Further Evaluation of Safety and Performance of the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS DUO™ Aortic Arch Stent Graft System

Recruiting

• Conditions: AAT9

• Registration Number: NCT05636527
• Lead Sponsor: Endospan Ltd.

Brief Summary

The goal of this observational study is to collect clinical information on how safe, and how well the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS DUO™ Aortic Arch Stent Graft System work for the treatment of aortic aneurysms, in the standard-of-care setting.

The main question\[s\] it aims to answer are:

* Early mortality

* Safety outcomes throughout the study

* Device failure throughout the study

* Procedural and hospitalisation information Participants will be treated per institutional standard of care Follow-up information will be collected through to five years.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-09
• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-11-23
• Study First Posted: 2022-12-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-29
• Primary Completion: 2025-07
• Study Completion: 2030-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	30 days	The primary outcome in this study is early mortality, defined as lesion related death or any death that occurs within 30-days post-procedure or within initial hospitalization following the index procedure (whichever occurs last), unless there is evidence of accidental or self-inflicted death

Secondary Outcome Measures

Name	Time	Method
Device failure	Procedure, 30 days, 12 months	Device Failure will be assessed via the following outcomes: * Peri-operative device failure; * Device occlusion; * Surgical conversion; * Re-Intervention to treat migration,; * Re-Intervention to treat stenosis or occlusion,; * Re-Intervention to treat type Ia, Ib, III, IV endoleaks; * Re-Intervention for loss of device integrity
Major Adverse Event (MAE)	30 days and 12 months	Occurrence of at least one of the following MAEs at 30 days and 1 year post NEXUS implantation; * Disabling Stroke; * Permanent Paralysis/Paraplegia; * Renal failure; * Aortic rupture; * Development of new dissections in the thoracic aorta or brachiocephalic artery
Mortality	12 months	All-cause death events will be counted

Trial Locations

Locations (11)

University Hospital Duesseldorf; 🇩🇪 Duesseldorf, North-Rhine-Westphalia, Germany

APHP Henri Mondor; 🇫🇷 Paris, France

German Heart Center; 🇩🇪 Berlin, Germany

University Hospital Bonn; 🇩🇪 Bonn, Germany

University Hospital Padoua; 🇮🇹 Padova, Italy

Hospital Universitario Puerta del Mar; 🇪🇸 Cadiz, Andalucia, Spain

Hospital Alvaro Cunqueiro Vigo; 🇪🇸 Vigo, Galicia, Spain

Medical University of Warsaw; 🇵🇱 Warsaw, Poland

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

Klinikum Hirslanden, Aorten -und Gefäßzentrum, Zuerich; 🇨🇭 Zürich, Switzerland

Evaggelismos General Hospital; 🇬🇷 Athens, Greece