Aortoiliac Aneurysms, Iliac Aneurysms
Conditions
Keywords
Zenith aortoiliac aneurysm, Iliac aneurysm, Branch, Connections, Endovascular graft, Graft-iliac bifurcation, Aneurysm, Vascular Diseases, Cardiovascular Diseases
Brief summary
The purpose of this extended study is to evaluate the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in patients in a treatment of aortoiliac and iliac aneurysms.
Interventions
Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation.
DEVICEAtrium iCAST™
Implantation of Atrium iCAST
DEVICEZenith® Flex AAA Endovascular Graft
Implantation of the Zenith Flex Endovascular Graft
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
* An aortioiliac or iliac aneurysm * An unsuitable distal sealing site for a traditional Zenith iliac leg graft within the common lilac artery
Exclusion criteria
* Less than 18 years of age * Inability or refusal to give informed consent * Disease considerations that would compromise patient safety or study outcomes * Pregnant, breast-feeding or planning on becoming pregnant prior to completion of the study * Unwilling or unable to comply with the follow-up schedule * Simultaneously participating in another investigative device or drug study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients With Freedom From Patency-related Intervention Defined as a Secondary Intervention to Treat a > 60 % Stenosis of the Internal Iliac Artery Associated With Clinical Symptoms. | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Morbidity (i.e., Morbidity Index) | 30 days | Morbidity index based on a composite endpoint of 31 pre-specified measure elements in seven categories (i.e., cardiovascular, pulmonary, renal, bowel, wound, neurologic, and vascular). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zenith® Branch Endovascular Graft-Iliac Bifurcation Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft
Zenith® Branch Endovascular Graft-Iliac Bifurcation,: Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation.
Atrium iCAST™: Implantation of Atrium iCAST
Zenith® Flex AAA Endovascular Graft: Implantation of the Zenith Flex Endovascular Graft | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 4 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Zenith® Branch Endovascular Graft-Iliac Bifurcation |
|---|---|
| Age, Continuous | 67.8 years STANDARD_DEVIATION 9 |
| Race/Ethnicity, Customized African American or Black | 3 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants |
| Race/Ethnicity, Customized White | 35 Participants |
| Region of Enrollment United States | 40 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 40 |
| other Total, other adverse events | 15 / 40 |
| serious Total, serious adverse events | 26 / 40 |
Outcome results
Primary
Number of Patients With Freedom From Patency-related Intervention Defined as a Secondary Intervention to Treat a > 60 % Stenosis of the Internal Iliac Artery Associated With Clinical Symptoms.
Time frame: 6 months
Population: One patient died prior to the 6-month visit and thus did not contribute data to the primary outcome. This death was related to a pre-existing condition.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zenith® Branch Endovascular Graft-Iliac Bifurcation | Number of Patients With Freedom From Patency-related Intervention Defined as a Secondary Intervention to Treat a > 60 % Stenosis of the Internal Iliac Artery Associated With Clinical Symptoms. | 39 Participants |
Secondary
Freedom From Morbidity (i.e., Morbidity Index)
Morbidity index based on a composite endpoint of 31 pre-specified measure elements in seven categories (i.e., cardiovascular, pulmonary, renal, bowel, wound, neurologic, and vascular).
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zenith® Branch Endovascular Graft-Iliac Bifurcation | Freedom From Morbidity (i.e., Morbidity Index) | 34 Participants |