Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Clinical Study
- Conditions
- Aortic Aneurysm, Abdominal
- Interventions
- Device: Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft
- Registration Number
- NCT01652235
- Lead Sponsor
- Cook Research Incorporated
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Endovascular Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft
- Primary Outcome Measures
Name Time Method Technical Success: 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 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 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 Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Mount Sinai-West
🇺🇸New York, New York, United States
New York Presbyterian Hospital System
🇺🇸New York, New York, United States