f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Cont f/u of the IDE Study Subjects


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General
Study Status Ongoing
Application Number /
Requirement Number		 P200030 / PAS001
Date Original Protocol Accepted 12/22/2020
Date Current Protocol Accepted  
Study Name Cont f/u of the IDE Study Subjects
Device Name Gore Excluder Conformable AAA Endoprosthesis (CEXC)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives The purpose of the post approval study is to evaluate the long-term safety and effectiveness of the Gore Excluder Conformable AAA Endoprosthesis (EXCC). It is a prospective, multi-center, single-arm clinical study. It involves the long-term follow-up of the premarket cohort.
Study Population The study population is patients with an infrarenal abdominal aortic aneurysm who met the study selection criteria.
Sample Size A total of 80 subjects were enrolled in the study and remaining subjects will be followed.
Key Study Endpoints Serious adverse events, all-cause mortality, aneurysm-related mortality, aneurysm rupture, secondary interventions, conversion to open surgery, losses of device integrity, device occlusions, stenosis or kink, aneurysm enlargement (greater than or equal to 5 mm), stent graft migration (greater than or equal to 10 mm), all types of endoleaks, and other device-related events.
Follow-up Visits and Length of Follow-up Subjects will be followed for 5 years.


Cont f/u of the IDE Study Subjects Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 12/22/2021 12/14/2021 On Time
2 year report 12/22/2022 01/05/2023 Overdue/Received
final report 06/22/2024    


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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