N/A
Completed N=42
Zenith(R) Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Clinical Study
Abdominal Aortic Aneurysms · Aorto-iliac Aneurysms · Juxtarenal Aneurysms
Source: ClinicalTrials.gov NCT00875563 ↗
Enrolled (actual)
42
Serious AEs
9.5%
Results posted
Sep 2015
Primary outcomePrimary: Number of Participants With Treatment Success — 39 participants — p=0.02
Summary
The Zenith(R) Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith(R) Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Success |
39 | 0.02 sig |
Eligibility Criteria
Inclusion Criteria
- Abdominal aortic and aortoiliac aneurysms with diameter greater than or equal to 5 cm
Exclusion Criteria
- Proximal neck less than 4 mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal
- Renal artery stenosis greater than 50 percent
Data sourced from ClinicalTrials.gov (NCT00875563). 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.