N/A Completed N=21 Treatment

Fenestrated AAA Endovascular Graft Post-Approval Study

Abdominal Aortic Aneurysm (AAA) · Aorto-iliac Aneurysm · Juxtarenal Aneurysm

Source: ClinicalTrials.gov NCT01990950 ↗

Enrolled (actual)

Serious AEs

52.4%

Results posted

Sep 2021

Primary outcomePrimary: Treatment Success : AAA Related Mortality — 0 Participants

Summary

This post-market study is approved by the US FDA to evaluate the long-term safety and performance of the Zenith® Fenestrated AAA Endovascular Graft.

Outcome Measures

Outcome	Result	p-value
PRIMARY Treatment Success : AAA Related Mortality	—	—

Eligibility Criteria

Inclusion Criteria

abdominal aortic and aortoiliac aneursyms with a diameter greater than or equal to 5 cm
aortic or aortoiliac aneurysm with a history of growth greater than or equal to 0.5 cm per year, or clinical indication for AAA repair

Exclusion Criteria

proximal neck less than 4mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal
renal artery stenosis greater than 50 percent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01990950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.