---
title: Evaluation of the Aortoseal™ for Sealing and Fixation of AAA Endovascular Grafts to Aortic Wall
nct_id: NCT06586021
overall_status: RECRUITING
phase: NA
sponsor: Endoron Medical
study_type: INTERVENTIONAL
primary_condition: Abdominal Aortic Aneurysm (AAA)
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06586021.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06586021"
ct_last_update_post_date: 2025-03-12
last_seen_at: "2026-05-12T06:39:14.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Evaluation of the Aortoseal™ for Sealing and Fixation of AAA Endovascular Grafts to Aortic Wall

**Official Title:** SEAL - Safety & Feasibility Evaluation of the Aortoseal™ for Seal and Fixation of Abdominal Aortic Aneurysms (AAA) Endovascular Grafts to the Aortic Wall"

**NCT ID:** [NCT06586021](https://clinicaltrials.gov/study/NCT06586021)

## Key Facts

- **Status:** RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 25
- **Lead Sponsor:** Endoron Medical
- **Conditions:** Abdominal Aortic Aneurysm (AAA)
- **Start Date:** 2024-02-06
- **Completion Date:** 2029-11-01
- **CT.gov Last Update:** 2025-03-12

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Subjects diagnosed with a qualifying AAA suitable for elective endovascular repair with Endovascular Graft System or have a previously placed endovascular graft.
```

## Arms

- **Aortoseal Endostapling System** (EXPERIMENTAL) — Prospective, early feasibility, non-randomized, single arm, multi-center, open-label clinical study

## Interventions

- **Aortoseal Endostapling System** (DEVICE) — Aortoseal Endostapling System

## Primary Outcomes

- **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

## Locations (1)

- Sentara Health Research Center, Norfolk, Virginia, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.sentara health research center|norfolk|virginia|united states` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06586021.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06586021*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*