N/A
N=62
Zenith® Low Profile AAA Endovascular Graft
Abdominal Aortic Aneurysms · Iliac Aneurysms · Aortoiliac Aneurysms
Bottom Line
View on ClinicalTrials.gov: NCT02535065 ↗Enrolled (actual)
62
Serious AEs
79.0%
Results posted
Jun 2018
Primary outcome: Primary: Number of Patients Without Major Adverse Events Within 30 Days — 62 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Zenith Low Profile AAA Endovascular Graft and ancillary components (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cook Research Incorporated
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Without Major Adverse Events Within 30 Days |
62 | — |
| PRIMARY Number of Patients With Device Success |
57 | — |
Summary
The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft used in conjunction with the Zenith® Spiral-Z® AAA Iliac Leg Graft to treat abdominal aortic, aortoiliac, and iliac aneurysms.
Eligibility Criteria
Inclusion Criteria
- Subject has at least one of the following
- Aortic or aortoiliac aneurysm
- Iliac aneurysm
- Aneurysm with a history of growth
Exclusion Criteria
- Less than 18 years of age
- Inability or refusal to give informed consent
- Disease considerations that would compromise patient safety or study outcomes
- Pregnant of breastfeeding or planning on becoming pregnant with 60 months
- Unwilling to comply with the follow-up schedule
Data sourced from ClinicalTrials.gov (NCT02535065). 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.