Abdominal Aortic Aneurysm (AAA)NCT06586021
Evaluation of the Aortoseal™ for Sealing and Fixation of AAA Endovascular Grafts to Aortic Wall
A study testing Aortoseal Endostapling System in people with Abdominal Aortic Aneurysm (AAA), run by Endoron Medical at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm (AAA)
- What is being tested?
- Aortoseal Endostapling System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2024to 1 Nov 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Subjects diagnosed with a qualifying AAA suitable for elective endovascular repair with Endovascular Graft System or have a previously placed endovascular graft.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sentara Health Research Center
Norfolk, Virginia, 23507
Study Coordinator, 757-388-2407, AGANDERS@sentara.com
Principal Investigator
About this study
Official title: SEAL - Safety & Feasibility Evaluation of the Aortoseal™ for Seal and Fixation of Abdominal Aortic Aneurysms (AAA) Endovascular Grafts to the Aortic Wall"
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.
Read the 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.
- Conditions
- Abdominal Aortic Aneurysm (AAA)
- Being tested
- Aortoseal Endostapling System
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortoseal Endostapling SystemDevice
Aortoseal Endostapling System
| Study group | Role | What they receive |
|---|---|---|
| Aortoseal Endostapling System | Experimental | Prospective, early feasibility, non-randomized, single arm, multi-center, open-label clinical study Receives: Device: Aortoseal Endostapling System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start6 Feb 2024
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic Aneurysm (AAA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endoron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586021
- Sponsor's protocol ID
- 305CLD
- Status last verified
- Mar 2025
- First submitted
- 2 Sep 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No