TALENT Endoluminal Stent Graft System for the Treatment of Abdominal Aortic Aneurysms
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.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- device : Endovascular Repair of Abdominal Aortic Aneurysms Using TALENT AAA Stent Graft System
Phase: Phase 4
Ages Eligible For Study:
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.