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The Aortoseal Endostapling System is indicated in patients undergoing, or having undergone, treatment of an abdominal aortic aneurysm (AAA) with an endovascular graft to provide enhanced fixation and apposition to the aorta.
The device may be implanted at the time of the initial endovascular graft procedure to maintain, or during a secondary procedure to restore, adequate aneurysm.
The study includes 5 years of follow-up, with visits at 30 days, 6 months, 1 year, and yearly thereafter through 5-years.
Follow-up assessments: Physical examination, X-ray, CT (with and without contrast) and assessments of any adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aortoseal Endostapling System | Experimental | Prospective, early feasibility, non-randomized, single arm, multi-center, open-label clinical study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aortoseal Endostapling System | Device | Aortoseal Endostapling System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Major Adverse Events | The EFS does not have defined primary endpoints nor any powered endpoints. The SEAL Study is not hypothesis driven. All endpoints will be analyzed descriptively | through 5 years |
| Access Site Complications | The EFS does not have defined primary endpoints nor any powered endpoints. The SEAL Study is not hypothesis driven. All endpoints will be analyzed descriptively | through 30 days |
| All Adverse Events | The EFS does not have defined primary endpoints nor any powered endpoints. The SEAL Study is not hypothesis driven. All endpoints will be analyzed descriptively | through 5 years |
| Endpoints related to Aortoseal Endostapling System | The EFS does not have defined primary endpoints nor any powered endpoints. The SEAL Study is not hypothesis driven. All endpoints will be analyzed descriptively | through 5 years |
| Device Technical Success | The EFS does not have defined primary endpoints nor any powered endpoints. The SEAL Study is not hypothesis driven. All endpoints will be analyzed descriptively | during procedure |
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Subjects diagnosed with a qualifying AAA suitable for elective endovascular repair with Endovascular Graft System or have a previously placed endovascular graft.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sentara Health Research Center | Recruiting | Norfolk | Virginia | 23507 | 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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| D001018 |
| Aortic Diseases |