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The primary objective of the study is to evaluate the acute safety of deploying and implanting the Altura Endograft in the treatment of AAA in subjects who are candidates for endovascular repair.
Secondary objectives are to evaluate the acute and longer-term safety and performance of the Altura Endograft through 5 years.
The primary safety endpoint of the study is freedom from Major Adverse Events (MAE), a composite endpoint consisting of death, stroke, paraplegia, myocardial infarction, respiratory failure, renal failure, bowel ischemia and blood loss ≥ 1000 mL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AAA | Subjects with a documented untreated, unruptured, infrarenal abdominal aorto-iliac aneurysm will be treated with the Altura Endograft System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Altura Endograft System | Device | Subjects with a documented untreated, unruptured, infrarenal abdominal aorto-iliac aneurysm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint | Freedom from Major Adverse Events (MAE), a composite endpoint consisting of:
| 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Safety Endpoint |
| 30 days, 6 and 12 months and annually through 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Performance Endpoint |
|
Inclusion Criteria:
Exclusion Criteria:
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Subjects diagnosed with infrarenal abdominal aortic aneurysm (AAA) disease with suitable aneurysm morphology for endovascular repair.
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| Name | Affiliation | Role |
|---|---|---|
| Dierk Scheinert, MD, PhD | Park-Krenkenhaus Leipzig | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniklink | Freiburg im Breisgau | Germany | ||||
| University Heart Center |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Procedurally, 30 days, 6 and 12 months and annually through 5 years |
| Hamburg-Eppendorf |
| Germany |
| Park-Krankenhaus Leipzig | Leipzig | Germany |
| Sankt Bonifatius Hospital | Lingen | Germany |
| D001018 |
| Aortic Diseases |