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	P250033 / PAS001
Date Original Protocol Accepted	04/02/2026
Date Current Protocol Accepted	04/02/2026
Study Name	Continued Follow-up of the IDE Study Subjects
Device Name	NEXUS Aortic Arch Stent Graft System
Clinical Trial Number(s)	NCT04471909
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	New Data Collection
Comparison Group	No Control
Analysis Type	Descriptive
Study Population	Adult: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives	The TRIOMPHE study is a prospective, non-randomized, multi-center clinical investigation designed to evaluate the safety and effectiveness of the NEXUS™ Aortic Arch Stent Graft System for the endovascular treatment of thoracic aortic lesions involving the aortic arch, including chronic dissections, aneurysms, penetrating aortic ulcers (PAU), and intramural hematoma (IMH). It involves continued follow up of IDE subjects.
Study Population	The study enrolled subjects who have thoracic aortic lesions involving the aortic arch.
Sample Size	94 subjects were enrolled in the IDE
Key Study Endpoints	There were two co-primary endpoints, both assessed through 30 days: (1) Device Technical Failure, which captures failure to deliver/deploy/retrieve device components, device occlusion, failed exclusion of the primary entry tear, and unanticipated surgical or interventional procedures; and (2) Clinical Failure, defined as early mortality or occurrence of at least one major adverse event (MAE) — including disabling stroke, permanent paralysis/paraplegia, new-onset renal failure requiring permanent dialysis, aortic rupture, or development of new dissections requiring intervention — through 30 days of the Phase 1 and Index Procedures. Secondary endpoints include a broad range of safety and effectiveness measures assessed at 30 days and at 6, 12, 24, 36, 48, and 60 months, such as all-cause mortality, lesion-related mortality, neurological events, endoleaks, migration, aortic enlargement, false lumen patency, and device integrity.
Follow-up Visits and Length of Follow-up	All implanted subjects will be followed for 60 months (5 years) post-index procedure.

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	04/02/2027
2 year report	04/01/2028
3 year report	04/01/2029
4 year report	04/01/2030

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