NCT06586021 · Endoron Medical
Evaluation of the Aortoseal™ for Sealing and Fixation of AAA Endovascular Grafts to Aortic Wall
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Aortoseal Endostapling System
Aortoseal Endostapling System
Primary outcome measures
Rate of Major Adverse Events
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subjects diagnosed with a qualifying AAA suitable for elective endovascular repair with Endovascular Graft System or have a previously placed endovascular graft.
Where
- Norfolk, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 12, 2025 · Source of record for eligibility and locations