included baseline angiography. Follow-up examinations included carotid duplex ultrasound imaging. If for any reason carotid ultrasound was not possible, an angiographic examination was required. A complete lab study was performed after the patient qualified for entry into the clinical trial.
|
| Study Population |
The Carotid WALLSTENT Monorail Endoprosthesis, used in conjunction with the Boston Scientific embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy due to either anatomic or co-morbid conditions who require carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease.
|
| Sample Size |
747 patients, 47 sites
|
| Key Study Endpoints |
The primary endpoint (defined as the composite of Non Q-wave myocardial infarction within the 24 hours following carotid stenting; death, stroke and Q-wave myocardial infarction within 30 days; and ipsilateral stroke or death due to neurological events from 31 days to one year) was compared to the weighted performance criteria.
|
| Follow-up Visits and Length of Follow-up |
Patients will be assessed at 30 days, and annually to 3 years.
|
| Interim or Final Data Summary |
| Interim Results |
Study completed, see final results.
|
| Actual Number of Patients Enrolled |
747 patients
|
| Actual Number of Sites Enrolled |
47 sites
|
| Patient Follow-up Rate |
90%
|
| Final Safety Findings |
The 3 year death, stroke and myocsrdial infarction rates were 5.6%, 2.3%, and 0.3%. These rates declined from their peaks which were seen at one year: 7.7%, 8.3%, and 2.6% respectively.
|
| Study Strengths & Weaknesses |
Strengths: The sponsor did complete this study within a reasonable period of time (2 years after device approval), eventhough there was not a study timeline. Weaknesses: The sponsor notes that 315 of the 480 patients were evaluable at 3 years. There were 84 deaths in the study. If the deaths are not included in the lost-to-follow-up rate than the 3 year follow-up was 83% (399/480). This is lower than would be expected for an IDE study however, it is an acceptable rate.
|
| Recommendations for Labeling Changes |
Labeling changes were not recommended.
|
