Evaluation of the Safety and Effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Abdominal Aortic Aneurysms
- Sponsor
- Cook Group Incorporated
- Enrollment
- 120
- Locations
- 27
- Primary Endpoint
- Patients With Device Failures
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief 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.
Investigators
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
Outcomes
Primary Outcomes
Patients With Device Failures
Time Frame: 12-month
Device success at 12-month is defined as: Technical Success (successful access of the aneurysm site, deployment of the graft in the intended location, and patency of the graft at the time of deployment completion intra-operatively), and freedom from the following at 12 months: Type I or type III endoleaks requiring re-intervention, Aneurysm rupture or conversion to open surgical repair, and Aneurysm enlargement greater than 0.5 cm.
Patients With Major Adverse Events (MAE)
Time Frame: 30-day
MAE is defined as any occurrence of all-cause death, Q-wave myocardial infarction (MI), renal failure requiring dialysis, paralysis, stroke, bowel ischemia, or re-intubation.