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Endovascular Repair of Descending Thoracic Aortic Aneurysms
Trial ID: NCT00802984
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.
Endovascular Treatment of Thoracic Aortic Aneurysms Using the TALENT Stent Graft System
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
- 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
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
1. The stent graft would have to be positioned such that there would be no flow to an
artery, major branch artery or major branch arteries which supply the spinal cord.
2. The patient has congenital abnormalities in which the placement of the stent graft
will cause occlusion of major arterial flow. Such abnormalities should be evaluated
prior to treatment.
3. Patient is pregnant.
4. Patient is morbidly obese or has other clinical conditions that severely inhibit X-ray
visualization of the aorta.
5. Patient has connective tissue disease.
6. Patient has a hypercoagulability disorder.
7. Patient is in acute renal failure.
8. Patient has active systemic infection.
9. Patient is less than 18 years old.
10. Patient has less than a one-year life expectancy.
11. Patient is participating in another research study involving an investigational agent
for the treatment of Descending Thoracic Aortic Aneurysms.
12. Patient has other medical, social or psychological issues that in the opinion of the
investigator preclude them from receiving this treatment, and the procedures and
evaluations pre- and post-treatment.
13. Patient is unwilling or unable to return for or comply with follow-up visit schedules.
device: Endovascular thoracic aortic aneurysm repair using TALENT TAA Stent Graft System
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