NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness

Aortic Aneurysm Clinical Trial

— TRIOMPHE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04471909
• Other study ID #: CIP-009
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: October 2029

Study information

• Verified date: March 2024
• Source: Endospan Ltd.
• Contact: Jessica Kleine
• Phone: +1 (612) 280-0208
• Email: j.kleine[@]endospan.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: October 2029
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Dissection
• Hematoma
• Intramural Hematoma
• Penetrating Aortic Ulcer

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Endospan Ltd.

Countries where clinical trial is conducted

United States,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device Technical Failure	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
Primary	Clinical Failure	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