In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
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 Description
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
Data Collection
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.
Followup Visits and Length of Followup
Patients will be assessed at 30 days, and annually to 3 years.
Final Study Results
Actual Number of Patients Enrolled
747 patients
Actual Number of Sites Enrolled
47 sites
Patient Followup 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 and 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.
