Post-Approval Studies (PAS) Database

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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Continued Follow-up of the IDE Study Subjects

General
Study Status	Study Pending
Application Number / Requirement Number	P200030 S014/ PAS001
Date Original Protocol Accepted	04/05/2024
Date Current Protocol Accepted
Study Name	Continued Follow-up of the IDE Study Subjects
Device Name	GORE®1 EXCLUDER® Conformable AAA Endoprosthesis (CEXC), GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC)
Clinical Trial Number(s)	NCT02489539
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 Excluder Conformable AAA Endoprosthesis (EXCC). The study consists of long-term follow-up of the premarket cohort. The study was designed to evaluate the safety and effectiveness of the EXCC device for the treatment of infrarenal AAA including patients with short and/or angulated aortic necks. The pivotal study was comprised of two substudies, the Short Neck (SN) substudy and High Neck Angulation (HNA) substudy. Data from the HNA substudy were the basis for the P200030/S014 approval decision.
Study Population	Patients with abdominal aortic aneurysms having aortic neck angulation up to 90° and infrarenal aortic neck length >10 mm.
Sample Size	A total of 175 subjects were enrolled in the study across the SN and HNA substudies. Ninety-five subjects were enrolled in the HNA substudy and remaining subjects will be followed.
Key Study Endpoints	Major 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	5 years

Continued Follow-up of the IDE Study Subjects Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
1 year report	04/05/2025
2 year report	04/05/2026
3 year report	04/05/2027
4 year report	04/04/2028

Contact Us

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

Additional Resources

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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background