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CLINICAL STUDY
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TRIOMPHE US IDE STUDY

Prospective, non-randomized, multi-center clinical investigation of the NEXUS® Aortic Arch Stent Graft System (NEXUS®) for the treatment of thoracic aortic lesions involving the aortic arch with a proximal landing zone, native or previously implanted surgical graft, in the ascending aorta and with a brachiocephalic trunk native landing zone

Publications
First Experience With the New NEXUS Stent Graft for the Arch

NEXUS Arch: A Multicenter Study Evaluating the Initial
Experience With a Novel Aortic Arch Stent Graft System

David Planer, MD, Gabby Elbaz-Greener, MD, Nicola Mangialardi, MD, Thomas Lindsay, MD, Augusto D’Onofrio, MD, Hubert Schelzig, MD, Lyubov Chaykovska, MD, Andrew Hill, MD, Andrew Holden, MD, Michele Antonello, MD, Kong T. Tan, MD, Matteo Orrico, MD, Sonia Ronchey, MD, Yaniv Marmur, BSc, Felice Pecoraro, MD, and Mario Lachat, MD

To assess the initial clinical experience with a novel endograft system (NEXUS Aortic Arch Stent Graft System) designed to treat aortic arch pathologies and address the morphology and hemodynamic challenges of the aortic arch.

First Experience With the New NEXUS Stent Graft for the Arch

Total aortic arch repair between endo and hybrid – The Nexus single-branched endograft

Mario Lescan, M.D. Department of Thoracic and Cardiovascular Surgery University Medical Center Tübingen Hoppe-Seyler Strasse 3 D-72076 Tübingen, Germany

Minimal invasive zone 0 arch procedures have experienced a great evolution from the total zone 0 debranching techniques toward the total endovascular aortic arch procedures in the last decade.

First Experience With the New NEXUS Stent Graft for the Arch

Three-year Follow Up Of Aortic Arch Endovascular Stent-Grafting with the Nexus 3 device

Augusto D’Onofrio, MD, Mario Lachat, MD, Nicola Mangialardi, MD, Michele Antonello, MD, Hubert Schelzig, MD, Lyubov Chaykovska, MD, Andrew Hill, MBChB, Andrew Holden, MBChB, Thomas Lindsay, MD, Kong Ten Tan, MD, Matteo Orrico, MD, Sonia Ronchey, MD Gabby Elbaz Greener, MD, Paul Hayes, MD, Giulia Lorenzoni, PhD, Gino Gerosa, MD and David Planer, MD

The Nexus stent graft system provides promising clinical and radiographic outcomes up to 3-year in high-risk patients.

First Experience With the New NEXUS Stent Graft for the Arch

Feasibility Of Total Endovascular Aortic Arch Exclusion After Surgery For Type A Acute Aortic Dissection: Why Aren’T All Patients Eligible?

Augusto D’Onofrio Giorgia Cibin, Elisa Gastino, Irene Cao, Michele Antonello, Gino Gerosa. University of Padova, Padova, Italy.

Total endovascular aortic arch exclusion (TEX) has shown to be a safe and effective option in high-risk patients requiring treatment for arch pathologies, especially after surgery for type A acute aortic dissection (TAAD).

First Experience With the New NEXUS Stent Graft for the Arch

Anatomical feasibility of the total endovascular aortic arch repair and what lies beyond

Mario Lescan, M.D. Department of Thoracic and Cardiovascular Surgery University Medical Center Tübingen Hoppe-Seyler Strasse 3 D-72076 Tübingen, Germany

The frozen elephant trunk (FET) is regarded as the gold standard for the treatment of aortic arch pathologies [1]. In the last years, the treatment standardization including novel perfusion and operation strategies, new monitoring, and perioperative care techniques and the evolution of the next-generation hybrid prostheses led to a considerable reduction in mortality for acute and elective operations.

First Experience With the New NEXUS Stent Graft for the Arch

Endovascular repair of the aortic arch with the NEXUS Stent Graft System

Enrique M. San Norberto, Noelia Cenizo, Cintia M. Flota, and Carlos Vaquero

Surgery of aortic arch diseases like aneurysms and dissections require invasive procedures that include cardiopulmonary bypass, selective cerebral perfusion, aortic cross-clamping, and hypothermic circulatory arrest

First Experience With the New NEXUS Stent Graft for the Arch

Aortic Arch Solutions

D'Onofrio, A. Vascular News 2020

"Augusto D’Onofrio, Giorgia Cibin, and Michele Antonello outline the features and benefits of the JOTEC E-vita OPEN NEO and the NEXUS Aortic Arch Stent Graft System for the treatment of aortic arch pathologies."

First Experience With the New NEXUS Stent Graft for the Arch

Endovascular exclusion of the entire aortic arch with branched stent-grafts after surgery for acute type A aortic dissection

Augusto D’Onofrio, MD, PhD, Giorgia Cibin, MD, Michele Antonello, MD, Piero Battocchio, MD, Michele Piazza, MD, Raphael Caraffa, MD, Alberto Dall’Antonia, MD, Franco Grego, MD, and Gino Gerosa, MD

The treatment of residual pathology of the aortic arch after surgical repair for type A acute dissection (AAD) represents a therapeutic challenge.

First Experience With the New NEXUS Stent Graft for the Arch

Endovascular exclusion of the entire aortic arch with branched stent-grafts after surgery for acute type A aortic dissection

D’Onofrio et all – JTCVS Techniques 2020

This preliminary experience shows that ASG after surgery for AAD is feasible and provides encouraging clinical and anatomic early results.

First Experience With the New NEXUS Stent Graft for the Arch

Endovascular exclusion of the entire aortic arch with
branched stent-grafts after surgery for acute type A
aortic dissection

Augusto D’Onofrio, MD, PhD, Giorgia Cibin, MD, Michele Antonello, MD, Piero Battocchio, MD, Michele Piazza, MD, Raphael Caraffa, MD, Alberto Dall’Antonia, MD, Franco Grego, MD, and Gino Gerosa, MD

The treatment of residual pathology of the aortic arch after surgical repair for type A acute dissection (AAD) represents a therapeutic challenge.

First Experience With the New NEXUS Stent Graft for the Arch

Bailout Implantation of a New Single-Branch Stent Graft for the Aortic Arch

Giorgia Cibin, MD, Augusto D’Onofrio, MD, Michele Antonello, MD, Cosimo Guglielmi, MD, Franco Grego, MD, and Gino Gerosa, MD

In this paper we describe a case of a rapidly growing pseudoaneurysm of the aortic arch occurring after surgery for acute type A aortic dissection that was successfully treated with an off-the-shelf, single-branch, dual-module aortic arch endovascular stent graft.

First Experience With the New NEXUS Stent Graft for the Arch

Early Results of Arch Disease Treated with Nexus Arch Endograft

Thomas Lindsay, Maral Ouzounian, Kong Tan. Divisions of Vascular Surgery, Cardiovascular Surgery, and Interventional Radiology, University Health Network, and the Division of Vascular Surgery, University of Toronto, Toronto, Ontario

The objective of this study was to describe the results of five consecutive cases of aortic arch disease repaired using the novel Nexus arch endograft (Endospan, Herzliya, Israel).

First Experience With the New NEXUS Stent Graft for the Arch

Early Results of Arch Disease Treated with NEXUS Arch Endograft

Lindsay, T. Journal of Vascular Surgery 2017

"Our early experience with the NEXUS arch graft has been successful in treating challenging arch aneurysmal disease without stroke or mortality in a high-risk population."

First Experience With the New NEXUS Stent Graft for the Arch

Endovascular treatment of Aortic Arch Aneurism With A Single-Branched Double-Stage Stent Graft

Augusto D’Onofrio, MD, PhD, Michele Antonello, MD, PhD, Mario Lachat, MD, David Planer, MD, Andrea Manfrin, BSc, Andrea Bagno, BSc, David Pakeliani, MD, Franco Grego, MD, and Gino Gerosa, MD, Padova, Italy; Zurich, Switzerland; and Jerusalem, Israel

"Endovascular stent grafting of the aortic arch is a new promising emerging technology that allows the exclusion of aortic arch aneurisms through a micro-invasive procedure."

First Experience With the New NEXUS Stent Graft for the Arch

Endovascular treatment of aortic arch aneurysm with a single-branched double-stage stent graft

Augusto D’Onofrio, MD, PhD, Michele Antonello, MD, PhD, Mario Lachat, MD, David Planer, MD, Andrea Manfrin, BSc, Andrea Bagno, BSc, David Pakeliani, MD, Franco Grego, MD, and Gino Gerosa, MD, Padova, Italy; Zurich, Switzerland; and Jerusalem, Israel

Endovascular stent grafting of the aortic arch is a new promising emerging technology that allows the exclusion of aortic arch aneurysms through a micro-invasive procedure.

First Experience With the New NEXUS Stent Graft for the Arch

First Experience With the New NEXUS Stent Graft for the Arch

Mangialardi, N. Journal of Vascular Surgery 2015

"We believe that this graft will play a large role in the treatment of arch pathologies."

First Experience With the New NEXUS Stent Graft for the Arch

First Experience With the New Nexus Stent Graft

This study presents our first experience with the Nexus stent graft (SG) by Endospan currently under investigation, which is indicated for aneurysms and dissections of the arch.

presentations

"Effective minimally invasive option for aortic pathology involving the aortic arch • Approved Off-the-Shelf Solution (Feb. 2019) • Promising mid term results • Low procedural time results in procedural predictability"

Update on the NEXUS Off-The-Shelf Single Branch Device

Lachat, M. Veith Symposium 2019.

"Novel modular design with minimal arch manipulation • Arch debranching is still a major procedure • Favorable early results with no mortality, spinal cord ischemia or strokes • Applicable to arch aneurysms and type A dissections with ascending aortic grafts in place that require arch and descending aortic coverage"

Early Canadian Experience with the NEXUS Arch Graft

Lindsay, T. Linc Conference 2017.

Case Studies
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HIGH-RISK PATIENT WITH PROGRESSIVE DISSECTION RECEIVES SUCCESSFUL TREATMENT IN TRIOMPHE STUDY

University of Alabama at Birmingham
Birmingham, Alabama

One month follow-up CT shows a stable position of NEXUS and no endoleak identified.

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HIGH-RISK PATIENT WITH GROWING SACCULAR ANEURYSM RECEIVES SUCCESSFUL TREATMENT IN TRIOMPHE STUDY

University of Michigan Health
Ann Arbor, Michigan

A one-month follow-up CT showed a stable position of NEXUS and no endoleak identified.

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PATIENT WITH PREVIOUS OPEN ARCH REPAIR RECEIVES MINIMALLY-INVASIVE DISSECTION REPAIR

Sentara Heart Hospital
Norfolk, VA

Six-month follow-up CT showed a stable position of NEXUS and no endoleak identified.

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DURABILITY OF ENDOVASCULAR REPAIR OF THE AORTIC ARCH WITH THE NEXUS AORTIC ARCH STENT GRAFT SYSTEM

San Camillo Hospital & Filippo Neri Hospital
Rome, Italy

The patient was discharged and followed up with the hospital’s standard of care. The 39-month follow-up computed tomography angiography illustrated the stable exclusion of the false lumen.

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NEXUS AORTIC ARCH STENT GRAFT SYSTEM AND THE STABILISE TECHNIQUE TO SUCCESSFULLY TREAT A RESIDUAL TYPE A DISSECTION WITH ANEURYSMAL DEGENERATION

Hôpital Européen Georges-Pompidou
Paris, France

Post-operative course was uneventful, and the patient could be discharged at day 4 after 2 days of CSF drainage surveillance in the ICU. Pre-discharge control computed tomography confirmed optimal positioning of NEXUS in relation to a kink in the proximal ascending aorta surgical prosthesis, exclusion of proximal entry tear and a satisfying result of the STABILISE technique.

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MULTIDISCIPLINARY STAGED ENDOVASCULAR REPAIR OF THE AORTIC ARCH WITH NEXUS™

Interventional Radiology & Cardiovascular Department,
Aretaeio Hospital
Nicosia, Cyprus

The patient was discharged 1 day after the endovascular procedure. The discharge computed tomography angiography confirmed the absence of endoleaks proximally with an expected retrograde endoleak Type 1B which will be resolved at Stage 3.

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DURABILITY OF A CHALLENGING ENDOVASCULAR REPAIR OF THE AORTIC ARCH

Hirslanden Klinik
Zurich, Switzerland

The 21-month follow-up computed tomography angiography illustrated the integrity and stable position of NEXUS as well as complete exclusion of the aneurysm.

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FIRST EXPERIENCE WITH SENTINEL IN HIGH STROKE RISK PATIENT WITH AORTIC ARCH ANEURYSM

Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Spain

Postoperative cerebral imaging didn’t reveal any sign of stroke, hemorrhage or respective micro bleeds, but slight signs of amyloidosis. Some days later, the patient was discharged home.

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CHRONIC DISSECTION PATIENT RECEIVES GROUNDBREAKING MINIMALLY INVASIVE TREATMENT IN TRIOMPHE CLINICAL STUDY

The Christ Hospital
Cardiothoracic Surgery Division
Cincinnati, Ohio

Six month follow-up CT shows a stable position of NEXUS and no endoleak identified.

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Symptomatic Aortic Arch Contained Rupture

Royal Brompton Hospital
London, UK

Due to the minimally invasive nature of the procedure, the patient was able to leave her bed very quickly and was discharged within a few days, with her recovery time reduced from several weeks.

Scientific Publication Summaries

Enrique M. San Norberto*, Noelia Cenizo, Cintia M. Flota & Carlos Vaquero. Rec Interv. Cardiol. 2020

Endovascular repair of the aortic arch with the NEXUS™ Stent Graft System

Endovascular repair of the aortic arch with the NEXUS™ Stent Graft System

A 75-year-old male patient underwent emergency surgery for acute type A aortic dissection repair.

Cibin et al. Ann Thorac Surg 2020

BAILOUT IMPLANTATION OF A NEW SINGLE-BRANCHED STENT GRAFT FOR THE AORTIC ARCH

BAILOUT IMPLANTATION OF A NEW SINGLE-BRANCHED STENT GRAFT FOR THE AORTIC ARCH

74-year-old male, COPD, previous MI, right nephrectomy (Ca), Diabetes Mellitus, Dyslipidemia, Button Bentall + Hemi Arch for Acute Type A Dissection.

Cibin et al. Ann Thorac Surg 2020

Bailout Implantation of a New Single-Branch Stent Graft for the Aortic Arch - The Annals of Thoracic Surgery

Bailout Implantation of a New Single-Branch Stent Graft for the Aortic Arch - The Annals of Thoracic Surgery

This case shows that urgent endovascular treatment of the aortic arch with an off-the-shelf single-branch bimodular aortic arch stent graft is feasible and can be performed with good early outcomes.

CAUTION: Investigational Device – Limited by United States law to investigational use. Endospan devices bear the CE marking of conformity.
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