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New stent graft could fix deadly aortic arch conditions

NCT ID NCT04471909

Disease control Sponsor: Endospan Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new device called the NEXUS aortic arch stent graft system in 110 adults with serious conditions like aortic dissection or aneurysm affecting the aortic arch. The goal is to see if it is safe and effective at repairing the damaged area without major complications. Participants must meet specific size requirements for the stent placement areas.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2020

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male and female age ≥ 18. 2. Proximal/ascending native or previously implanted surgical graft landing zone of appropriate length 3. Proximal/ascending native or previously implanted surgical graft landing zone of appropriate diameter 4. Distal/descending native landing zone of appropriate length 5. Distal/descending native landing zone of appropriate diameter 6. Brachiocephalic trunk native landing zone of appropriate length 7. Brachiocephalic trunk native landing zone of appropriate diameter 8. Appropriate take off angle between the Brachiocephalic Artery and the Aortic Arch perpendicular 9. Appropriate aortic arch perpendicular diameter 10. Chronic dissection with at least one of the following conditions: 1. An aortic aneurysm with a maximum diameter ≥ 55 mm 2. Rapidly expanding false lumen (growth of \> 0.5 cm/6 months) 3. Compressed true lumen associated with end organ malperfusion 4. Symptomatic 11. Aneurysm with at least one of the following conditions: 1. Dilatation of the aortic arch larger than 5 cm in diameter for subject with fusiform aneurysm 2. Dilatation of the aortic arch is 1.5 times the normal diameter for subjects ascending or descending 3. Dilation of the aortic arch larger than 2.5 cm for subject with saccular aneurysm 4. Symptomatic aneurysm of the aortic arch 5. Aortic diameter growth rate \> 5mm per 6 months 6. Postoperative pseudoaneurysm expanding from anastomotic suture lines 12. Penetrating aortic ulcer with at least one of the following: 1. Symptomatic 2. Ulcer demonstrates expansion 13. Intramural hematoma with at least one of the following: 1. Symptomatic (persistent pain) 2. Transverse or longitudinal expansion on serial imaging 14. In the event of a lesion in the ascending aortic, the proximal/ascending native or previously implanted surgical graft the landing zone must be appropriate 15. Femoral / iliac artery diameter as documented by CTA or MRA that allows endovascular access to the diseased site with a 20 Fr. delivery catheter. 16. Access vessels morphology suitable for endovascular repair in terms of tortuosity, calcification and angulation, documented by CTA/MRA. 17. Brachial/Axial Artery diameter that allows endovascular access suitable for 7 Fr. 18. Subject is considered an appropriate candidate for an elective surgery. 19. Subject is considered to be at high risk for open repair, as determined by the investigator. 20. Access vessels, iliac/femoral \& brachial/axillary compatible with vascular access techniques (femoral cutdown or percutaneous), devices, and /or accessories. 21. Subject is willing and able to comply with procedures specified in the protocol and is able to return for follow-up visits as specified by the protocol. Exclusion Criteria: 1. Acute dissection 2. Lesions that can be safely treated with TEVAR landing in zone 2 (with or w/o LSA vascularization) 3. Required emergent treatment, e.g., trauma, rupture 4. Acute vascular injury of the aorta due to trauma 5. Aortic rupture or unstable aneurysm 6. Received a previous stent or stent graft in the treated area (including planned landing area) 7. Required surgical or endovascular treatment of an infra-renal aneurysm at time of implantation 8. Planned major surgical or interventional procedure at time of screening, to be performed after the NEXUS™ implantation. 9. Any major surgical or interventional procedure 6 weeks before the NEXUS™ implantation, exclusive of planned procedures that are needed for the safe and effective placement of the stent graft (e.g. supra-aortic bypass). 10. Subject has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 90 days prior to the planned implantation 11. Subjects with severe aortic valvular insufficiency as determined by echocardiography 12. Mechanical valve that preclude safe delivery of NEXUS™ 13. Known Connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndromes) 14. Subject has an active systemic infection at the time of the procedure documented by pain, fever, drainage, positive culture 15. Pregnant 16. Life expectancy of less than 2 years 17. Unsuitable vascular anatomy 18. Subject who have a previously implanted surgical wrap of the ascending aorta 19. Any medical condition that, according to the investigator's decision, might expose the subject to increased risk by the investigational device or procedure. 20. An aneurysm that is mycotic, inflammatory or suspected to be infected. 21. Subject with hostile groins/axilla (scarring, obesity, or previous failed puncture) unless conduit are used. 22. Subjects with severe atherosclerosis, severe calcification or extensive intraluminal thrombus of the aorta or in the brachiocephalic trunk 23. Subject is suffering from unstable angina or NYHA classification III and IV. 24. Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment. 25. Subject with a contraindication to undergo angiography 26. Subject with known sensitivities or allergies to the device materials (including Nitinol \[NiTi\], polyester fabric \[PET\], tantalum \[TA\]) 27. Clinical conditions that severely inhibit x-ray visualization of the Aorta. 28. Subject has history of bleeding diathesis or coagulopathy that may limit the use of dual antiplatelet or anticoagulant therapy by the decision of the investigator 29. Acute renal failure; chronic renal failure (excluding dialysis); Creatinine \> 2.00 mg/dl 30. Any other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, or the procedures and evaluations pre- and post- treatment. 31. Active participation in another clinical study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints in this study, or subject is planning to participate in such study prior to the completion of this study.

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Conditions

The condition(s) this trial relates to.

aortic aneurysm Aortic Dissection Penetrating Atherosclerotic Ulcer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic aneurysm Aortic dissection Intramural hematoma Penetrating aortic ulcer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    25 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advent Health Orlando

    COMPLETED

    Orlando, Florida, 32804, United States

  • Ascension St. Vincent

    COMPLETED

    Carmel, Indiana, 46290, United States

  • Atrium Health

    RECRUITING

    Charlotte, North Carolina, 28203, United States

  • Auckland City Hospital

    RECRUITING

    Auckland, Grafton, 1023, New Zealand

  • Ballad Health

    COMPLETED

    Kingsport, Tennessee, 37660, United States

  • Baylor Scott and White

    RECRUITING

    Plano, Texas, 75093, United States

  • Carilion Clinic

    RECRUITING

    Roanoke, Virginia, 24014, United States

  • Duke University Medical Center

    COMPLETED

    Durham, North Carolina, 27710, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Hartford Hospital

    RECRUITING

    Hartford, Connecticut, 06102, United States

  • Lankenau Medical Center

    COMPLETED

    Wynnewood, Pennsylvania, 19096, United States

  • MedStar Washington Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Northwell Health Lenox Hill Hospital

    RECRUITING

    New York, New York, 10075, United States

  • Oregon Health

    RECRUITING

    Portland, Oregon, 97239, United States

  • Sentara Norfolk General Hospital

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • Stanford University School of Medicine

    RECRUITING

    Stanford, California, 94305, United States

  • The Lindner Research Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • The Mount Sinai Medical Center

    RECRUITING

    New York, New York, 10029, United States

  • The University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • Tufts Medical Center

    COMPLETED

    Boston, Massachusetts, 02111, United States

  • UC Davis Health

    COMPLETED

    Sacramento, California, 95817, United States

  • University Hospitals of Cleveland

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Alabama Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of California San Diego Medical Center

    RECRUITING

    La Jolla, California, 92037, United States

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Maryland

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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