NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness (TRIOMPHE)

March 14, 2024 updated by: Endospan Ltd.

A Multi-arm, Multi-Center, Non-Randomized, Prospective, Clinical Study to Evaluate the Safety and Effectiveness of the NEXUS Aortic Arch Stent Graft System in Treating Thoracic Aortic Lesions Involving the Aortic Arch

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • New Zealand
    • Grafton
      • Auckland, Grafton, New Zealand, 1023
        • Recruiting
        • Auckland City Hospital
        • Principal Investigator:
          • Andrew Holden, Prof.
        • Principal Investigator:
          • Andrew Hill, Dr.
        • Contact:
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama Birmingham
        • Contact:
        • Principal Investigator:
          • Adam Beck, M.D
        • Principal Investigator:
          • Kyle Eudailey, M.D
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • University of California San Diego Medical Center
        • Principal Investigator:
          • John Lane, M.D.
        • Principal Investigator:
          • Eugene Golts, M.D.
        • Contact:
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University School of Medicine
        • Contact:
        • Principal Investigator:
          • Claire Watkins, M.D.
        • Principal Investigator:
          • Jason Lee, M.D.
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado
        • Principal Investigator:
          • Brett Reece, M.D.
        • Principal Investigator:
          • Donald Jacobs, M.D.
        • Contact:
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Recruiting
        • Hartford Healthcare
        • Principal Investigator:
          • Mohiuddin Cheema
        • Principal Investigator:
          • James Gallagher
        • Contact:
    • Florida
      • Orlando, Florida, United States, 32804
        • Recruiting
        • Advent Health Orlando
        • Contact:
        • Principal Investigator:
          • Manuel Perez
        • Principal Investigator:
          • Ahmad Zeeshan
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
        • Principal Investigator:
          • Bradley Leshnower, M.D
        • Principal Investigator:
          • Yazan Duwayri, M.D
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • The University of Chicago
        • Principal Investigator:
          • Trissa Babrowski, M.D
        • Principal Investigator:
          • Takeyoshi Ota, M.D
        • Contact:
    • Indiana
      • Carmel, Indiana, United States, 46290
        • Recruiting
        • Ascension St. Vincent
        • Contact:
        • Principal Investigator:
          • Sina Moainie
        • Principal Investigator:
          • Brent Mardsen
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland
        • Principal Investigator:
          • Bradley Taylor, M.D
        • Principal Investigator:
          • Shahab Toursavadkohi, M.D
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Tufts Medical Center
        • Contact:
        • Principal Investigator:
          • Payam Salehi
        • Principal Investigator:
          • Yong Zhan
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • Himanshu Patel, M.D
        • Principal Investigator:
          • David Williams, M.D
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • John Ohman, M.D
        • Principal Investigator:
          • Puja Kachroo, M.D
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • The Mount Sinai Medical Center
        • Principal Investigator:
          • Ismail El-Hamamsy
        • Contact:
        • Principal Investigator:
          • Rami Tadros
      • New York, New York, United States, 10075
        • Recruiting
        • Northwell Health Lenox Hill Hospital
        • Principal Investigator:
          • Derek Brinster, M.D
        • Principal Investigator:
          • Alfio Carroccio, M.D
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina
        • Contact:
        • Principal Investigator:
          • Mark Farber
        • Principal Investigator:
          • Thomas Caranasos
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Atrium Health
        • Contact:
        • Principal Investigator:
          • Frank Arko, M.D.
        • Principal Investigator:
          • John Frederick, M.D.
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Contact:
        • Principal Investigator:
          • Chad Hughes, M.D.
        • Principal Investigator:
          • Chandler Long, M.D.
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • The Lindner Research Center
        • Principal Investigator:
          • Geoffrey Answini, M.D.
        • Principal Investigator:
          • Mark Harding, M.D.
        • Contact:
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospital
        • Principal Investigator:
          • Jae Cho
        • Contact:
        • Principal Investigator:
          • Yakov Elgudin
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health
        • Principal Investigator:
          • Castigliano Bhamidipati, M.D.
        • Principal Investigator:
          • Cherrie Abraham, M.D.
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Lankenau Medical Center
        • Principal Investigator:
          • Robert Rodriguez, M.D
        • Principal Investigator:
          • William Gray, M.D
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Sanford Zeigler, M.D.
        • Principal Investigator:
          • Ravi Veeraswamy, M.D.
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Recruiting
        • Ballad Health
        • Contact:
        • Principal Investigator:
          • Robert Allen
        • Principal Investigator:
          • Bryan Helsel
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
        • Principal Investigator:
          • Melissa Levack
        • Principal Investigator:
          • Daniel Clair
    • Texas
      • Plano, Texas, United States, 75093
        • Recruiting
        • Baylor Scott and White
        • Principal Investigator:
          • William Brinkman, M.D
        • Principal Investigator:
          • Dennis Gable, M.D
        • Contact:
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Sentara Norfolk General Hospital
        • Principal Investigator:
          • Christopher Barreiro, M.D.
        • Principal Investigator:
          • Jean Panneton, M.D.
        • Contact:
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Carilion Clinic
        • Contact:
        • Principal Investigator:
          • Joshua Adams
        • Principal Investigator:
          • Joseph Rowe
    • Washington
      • Northwest, Washington, United States, 20010
        • Recruiting
        • MedStar Washington Hospital
        • Contact:
        • Principal Investigator:
          • Javairiah Fatima, M.D
        • Principal Investigator:
          • Christian Shults, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chronic Dissection
Device: NEXUS Aortic Stent Graft System

Arch Stent Graft, whose cranial narrow end is intended to be deployed into the Brachiocephalic artery and whose distal end is intended to be deployed into the Descending Thoracic Aorta.

Ascending Stent Graft intended to be deployed in the Ascending Aorta.

OPTIONAL: Descending Extension can be used in case the aortic lesion elongates further distally and out of the covered length offered by the Arch Stent Graft. Multiple Descending Extensions can be used if needed to cover the entire length of the lesion.
Experimental: Aneurysm
Device: NEXUS Aortic Stent Graft System

Arch Stent Graft, whose cranial narrow end is intended to be deployed into the Brachiocephalic artery and whose distal end is intended to be deployed into the Descending Thoracic Aorta.

Ascending Stent Graft intended to be deployed in the Ascending Aorta.

OPTIONAL: Descending Extension can be used in case the aortic lesion elongates further distally and out of the covered length offered by the Arch Stent Graft. Multiple Descending Extensions can be used if needed to cover the entire length of the lesion.
Experimental: Penetrating Aortic Ulcer and/or Intramural Hematoma
Device: NEXUS Aortic Stent Graft System

Arch Stent Graft, whose cranial narrow end is intended to be deployed into the Brachiocephalic artery and whose distal end is intended to be deployed into the Descending Thoracic Aorta.

Ascending Stent Graft intended to be deployed in the Ascending Aorta.

OPTIONAL: Descending Extension can be used in case the aortic lesion elongates further distally and out of the covered length offered by the Arch Stent Graft. Multiple Descending Extensions can be used if needed to cover the entire length of the lesion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Technical Failure
Time Frame: 30 Days
  • Failure to accurately deliver, track and deploy all required endovascular device components at the intended implantation site and failure to retrieve the device delivery systems without the need for unplanned additional procedures
  • Device occlusion
  • Failed exclusion of primary entry tear
  • Additional unanticipated surgical or interventional procedure related to the device or procedure, to prevent life-threatening or permanent disabling event.
30 Days
Clinical Failure
Time Frame: 30 Days
Subjects experiencing early mortality or at least one of the following MAEs through 30-Day of Phase 1 Procedure and 30-Day of Index Procedure: Disabling stroke, permanent paralysis/paraplegia, renal failure, aortic rupture, development of new dissections in the thoracic aorta or brachiocephalic artery.
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endospan Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2020

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

July 9, 2020

First Submitted That Met QC Criteria

July 14, 2020

First Posted (Actual)

July 15, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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