Abdominal Aortic Aneurysm (AAA), Aorto-iliac Aneurysm, Juxtarenal Aneurysm
Conditions
Keywords
Aneurysm, Aortic Aneurysm, Iliac Aneurysm, Aortic Aneurysm, Abdominal, Vascular Diseases, Cardiovascular Diseases, Aortic Diseases
Brief summary
This post-market study is approved by the US FDA to evaluate the long-term safety and performance of the Zenith® Fenestrated AAA Endovascular Graft.
Interventions
The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneursyms having morphology suitable for endovascular repair
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
* abdominal aortic and aortoiliac aneursyms with a diameter greater than or equal to 5 cm * aortic or aortoiliac aneurysm with a history of growth greater than or equal to 0.5 cm per year, or clinical indication for AAA repair
Exclusion criteria
* proximal neck less than 4mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal * renal artery stenosis greater than 50 percent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success : AAA Related Mortality | 5 years | patients treated with the Zenith® Fenestrated AAA Endovascular Graft will have a rate of aneurysm-related mortality at 5 years that meets a performance goal of 18% , |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zenith® Fenestrated AAA Endovascular Graft The Zenith® Fenestrated AAA Endovascular Graft is a modular system consisting of three components, a proximal body graft, a distal bifurcated body graft and one iliac leg. Additional ancillary components (main body extensions, iliac leg extensions, converters, and occluders) are available. The Zenith® Alignment Stent is a balloon-expandable stent that can be deployed through scallops or fenestrations in a Zenith® Fenestrated AAA Endovascular Graft into branch vessels of the aorta. | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Zenith® Fenestrated AAA Endovascular Graft |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 16 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 70.1 years STANDARD_DEVIATION 6.9 |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized White | 19 Participants |
| Race/Ethnicity, Customized White; Hispanic or Latino | 1 Participants |
| Region of Enrollment United States | 21 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 21 |
| other Total, other adverse events | 13 / 21 |
| serious Total, serious adverse events | 11 / 21 |
Outcome results
Primary
Treatment Success : AAA Related Mortality
patients treated with the Zenith® Fenestrated AAA Endovascular Graft will have a rate of aneurysm-related mortality at 5 years that meets a performance goal of 18% ,
Time frame: 5 years
Population: patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zenith® Fenestrated AAA Endovascular Graft | Treatment Success : AAA Related Mortality | 0 Participants |