Abdominal Aortic Aneurysm, Aortic Aneurysm
Conditions
Keywords
Abdominal aortic aneurysm, Endovascular, Fenestration, Juxtarenal, Off-the-shelf, Pararenal
Brief summary
The Zenith® p-Branch™: Single-Center Study is a clinical trial approved by Swedish Regulatory Authority to study the safety and effectiveness of the Zenith® p-Branch™ in the treatment of abdominal aortic aneurysms.
Interventions
DEVICEEndovascular treatment (Zenith® p-Branch™ endovascular graft)
Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
Sponsors
Cook Group Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pararenal or juxtarenal AAA \>5.0 cm in diameter * Pararenal or juxtarenal AAA with history of growth \>0.5 cm/year
Exclusion criteria
* Age \< 18 years * Life expectancy \< 2 years * Pregnant or breast feeding * Inability or refusal to give informed consent by the patient or a legally authorized representative * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | Up to 5 years | Technical success is described as: 1) successful access of the aneurysm site, 2) successful deployment of the Zenith® p-Branch™ endovascular graft in the intended location, 3) Zenith® p-Branch-™ endovascular graft is patent at deployment completion as evidenced by intraoperative angiography, and 4) all vessels targeted with a fenestration are patent at deployment completion as evidenced by intraoperative angiography. |
Countries
Sweden
Outcome results
None listed