Clinical trial NCT04471909: NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Dissection
Aortic Aneurysm
Intramural Hematoma
Penetrating Aortic Ulcer
Lead sponsor: Endospan Ltd.
Sponsor class: INDUSTRY
First posted: 2020-07-15
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Device Technical Failure
timeFrame: 30 Days
measure: Clinical Failure
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: La Jolla
country: United States
facility: University of California San Diego Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Hartford
country: United States
facility: Hartford Healthcare
state: Connecticut
city: Orlando
country: United States
facility: Advent Health Orlando
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Carmel
country: United States
facility: Ascension St. Vincent
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: The Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Northwell Health Lenox Hill Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Research Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Kingsport
country: United States
facility: Ballad Health
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Plano
country: United States
facility: Baylor Scott and White
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Northwest
country: United States
facility: MedStar Washington Hospital
state: Washington
city: Auckland
country: New Zealand
facility: Auckland City Hospital
state: Grafton
Study officials:
References: