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The objective of this clinical study is to assess the safety and effectiveness of the Cordis Endovascular Quantum LPâ„¢ Stent Graft System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | QUANTUM LPâ„¢ STENT GRAFT SYSTEM |
|
| 2 | Active Comparator | Surgical intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QUANTUM LPâ„¢ STENT GRAFT SYSTEM | Device | Stent Graft System for the Treatment of Abdominal Aortic Aneurysms |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the aneurysm-related one-year mortality rates of the stent graft patients to open surgery patients. The purpose of having an aneurysm surgically or endovascularly repaired is to prevent death from AAA. | One year | |
| To compare the one-year procedure-related severe adverse event rates of the stent graft patients to open surgery patients. These events exclude aneurysm-related deaths. The endpoint for this objective will be the occurrence of any serious adverse eve | One year |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the occurrence of severe device-related adverse events as they relate to the cause of aneurysm exclusion failures (i.e., Type I and III endoleaks, significant AAA growth, or AAA rupture). | 30 days, 6 mo, and annually up to five years | |
| To compare the rate and amount of blood products used in the stent graft procedure to open surgery. |
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Inclusion Criteria (Surgical Patients):
Inclusion Criteria (Stent Graft Patients)
Exclusion Criteria (Surgical and Stent Graft Patients):
Exclusion Criteria (Stent Graft Patients only)
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| Name | Affiliation | Role |
|---|---|---|
| H. Wayne Hutman, MD | Cordis US Corp. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
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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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| Open surgical repair | Procedure | Open surgical repair |
|
| At procedure |
| D001018 |
| Aortic Diseases |