N/A
N=120
Zenith(R) Low Profile AAA Endovascular Graft Clinical Study
Abdominal Aortic Aneurysms · Iliac Aneurysms · Aorto-iliac Aneurysms
Bottom Line
View on ClinicalTrials.gov: NCT00833924 ↗Enrolled (actual)
120
Serious AEs
52.5%
Results posted
Jan 2016
Primary outcome: Primary: Patients With Major Adverse Events (MAE) — 1 participants — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Zenith(R) Low Profile AAA Endovascular Graft (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cook Group Incorporated
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients With Major Adverse Events (MAE) |
1 | <0.01 sig |
| PRIMARY Patients With Device Failures |
1; 2 | <0.01 sig |
Summary
The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft to treat abdominal aortic, aorto-iliac, and iliac aneurysms.
Eligibility Criteria
Inclusion Criteria
- Abdominal aortic, aortoiliac, and iliac aneurysms of appropriate size
- Vessels suitable for endovascular access and aneurysm repair
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
- Unsuitable arterial anatomy
Data sourced from ClinicalTrials.gov (NCT00833924). 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.