Actively Recruiting
NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness
Led by Endospan Ltd. · Updated on 2025-10-20
110
Participants Needed
32
Research Sites
466 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch Stent Graft System (NEXUSTM) 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.
CONDITIONS
Official Title
NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female age 63; 18.
- Proximal/ascending native or previously implanted surgical graft landing zone of appropriate length.
- Proximal/ascending native or previously implanted surgical graft landing zone of appropriate diameter.
- Distal/descending native landing zone of appropriate length.
- Distal/descending native landing zone of appropriate diameter.
- Brachiocephalic trunk native landing zone of appropriate length.
- Brachiocephalic trunk native landing zone of appropriate diameter.
- Appropriate take off angle between the Brachiocephalic Artery and the Aortic Arch perpendicular.
- Appropriate aortic arch perpendicular diameter.
- Chronic dissection with at least one of the following: aortic aneurysm 63; 55 mm, rapidly expanding false lumen, compressed true lumen with end organ malperfusion, or symptomatic.
- Aneurysm with at least one of the following: aortic arch dilatation >5 cm for fusiform aneurysm, dilatation 1.5 times normal for ascending or descending, dilatation >2.5 cm for saccular aneurysm, symptomatic, growth rate >5 mm per 6 months, or postoperative pseudoaneurysm.
- Penetrating aortic ulcer that is symptomatic or shows expansion.
- Intramural hematoma that is symptomatic or shows expansion on imaging.
- Proximal/ascending native or previously implanted surgical graft landing zone appropriate if lesion is in ascending aorta.
- Femoral/iliac artery diameter suitable for 20 Fr. delivery catheter access.
- Access vessel morphology suitable for endovascular repair.
- Brachial/axial artery diameter suitable for 7 Fr. access.
- Considered an appropriate candidate for elective surgery.
- Considered high risk for open repair by investigator.
- Access vessels compatible with vascular access techniques and devices.
- Willing and able to comply with study procedures and follow-up visits.
You will not qualify if you...
- Acute dissection.
- Lesions treatable with TEVAR landing in zone 2.
- Required emergent treatment such as trauma or rupture.
- Acute vascular injury of the aorta due to trauma.
- Aortic rupture or unstable aneurysm.
- Previous stent or stent graft in the treated or planned landing area.
- Required treatment of an infra-renal aneurysm at implantation time.
- Planned major surgical or interventional procedure at screening.
- Major surgery or intervention within 6 weeks before implantation, except necessary procedures for stent graft placement.
- Myocardial infarction or cerebral vascular accident within 90 days prior to implantation.
- Severe aortic valvular insufficiency.
- Mechanical valve preventing safe device delivery.
- Known connective tissue disease (e.g., Marfan's, Ehler's-Danlos).
- Active systemic infection at procedure time.
- Pregnancy.
- Life expectancy less than 2 years.
- Unsuitable vascular anatomy.
- Previously implanted surgical wrap of ascending aorta.
- Medical condition increasing risk with device or procedure.
- Mycotic, inflammatory, or suspected infected aneurysm.
- Hostile groins or axilla unless conduit used.
- Severe atherosclerosis, calcification, or thrombus in aorta or brachiocephalic trunk.
- Unstable angina or NYHA class III or IV.
- Hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media.
- Contraindication to angiography.
- Known allergies to device materials.
- Conditions severely inhibiting x-ray visualization of aorta.
- History of bleeding disorder limiting antiplatelet or anticoagulant therapy.
- Acute or chronic renal failure with creatinine >2.00 mg/dl.
- Other medical, social, or psychological issues precluding treatment or study procedures.
- Active participation in another interfering clinical study or planning to participate before this study ends.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 32 locations
1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
University of California San Diego Medical Center
La Jolla, California, United States, 92037
Actively Recruiting
3
UC Davis Health
Sacramento, California, United States, 95817
Completed
4
Stanford University School of Medicine
Stanford, California, United States, 94305
Actively Recruiting
5
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
6
Hartford Hospital
Hartford, Connecticut, United States, 06102
Actively Recruiting
7
MedStar Washington Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
8
Advent Health Orlando
Orlando, Florida, United States, 32804
Completed
9
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
10
The University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
11
Ascension St. Vincent
Carmel, Indiana, United States, 46290
Completed
12
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
13
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Completed
14
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
15
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
16
The Mount Sinai Medical Center
New York, New York, United States, 10029
Actively Recruiting
17
Northwell Health Lenox Hill Hospital
New York, New York, United States, 10075
Actively Recruiting
18
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
19
Atrium Health
Charlotte, North Carolina, United States, 28203
Actively Recruiting
20
Duke University Medical Center
Durham, North Carolina, United States, 27710
Completed
21
The Lindner Research Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
22
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Actively Recruiting
23
Oregon Health
Portland, Oregon, United States, 97239
Actively Recruiting
24
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
25
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
Completed
26
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
27
Ballad Health
Kingsport, Tennessee, United States, 37660
Completed
28
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
29
Baylor Scott and White
Plano, Texas, United States, 75093
Actively Recruiting
30
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Actively Recruiting
31
Carilion Clinic
Roanoke, Virginia, United States, 24014
Actively Recruiting
32
Auckland City Hospital
Auckland, Grafton, New Zealand, 1023
Actively Recruiting
Research Team
J
Jessica Kleine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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