Abdominal Aortic Aneurysm, Aorto-iliac Aneurysm, Iliac Aneurysm
Conditions
Keywords
aortic aneurysm, iliac aneurysm, endovascular procedures
Brief summary
A prospective study conducted in Japan to collect confirmatory peri-operative and 30-day information on use of the Zenith LP AAA Graft.
Interventions
DEVICEZLP
ZLP Graft
Sponsors
Cook Group Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Abdominal aortic, aorto-iliac, and iliac aneurysms of appropriate size * Vessels suitable for endovascular access and aneurysm repair
Exclusion criteria
* Less than 20 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 |
|---|---|
| Composite rate of adverse clinical/device events | During (day 1) and after implantation through 12 months |
Countries
Japan
Outcome results
None listed