CLINICAL 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
NEXUS Arch - A Multicenter Study Evaluating the Initial Experience
David MD; Elbaz-Greener, Gabby MD; Mangialardi, Nicola MD; Lindsay, Thomas MD; D’Onofrio, Augusto MD; Schelzig, Hubert MD; Chaykovska, Lyubov MD; Hill, Andrew MD; Holden, Andrew MD; Antonello, Michele MD; Tan, Kong T. MD; Orrico, Matteo MD; Ronchey, Sonia MD; Marmur, Yaniv BSc; Pecoraro, Felice MD; Lachat, Mario MD
"The NEXUS Aortic Arch Stent Graft System, a novel single branch, two stent graft system used for endovascular aortic arch repair that requires landing in the ascending aorta, demonstrates a high success rate with excellent one year safety and performance."
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."
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
Mangialardi, N. Journal of Vascular Surgery 2015
"We believe that this graft will play a large role in the treatment of arch pathologies."
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."
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"
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"
Lindsay, T. Linc Conference 2017.
Case Studies
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.
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.
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.
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.
Scientific Publication Summaries
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
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.