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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Longterm & CASES Studies


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General
Application Number P030047 / PAS001
Current Plan Approved 09/22/2006
Study Name Longterm & CASES Studies
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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%).
Follow-up Visits and Length of Follow-up 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
Interim Safety Information Study completed, see final results.
Number of Patients 1472 patients
Number of Sites 80 sites
Follow-up Rate 84%
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%.
Strengths & 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.
Label Changes Updated labeling requested from sponsor to reflect 30 day major adverse event rates.


Longterm & CASES Studies Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year final report (CASES Study) 06/07/2007 07/17/2007 On Time


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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