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NEXUS™ Aortic Arch Stent Graft System First In Man Study | Clinical Trials | Clareo Health

COMPLETEDNA

NEXUS™ Aortic Arch Stent Graft System First In Man Study

Feasibility Clinical Study to Evaluate the Safety and Performance of the NEXUS™ Aortic Arch Stent Graft System

NCT02365454•Endospan Ltd.

Summary

A multicenter, prospective, open-label, non-randomized, interventional clinical study, sponsored by Endospan Ltd. Patients will be followed-up for five years.

Detailed Description

The purpose of the study is to evaluate the safety and performance of the Nexus™ Aortic Arch Stent Graft System for the endovascular treatment of thoracic aortic pathologies requiring landing in the Aortic Arch (zone 0, zone 1, zone 2). The Nexus™ Aortic Arch Stent Graft System is indicated for the endovascular treatment of thoracic aortic pathologies involving the aortic arch (such as aneurisms and dissections). The Nexus™ is intended to exclude the lesion from the blood circulation in patients diagnosed with thoracic aortic pathology and who have appropriate anatomy to accommodate the Nexus™ system in an endovascular procedure. The primary objectives of the study are to evaluate the safety and performance of the Nexus™ Aortic Arch Aneurysm Stent Graft System.

Eligibility

Age

18 - 95 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female age ≥ 18.
•Any Thoracic Aorta pathology requiring landing in the Aortic Arch (zone 0, zone 1, zone2), e.g. aneurysm, dissection, false/Pseudo aneurysm.
•In patient with a thoracic aneurysm: dilatation of the aortic arch larger than 5.5cm in diameter, or symptomatic aneurysm of the aortic arch, or aortic diameter growth rate \> 5mm per 6 months
•Patient is considered an appropriate candidate for an elective surgery, as evaluated by Physical Status Classification System I, II or III (American Society of Anesthesiologists).
•Femoral artery diameter as documented by CTA or MRA that allows endovascular access to the diseased site with a 20-22Fr delivery catheter.
•Access vessels morphology suitable for endovascular repair in terms of tortuosity, calcification and angulation, documented by CTA, MRA.
•Access vessel (femoral/iliac) diameter \> 7 mm
•Ascending Aorta landing zone length \> 30 mm
•Brachial/Axial Artery diameter \> 3 mm
•Patient understands and is voluntarily willing to participate as evidenced by personally signing the Informed Consent document, and willingness to comply with follow-up schedule

Exclusion Criteria

•Female is of childbearing potential
•Life expectancy of less than 1 year
•Any medical condition that, according to the investigator's decision, might expose the patient to increased risk by the investigational device or procedure.
•Acutely ruptured or instable aneurysm or an acute vascular injury due to trauma or infected penetrating ulcers of the aorta.
•Patient with an increased risk for aneurysm rupture during the procedure.
•Patient whose arterial access site is not anticipated to accommodate the access of the Nexus™ Delivery System, due to size, tortuosity or hostile groins (scarring, obesity, or previous failed puncture)
•Patients with severe atherosclerosis or intraluminal thrombus of the aorta or in the BCT
•Patient is suffering from unstable angina or NYHA classification III and IV and/or ASA classification IV and above.
•Patient has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 3 months prior to the planned implantation
•Patient has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.
+11 more criteria

Locations (4)

Faculty Hospital Hradec Kralove

Hradec Králové, Czechia

San Filippo Neri Hospital

Rome, Italy

Klinic Hirslanden

Zurich, Witellikerstrasse 40, Switzerland

Zurich University Hospital

Zurich, Switzerland

Key Dates

Start Date

August 1, 2014

Primary Completion Date

November 1, 2018

Completion Date

June 1, 2023

Last Updated

September 21, 2023

Enrollment

ACTUAL participants

Conditions

Thoracic Aortic Arch DiseaseThoracic Aortic Aneurysm

Interventions

Stent Graft Placement (Nexus)

DEVICE

Terumo Aortic Global Endovascular Registry

NCT04246463

Abdominal Aortic AneurysmThoracic Aortic Aneurysm+1 more

View study

RECRUITINGNA

Effects of Exercise on Thoracic Aneurysms

NCT04197648

Thoracic Aortic Aneurysm

View study

RECRUITING

Incidence of Major Complication in Case of Thoracic Aortic Aneurysm

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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NEXUS™ Aortic Arch Stent Graft System First In Man Study

Inclusion Criteria

Exclusion Criteria

Terumo Aortic Global Endovascular Registry

Effects of Exercise on Thoracic Aneurysms

Incidence of Major Complication in Case of Thoracic Aortic Aneurysm

Endovascular Treatment of Thoracic Aortic Disease

POCUS Screening for TAA in Hypertensive Patients in the ED

VALOR: The Talent Thoracic Stent Graft System Clinical Study