Endovascular Treatment of Thoracic Aortic Aneurysms Using the TALENT Stent Graft System
The purpose of this study is to determine whether the system is safe and effective for the intended use of treating descending thoracic aortic aneurysms.
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 thoracic aortic aneurysm repair using TALENT TAA Stent Graft System
Phase: Phase 4
Ages Eligible For Study:
1. Patient is a candidate for repair of a descending thoracic aortic aneurysm. 2. Patient has one or more of the following: - Descending thoracic aneurysm, 5 cm in diameter or greater with proximal and distal neck suitable for stent graft placement. - Aneurysm is 4-5 cm in diameter but has increased in size by 0.5 cm in last 6 months. - Maximum diameter of aneurysm exceeds one and one-half times the transverse dimension of an adjacent normal aortic segment. - Post-traumatic pseudoaneurysm - Post-surgical pseudoaneurysm - Saccular aneurysm - Contained rupture - Penetrating ulcer 3. Patient's vascular dimensions must be in the range that can be safely treated with the stent graft and extensions available to the physician at the time of the procedure. 4. Patient has patent iliac or femoral arteries or acceptable retroperitoneal access via the abdominal aorta that allow endovascular access to the aneurysmal site with a 23F delivery catheter, typically used with a 25F introducer sheath 5. Patient has a non-aneurysmal proximal and distal aortic neck diameter between 25 and 36 mm. 6. Patient is American Society of Anesthesiology (ASA) grade 1 through 4. 7. Patient has a stage of disease or condition where there is no comparable or satisfactory alternative device or therapy available for treatment; or the patient has an immediately life-threatening disease 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. 8. Patient is able and willing to comply with 1 month, 6 month, and 1 year follow-up, and willing to comply with annual post-treatment follow-up requirements thereafter. 9. Patient or patient's legal representative understands and has signed an Informed Consent.