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
This study was a multi-center, prospective, single arm, open-label study to assess safety and efficacy
outcomes of stenting with distal protection in the treatment of obstructive carotid artery disease during peri-approval/initial commercialization phase of Cordis' carotid program in relation to the outcomes of the SAPPHIRE clinical trial.
Study Population Description
This device is indicated for use in conjunction with the ANGIOGUARD XP Emboli Capture Guidewire
for the treatment of patients at high risk for adverse events from carotid endarterectomy (defined in the IFU) who require carotid revascularization and meet the criteria outlined: 1) Patients with neurological symptoms and >50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and >80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND 2) Patients must have a vessel diameter of 4-9mm at the target lesion. The vessel distal to the target lesion must be within the range of 3mm and 7.5mm to allow for placement of the ANGIOGUARD XP Emboli Capture Guidewire. The study population was designed to be comprised of up to 1500 patients with de novo atherosclerotic or post-endarterectomy restenotic obstructive lesions in native carotid arteries.
Sample Size
1500 patients, 112 sites
Data Collection
This study was a non-inferiority trial designed to test the primary endpoint, major adverse events
at 30 days, against an established performance criteria (9.3%).
Followup Visits and Length of Followup
Clinical follow-up was conducted at 30 days and conducted via telephone contact at 1-year post-procedure.
The assessment at 30 days included a neurological examination and an evaluation of any adverse events. At 1-year post-procedure an evaluation of any adverse events was performed.
Final Study Results
Actual Number of Patients Enrolled
1472 patients
Actual Number of Sites Enrolled
80 sites
Patient Followup Rate
84%
Final Safety Findings
The rate of the primary endpoint, major adverse events, at 30 days post-procedure is 5.0%
(74/1492) with a 95% confidence interval (CI) 3.9%, 6.2%. The rate of major adverse events at 360 days post-procedure is 11.6% (173/1492) with 95% CI [10.0%, 13.3%] for all intent-to-treat patients. The 30 day rate of 5.0% is below the SAPPHIRE rate of 6.3% and the OPC rate of 9.3%.
Study Strengths and Weaknesses
Strengths: The sponsor utilized the peri-approval approach to rapidly start up this study. Weaknesses: The
sponsor does not provide a context within which to interpret the 360 day rate, therefore it is difficult to assess whether the device is safe at 360 days post-implant.
Recommendations for Labeling Changes
Updated labeling requested from sponsor to reflect 30 day major adverse event rates.
