Abdominal Aortic Aneurysm (AAA)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAortoseal Endostapling System
Aortoseal Endostapling System
Sponsors
Endoron Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects diagnosed with a qualifying AAA suitable for elective endovascular repair with Endovascular Graft System or have a previously placed endovascular graft.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Major Adverse Events | through 5 years | 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 |
| Access Site Complications | through 30 days | 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 |
| All Adverse Events | through 5 years | 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 |
| Endpoints related to Aortoseal Endostapling System | through 5 years | 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 |
| Device Technical Success | during procedure | 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 |
Countries
United States
Outcome results
None listed