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| ID | Type | Description | Link |
|---|---|---|---|
| IRB Protocol Number 77836 |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular thoracic aortic aneurysm repair using TALENT TAA Stent Graft System | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Stent graft migration | ||
| Vessel Dissection or perforation | ||
| Stent graft occlusion | ||
| Collateral vessel occlusion | ||
| Aneurysm rupture | ||
| Aneurysm exclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | ||
| Patency |
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Inclusion Criteria:
Patient is a candidate for repair of a descending thoracic aortic aneurysm.
Patient has one or more of the following:
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.
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
Patient has a non-aneurysmal proximal and distal aortic neck diameter between 25 and 36 mm.
Patient is American Society of Anesthesiology (ASA) grade 1 through 4.
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.
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.
Patient or patient's legal representative understands and has signed an Informed Consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher K Zarins, MD | Stanford University | Principal Investigator |
| Jason T Lee, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| D001018 |
| Aortic Diseases |