Aortic Aneurysm, Abdominal
Conditions
Brief summary
The purpose of this study is to determine if it is safe and effective to use the TALENT AAA Stent Graft System as a treatment for AAAs in patients who are also candidates for conventional surgical aneurysm repair.
Interventions
DEVICEEndovascular Repair of Abdominal Aortic Aneurysms Using TALENT AAA Stent Graft System
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient has one of the following: * Aneurysm \>4 cm in diameter, or an aneurysm that has increased in size by 0.5 cm in the last 6-months * Aneurysm is 1.5 times larger than the diameter of the normal infrarenal aorta or symptomatic * Aneurysm is saccular * Penetrating ulcer 2. Patient's vascular dimensions must be in the range that can be safely treated with the stent graft available to the physician at the time of the procedure. 3\. Patient has endovascular access to the aneurysmal site with the Introducer Sheath or Delivery Catheter of the appropriate ize device chosen for treatment. 4\. Patient has anatomic characteristics suitable for endovascular repair. 5. Patient has an immediate life-threatening disease of the abdominal aorta in which there is a reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment. 6\. Patient is American Society of Anesthesiology (ASA) grade 1 through 4. 7. Patient is able and willing to comply with 3 month, 6 month, 1 year and every year thereafter post treatment follow-up requirements. 8\. Patient or patient's legal representative understands and has signed an Informed Consent.
Exclusion criteria
1. Patient is pregnant or nursing. 2. Patient is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta. 3\. Patient has connective disease. 4. Patient is hypercoagulable. 5. Patient has active systemic infection. 6. Patient is less than 18 years old. 7. Patient has less than a one-year life expectancy. 8. Patient is unwilling or unable to return for follow-up visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aneurysm rupture | — |
| Stent graft occlusion | — |
| Collateral vessel occlusion | — |
| Delivery success | — |
| Deployment success | — |
| Stent graft migration | — |
| Aneurysm exclusion | — |
| Stent graft patency | — |
| Device integrity | — |
| Major morbidity and mortality | — |
| Vessel perforation | — |
Secondary
| Measure | Time frame |
|---|---|
| Patency | — |
| Technical success | — |
Countries
United States
Outcome results
None listed