N/A
Completed N=80
Zenith® p-Branch® Endovascular Graft Pivotal Study
Aortic Aneurysm Abdominal
Source: ClinicalTrials.gov NCT02396199 ↗
Enrolled (actual)
80
Serious AEs
31.3%
Results posted
Oct 2022
Primary outcomePrimary: Treatment Success Proportion — 0.917 Proportion of participants — p=0.006
Summary
The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium iCAST™ covered stents in the treatment of abdominal aortic aneurysms.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Success Proportion |
0.917 | 0.006 sig |
Eligibility Criteria
Inclusion Criteria
- Pararenal or juxtarenal AAA ≥5.0 cm in diameter or 2 times the normal aortic diameter
- Pararenal or juxtarenal AAA with history of growth ≥0.5 cm/year
- Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic diameter that is deemed to be at risk for rupture based upon physician interpretation
Exclusion Criteria
- Age <18 years
- Life expectancy <2 years
- Pregnant, breast-feeding, or planning on becoming pregnant within 60 months
- Inability or refusal to give informed consent by the patient or a legally authorized representative
- Unwilling or unable to comply with the follow-up schedule
- Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.)
- 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 (NCT02396199). 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.