Aorto-iliac 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 PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Zenith® Connection Endovascular Stent/ConnectSX™ covered stent in the treatment of aorto-iliac and iliac aneurysms.
Interventions
DEVICEEndovascular repair for aortoiliac or iliac aneurysms.
Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Zenith® Connection Endovascular Covered Stent/ConnectSX™ and the Zenith® Flex AAA Endovascular Graft.
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
* An aortoiliac or iliac aneurysm of appropriate size * Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac 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 * Unsuitable arterial anatomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients That Are Free From Patency-related Intervention | 6 Months | Patency-related intervention is defined as: Secondary intervention to treat a \> 60% stenosis of the internal iliac artery (as identified through CT, angiography, or duplex ultrasound and confirmed by core laboratory) associated with clinical symptoms. Of note, this not only includes patients with internal iliac artery stenosis following successful placement of the Zenith® Branch Endovascular Graft-Iliac Bifurcation and ConnectSX™, but also any cases of technical failure resulting in occlusion of the internal iliac artery during the initial implant procedure that require secondary intervention for associated clinical symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zenith® Iliac Branch System Zenith® Branch Endovascular Graft-Iliac Bifurcation System is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Device not placed | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Still be eligible for follow-up | 33 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Zenith® Iliac Branch System |
|---|---|
| Age, Continuous | 69 years STANDARD_DEVIATION 7.1 |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 7 / 40 |
| serious Total, serious adverse events | 7 / 40 |
Outcome results
Primary
Patients That Are Free From Patency-related Intervention
Patency-related intervention is defined as: Secondary intervention to treat a \> 60% stenosis of the internal iliac artery (as identified through CT, angiography, or duplex ultrasound and confirmed by core laboratory) associated with clinical symptoms. Of note, this not only includes patients with internal iliac artery stenosis following successful placement of the Zenith® Branch Endovascular Graft-Iliac Bifurcation and ConnectSX™, but also any cases of technical failure resulting in occlusion of the internal iliac artery during the initial implant procedure that require secondary intervention for associated clinical symptoms.
Time frame: 6 Months
Population: Of the 37 patients available for analysis at 6 months, data was available for 34 patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device Implant | Patients That Are Free From Patency-related Intervention | 33 participants |