N/A
Completed N=28
Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Clinical Study
Aortic Aneurysm, Abdominal
Source: ClinicalTrials.gov NCT01652235 ↗
Enrolled (actual)
28
Serious AEs
14.3%
Results posted
Sep 2024
Primary outcomePrimary: Technical Success: — 28 participants
Summary
The Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Single-Center Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic aneurysms.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Technical Success: |
28 | — |
| PRIMARY Procedural Success |
25 | — |
| PRIMARY Treatment Success |
23 | — |
Eligibility Criteria
Inclusion Criteria
- Abdominal aortic aneurysm > 5.0 cm or 2 times the normal aortic diameter
- Abdominal aortic aneurysm with history of growth > 0.5 cm in 6 months
- Penetrating juxtarenal aortic ulcer > 10 mm in depth and 20 mm in diameter
Exclusion Criteria
- Age < 18 years
- Life expectancy < 2 years
- Pregnant or breast feeding
- Inability or refusal to give informed consent
- Unwilling or unable to comply with the follow-up schedule
- Additional medical restrictions as specified in the Clinical Investigation Plan
- Additional anatomical restrictions as specified in the Clinical Investigation Plan
Data sourced from ClinicalTrials.gov (NCT01652235). 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.