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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04471909




Registration number
NCT04471909
Ethics application status
Date submitted
9/07/2020
Date registered
15/07/2020
Date last updated
19/09/2024

Titles & IDs
Public title
NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness
Scientific 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
Secondary ID [1] 0 0
CIP-009
Universal Trial Number (UTN)
Trial acronym
TRIOMPHE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Dissection 0 0
Aortic Aneurysm 0 0
Intramural Hematoma 0 0
Penetrating Aortic Ulcer 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Other blood disorders
Injuries and Accidents 0 0 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - NEXUS Aortic Stent Graft System

Experimental: Chronic Dissection -

Experimental: Aneurysm -

Experimental: Penetrating Aortic Ulcer and/or Intramural Hematoma -


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Device Technical Failure
Timepoint [1] 0 0
30 Days
Primary outcome [2] 0 0
Clinical Failure
Timepoint [2] 0 0
30 Days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2029
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
New Zealand
State/province [23] 0 0
Grafton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Endospan Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04471909
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jessica Kleine
Address 0 0
Country 0 0
Phone 0 0
+1 (612) 280-0208
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04471909