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NCT06586021 · ClinicalTrials.gov registry record · NA

Evaluation of the Aortoseal™ for Sealing and Fixation of AAA Endovascular Grafts to Aortic Wall

A NA study of Abdominal Aortic Aneurysm (AAA), sponsored by Endoron Medical.

Recruiting
Registry status
NA
Development phase
25
Enrollment target
1
Study location

NCT06586021: Recruiting NA study of Abdominal Aortic Aneurysm (AAA), sponsored by Endoron Medical.

NCT06586021 is a NA study of Abdominal Aortic Aneurysm (AAA) that is actively recruiting participants, run by Endoron Medical. The registered enrollment target is 25 participants, below the 180-participant average among 3 other Abdominal Aortic Aneurysm (AAA) trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06586021, a NA study of Abdominal Aortic Aneurysm (AAA), is actively recruiting participants, sponsored by Endoron Medical.

RECRUITING
Registry status
NA
Development phase
25 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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

Interventions

  • DEVICE Aortoseal Endostapling System

Study Locations (1)

Virginia

  • Sentara Health Research Center - Norfolk

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2024-02-06
Est. Completion 2029-11-01
Phase NA
Endoron Medical

1 total trials

What NCT06586021 shows while recruiting

NCT06586021 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 180-participant average among 3 other Abdominal Aortic Aneurysm (AAA) trials with a reported enrollment target (86% lower).

The record links to 1 condition, with Abdominal Aortic Aneurysm (AAA) appearing as the primary indexed condition, and to 1 intervention - of which Aortoseal Endostapling System is the first listed.

NCT06586021 reports a single indexed study location in Virginia.

Frequently Asked Questions

What is clinical trial NCT06586021 about?

NCT06586021 is a clinical study titled "Evaluation of the Aortoseal™ for Sealing and Fixation of AAA Endovascular Grafts to 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.

What is the current status of trial NCT06586021?

This trial is currently recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2024-02-06. Estimated completion is 2029-11-01.

What conditions does trial NCT06586021 study?

This clinical trial studies the following conditions: Abdominal Aortic Aneurysm (AAA).

What interventions are being tested in trial NCT06586021?

The interventions under investigation include: Aortoseal Endostapling System (DEVICE).

Who is sponsoring clinical trial NCT06586021?

This trial is sponsored by Endoron Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06586021 being conducted?

This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT06586021, the US trial registry maintained by the National Library of Medicine. NCT06586021 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.