Aortic Aneurysm Abdominal
Conditions
Keywords
Abdominal aortic aneurysm, Endovascular, Juxtarenal, Pararenal, Fenestrated
Brief summary
The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium iCAST™ covered stents in the treatment of abdominal aortic aneurysms.
Interventions
DEVICEZenith® p-Branch® in combination with the Atrium iCAST™ covered stents
Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
Sponsors
Cook Research 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 or 2 times the normal aortic diameter * Pararenal or juxtarenal AAA with history of growth ≥0.5 cm/year * Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic diameter that is deemed to be at risk for rupture based upon physician interpretation
Exclusion criteria
* Age \<18 years * Life expectancy \<2 years * Pregnant, breast-feeding, or planning on becoming pregnant within 60 months * 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 * Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.) * 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 |
|---|---|---|
| Treatment Success Proportion | 12 months | Technical success and freedom from type 1 and type 3 endoleaks which require intervention, aneurysm growth, related SAE's, and related major complications |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Endovascular Endovascular treatment using the Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents: Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta. | 80 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 4 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Endovascular |
|---|---|
| Age, Continuous | 71.7 years STANDARD_DEVIATION 7.6 |
| Race/Ethnicity, Customized Black(origins of Africa) | 7 Participants |
| Race/Ethnicity, Customized White(origins of Europe, Middle East, or North Africa) | 72 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 80 |
| other Total, other adverse events | 8 / 80 |
| serious Total, serious adverse events | 25 / 80 |
Outcome results
Primary
Treatment Success Proportion
Technical success and freedom from type 1 and type 3 endoleaks which require intervention, aneurysm growth, related SAE's, and related major complications
Time frame: 12 months
Population: Eight patients had incomplete outcome data either due to death, loss to follow-up, missed visits, or any combination thereof.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Endovascular | Treatment Success Proportion | 0.917 Proportion of participants |
p-value: 0.006Fisher Exact