N/A Completed N=120 Treatment

Zenith(R) Low Profile AAA Endovascular Graft Clinical Study

Abdominal Aortic Aneurysms · Iliac Aneurysms · Aorto-iliac Aneurysms

Source: ClinicalTrials.gov NCT00833924 ↗

Enrolled (actual)

120

Serious AEs

52.5%

Results posted

Jan 2016

Primary outcomePrimary: Patients With Major Adverse Events (MAE) — 1 participants — p=<0.01

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.

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.