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| Name | Class |
|---|---|
| Auckland City Hospital | OTHER_GOV |
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The goal of this clinical trial is to evaluate the safety and feasibility of the Cygnum Aneurysm Sac Management Device in patients with abdominal aortic aneurysms treated with endovascular aneurysm repair (EVAR). The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cygnum ASMD Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cygnum Aneurysm Sac Management Device (ASMD) | Device | Cygnum ASMD, adjunctive to EVAR, lines the aneurysmal wall to prevent type II endoleaks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major adverse events (MAEs) | Rate of related major adverse events (MAEs) | 30 days post-procedure |
| Procedural Technical Success | Technical success, defined as lining the AAA sac wall with the investigational devices | Immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of related major adverse events (MAEs) | Incidence rate of related major adverse events (MAEs) | 12 months post procedure |
| Incidence of related serious adverse events (SAEs) | Incidence rate of related serious adverse events (SAEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raja N Ghanem | Contact | 612-840-2723 | contact@lifesealvascular.com |
| Name | Affiliation | Role |
|---|---|---|
| Raja Ghanem | Life Seal Vascular Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auckland City Hospital | Recruiting | Auckland | New Zealand |
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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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| 12 months post procedure |
| Efficacy - Type II endoleaks | Incidence of type II endoleaks | 12 months post procedure |
| Efficacy - AAA sac diameter | Change in AAA sac diameter | 12 months post procedure |
| D001018 |
| Aortic Diseases |