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

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ClinicalTrials.gov Identifier: NCT04471909
Recruitment Status : Recruiting
First Posted : July 15, 2020
Last Update Posted : February 16, 2021
Sponsor:
Information provided by (Responsible Party):
Endospan Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Aortic Dissection Aortic Aneurysm Intramural Hematoma Penetrating Aortic Ulcer Device: NEXUS Aortic Stent Graft System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 20, 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : January 2027

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.





Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04471909


Contacts
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Contact: Jessica Kleine (612)2800208 j.Kleine@endospan.com
Contact: Jennifer Miller j.miller@endospan.com

Locations
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United States, Alabama
University of Alabama Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Rebecca St. John       rstjohn@uabmc.edu   
Principal Investigator: Adam Beck, M.D         
Principal Investigator: Kyle Eudailey, M.D         
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Tiffany Koyano    650-724-6921    tkoyano3@stanford.edu   
Principal Investigator: Claire Watkins, M.D.         
Principal Investigator: Jason Lee, M.D.         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Jayne Thompson       sjdanle@emory.edu   
Principal Investigator: Bradley Leshnower, M.D         
Principal Investigator: Yazan Duwayri, M.D         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Matthew Audette    410-328-8149    maudette@som.umaryland.edu   
Principal Investigator: Bradley Taylor, M.D         
Principal Investigator: Shahab Toursavadkohi, M.D         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Amanda Kasperek       kasperea@med.umich.edu   
Principal Investigator: Himanshu Patel, M.D         
Principal Investigator: David Williams, M.D         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Julie Wilson       wilsonj@wustl.edu   
Principal Investigator: Luis Sanchez, M.D         
Principal Investigator: Marc Moon, M.D         
United States, New York
Northwell Health Lenox Hill Hospital Recruiting
New York, New York, United States, 10075
Contact: Claire Sarmiento       Isarmient1@northwell.edu   
Principal Investigator: Derek Brinster, M.D         
Principal Investigator: Alfio Carroccio, M.D         
United States, North Carolina
Atrium Health Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Sally Aberle    704-355-4794    Sally.Aberle@atriumhealth.org   
Principal Investigator: Frank Arko, M.D.         
Principal Investigator: John Frederick, M.D.         
United States, Ohio
The Lindner Research Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: David White       david.white@thechristhospital.com   
Principal Investigator: Geoffrey Answini, M.D.         
Principal Investigator: Mark Harding, M.D.         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Madeline Koelsch       Madeline.Koelsch@pennmedicine.upenn.edu   
Principal Investigator: Nimesh Desai, M.D.         
Principal Investigator: Grace Wang, M.D.         
United States, Virginia
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Melinda Bullivant    757-388-4024    MMBULLIV@sentara.com   
Principal Investigator: Christopher Barreiro, M.D.         
Principal Investigator: Jean Panneton, M.D.         
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Carly Mondoy-Loxton       carlyml@uw.edu   
Principal Investigator: Matthew Sweet, M.D         
Principal Investigator: Christopher Burke         
New Zealand
Auckland City Hospital Recruiting
Auckland, Grafton, New Zealand, 1023
Contact: Elleni Takele    09 307 4949 ext 21976    ElleniT@adhb.govt.nz   
Contact: Hank Zhang       HankZ@adhb.govt.nz   
Principal Investigator: Andrew Holden, Prof.         
Principal Investigator: Andrew Hill, Dr.         
Sponsors and Collaborators
Endospan Ltd.
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Responsible Party: Endospan Ltd.
ClinicalTrials.gov Identifier: NCT04471909    
Other Study ID Numbers: CIP-009
First Posted: July 15, 2020    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aneurysm, Dissecting
Hematoma
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Hemorrhage
Pathologic Processes