Study Assessing Safety and Effectiveness of Perivisceral Aortic Aneurysm Treatment With the Zenith® Fenestrated AAA Endovascular Graft and the Zenith® p-Branch® and the Effects on Organ and Extremity Perfusion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cook Research Incorporated
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- Technical Success:
Study Overview
Brief Summary
The Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Single-Center Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic aneurysms.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Abdominal aortic aneurysm > 5.0 cm or 2 times the normal aortic diameter
- •Abdominal aortic aneurysm with history of growth > 0.5 cm in 6 months
- •Penetrating juxtarenal aortic ulcer > 10 mm in depth and 20 mm in diameter
Exclusion Criteria
- •Age < 18 years
- •Life expectancy < 2 years
- •Pregnant or breast feeding
- •Inability or refusal to give informed consent
- •Unwilling or unable to comply with the follow-up schedule
- •Additional medical restrictions as specified in the Clinical Investigation Plan
- •Additional anatomical restrictions as specified in the Clinical Investigation Plan
Outcomes
Primary Outcomes
Technical Success:
Time Frame: Immediately post graft deployment
Successful access of the aneurysm site and deployment of the Zenith® Fenestrated AAA Endovascular Graft or the Zenith® p-Branch™ in the intended location. The endovascular graft and all vessels targeted with fenestrations must be patent at the time of deployment completion as evidenced by intraoperative angiography
Procedural Success
Time Frame: Within 30 days post graft deployment
Technical Success, with all of the following at post-procedure (within 30 days): * No type I or type III endoleaks; * No procedure related serious adverse events or major complications; * Patency of the endovascular graft and all vessels targeted with fenestrations as evidenced by CT scan, angiography or by duplex ultrasound in those patients experiencing renal failure or otherwise unable to undergo contrast enhanced CT scan.
Treatment Success
Time Frame: 12 months
Procedural Success, with all of the following at 12 months: * No type I or type III endoleaks; * No serious adverse events or major complications; * No aneurysm enlargement greater than 0.5 cm; * Patency of the endovascular graft and all vessels targeted with fenestrations as evidenced by CT scan, angiography or by duplex ultrasound in those patients experiencing renal failure or otherwise unable to undergo contrast enhanced CT scan.
Secondary Outcomes
No secondary outcomes reported