Evaluation of the Aortoseal™ for Sealing and Fixation of AAA Endovascular Grafts to Aortic Wall
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aortoseal Endostapling System.
- Who it may be relevant to
- Registry conditions: Abdominal Aortic Aneurysm (AAA). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
SEAL - Safety & Feasibility Evaluation of the Aortoseal™ for Seal and Fixation of Abdominal Aortic Aneurysms (AAA) Endovascular Grafts to the Aortic Wall"
Overview
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
- Device Aortoseal Endostapling System
Aortoseal Endostapling System
Primary outcome measures
- Rate of Major Adverse Events [Time frame: through 5 years]
- Access Site Complications [Time frame: through 30 days]
- All Adverse Events [Time frame: through 5 years]
- Endpoints related to Aortoseal Endostapling System [Time frame: through 5 years]
- Device Technical Success [Time frame: during procedure]
Eligibility criteria
Subjects diagnosed with a qualifying AAA suitable for elective endovascular repair with Endovascular Graft System or have a previously placed endovascular graft.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Sentara Health Research Center — Norfolk
Identifiers
NCT: NCT06586021 · 305CLD