Actively Recruiting
A Multi-Center Clinical Study to Evaluate Safety and Effectiveness of the NEXUS Aortic Arch Stent Graft System for Treating Thoracic Aortic Lesions Involving the Aortic Arch
Led by Endospan Ltd. · Updated on 2025-10-20
110
Participants Needed
32
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the NEXUS Aortic Arch Stent Graft System in adults with thoracic aortic lesions involving the aortic arch and ascending aorta. This prospective, non-randomized, multi-center clinical investigation aims to assess the safety and effectiveness of this device for treating conditions such as aortic dissection, aneurysm, intramural hematoma, and penetrating aortic ulcer. The study focuses on patients with specific anatomical landing zones in the aortic arch and brachiocephalic trunk. The study uses the NEXUS Aortic Stent Graft System, which includes an arch stent graft deployed into the brachiocephalic artery and descending thoracic aorta, and an ascending stent graft for the ascending aorta. An optional descending extension can cover longer lesions if needed. Participants receive the device through endovascular repair with access via femoral, iliac, or brachial/axillary arteries. The study includes multiple arms targeting different lesion types, some closed to enrollment. Participants will undergo device implantation and follow-up visits to monitor technical and clinical outcomes at 30 days, including device technical failure and clinical failure. Assessments include imaging to evaluate vascular access and lesion coverage, along with safety monitoring. Participants must comply with study procedures and return for follow-up as scheduled. The study does not specify a maximum age and excludes certain acute or emergent conditions and prior treatments in the target area.
CONDITIONS
Brief Title
NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Proximal/ascending native or previously implanted surgical graft landing zone of appropriate length and diameter
- Distal/descending native landing zone of appropriate length and diameter
- Brachiocephalic trunk native landing zone of appropriate length and diameter
- Appropriate take off angle between the Brachiocephalic Artery and the Aortic Arch
- Appropriate aortic arch perpendicular diameter
- Chronic dissection with specified conditions such as aneurysm ≥ 55 mm, rapid false lumen growth, or symptomatic
- Aneurysm with specified size or growth criteria or symptomatic
- Penetrating aortic ulcer that is symptomatic or expanding
- Intramural hematoma with symptoms or imaging expansion
- 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
- Candidate for elective surgery and considered high risk for open repair
- Compatible access vessels for vascular techniques and devices
- Willing and able to comply with study procedures and follow-up visits
You will not qualify if you...
- Acute dissection or vascular injury
- Lesions treatable with TEVAR landing in zone 2
- Required emergent treatment such as trauma or rupture
- Previous stent or stent graft in the treated area
- Planned or recent major surgical or interventional procedures unrelated to device placement
- Recent myocardial infarction or stroke within 90 days
- Severe aortic valvular insufficiency or mechanical valve preventing device delivery
- Known connective tissue diseases like Marfan's or Ehlers-Danlos
- Active systemic infection at procedure time
- Pregnancy
- Life expectancy less than 2 years
- Unsuitable vascular anatomy or previously implanted ascending aorta surgical wrap
- Medical conditions increasing risk from device or procedure
- Mycotic, inflammatory, or infected aneurysms
- Hostile groin or axilla anatomy unless conduit used
- Severe atherosclerosis, calcification, or intraluminal thrombus in aorta or brachiocephalic trunk
- Unstable angina or advanced heart failure
- Hypersensitivity or contraindication to anticoagulants, antiplatelets, contrast media, or device materials
- Contraindications to angiography
- Clinical conditions limiting x-ray visualization of the aorta
- History of bleeding disorders limiting antiplatelet or anticoagulant use
- Renal failure with elevated creatinine
- Other medical, social, or psychological issues precluding treatment
- Participation in conflicting clinical studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single procedure
Participants undergo the placement of the NEXUS Aortic Arch Stent Graft System to treat thoracic aortic lesions involving the aortic arch.
1 procedure visit (in-person)
Duration - 30 days
Participants are monitored after the stent graft placement to evaluate safety and effectiveness of the device.
Several follow-up visits within 30 days
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
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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