NEXUS Stent Graft for Aortic Disease

(TRIOMPHE Trial)

Recruiting at 32 trial locations

Overseen By Carrie MacNabb

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Endospan Ltd.

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Acute dissection, Aortic rupture, Pregnancy, Severe atherosclerosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

110 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, this may affect your eligibility.

What data supports the effectiveness of the NEXUS Stent Graft System treatment for aortic disease?

Research shows that the NEXUS Stent Graft System has promising results for treating aortic arch issues, especially in high-risk patients, with positive outcomes observed over a three-year period. This system is designed to be less invasive than traditional surgery, making it a good option for patients who may not be able to undergo more invasive procedures. ^{1 2 3 4 5}

Is the NEXUS Stent Graft generally safe for humans?

The NEXUS Stent Graft has shown promising safety results in studies, including a three-year follow-up study and initial clinical experiences, especially in high-risk patients who are not suitable for conventional surgery. ^{1 2 3 4 6}

How is the NEXUS Stent Graft treatment different from other treatments for aortic disease?

The NEXUS Stent Graft is unique because it is an off-the-shelf, single-branch, bi-modular system designed for endovascular repair of the aortic arch, making it less invasive than traditional open surgery. It is particularly suitable for high-risk patients and can be used in urgent situations, although it relies on a single blood source for the brain, unlike some other systems that provide dual blood sources. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults over 18 with certain aortic conditions like aneurysms or dissections, who are high-risk candidates for open surgery. They must have suitable anatomy for the NEXUS Stent Graft System and be able to follow study procedures. Pregnant individuals, those with recent major surgeries or heart attacks, severe infections, or known allergies to device materials cannot participate.

Inclusion Criteria

The lower part of the main blood vessel where the device will be placed should be long enough.

I have a blood clot within the walls of my blood vessels.

My artery size is suitable for a specific medical procedure.

Exclusion Criteria

You have scarring, obesity, or previous failed puncture in the groin or armpit area, unless other methods are used for the procedure.

You have a known connective tissue disease such as Marfan's or Ehlers-Danlos syndromes.

I am scheduled for a major surgery after getting a NEXUS™ implant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the NEXUS Aortic Arch Stent Graft System for the treatment of thoracic aortic lesions

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of clinical failure and device technical failure

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• NEXUS Aortic Stent Graft System

Trial Overview The NEXUS Aortic Arch Clinical Study tests the safety and effectiveness of the NEXUS Aortic Stent Graft System in treating thoracic aortic lesions involving the arch. It's non-randomized and multi-center, focusing on patients with specific anatomical features suitable for this elective endovascular repair procedure.

Participant Groups

Group I: Penetrating Aortic Ulcer and/or Intramural Hematoma Experimental Treatment 1 Intervention

Group II: Chronic Dissection Experimental Treatment 1 Intervention

Group III: Aneurysm Experimental Treatment 1 Intervention

NEXUS Aortic Stent Graft System is already approved in European Union for the following indications:

Approved in European Union as NEXUS Aortic Arch Stent Graft System for:

• Thoracic aortic lesions involving the aortic arch
• Aortic arch aneurysms
• Chronic aortic dissections

Who Is Running the Clinical Trial?

Endospan Ltd.

Lead Sponsor

Trials

6

Recruited

230+

Findings from Research

In a study of 28 high-risk patients, the NEXUS® Aortic Arch Stent Graft System demonstrated a 3-year overall survival rate of 71%, with no device or procedure-related deaths reported during this period.

The procedure showed a low incidence of serious complications, with no strokes, paraplegia, or myocardial infarctions, although some endoleaks were detected, indicating the need for ongoing monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-year follow-up of aortic arch endovascular stent grafting with the Nexus device: results from a prospective multicentre study. D'Onofrio, A., Lachat, M., Mangialardi, N., et al.[2023]

The NEXUS Aortic Arch Stent Graft System demonstrated a 100% procedural success rate in 28 patients, effectively treating aortic arch pathologies with a high rate of vascular pathology exclusion (96.1%) at 1 month post-procedure.

At 1 year, the system showed promising safety outcomes with a mortality rate of 10.7% and a combined mortality/stroke rate of 17.8%, indicating it is a viable option for endovascular aortic arch repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NEXUS Arch: A Multicenter Study Evaluating the Initial Experience With a Novel Aortic Arch Stent Graft System. Planer, D., Elbaz-Greener, G., Mangialardi, N., et al.[2023]

Total endovascular aortic arch replacement using branched stent-grafts, like Nexus and RelayBranch, offers a less invasive alternative to traditional open surgery, particularly beneficial for high-risk patients.

Nexus is suitable for urgent cases but relies on a single blood source for the brain, while RelayBranch provides a double blood source but is not for emergency use, highlighting the importance of tailored device selection based on patient anatomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total Endovascular Aortic Arch Repair: From Dream to Reality. D'Onofrio, A., Caraffa, R., Cibin, G., et al.[2022]

In a study of 37 patients treated with the Frozen Elephant Trunk procedure, only 18.9% were eligible for endovascular repair using the NEXUS Aortic Arch Stent Graft System, indicating limited feasibility in this cohort.

The suitability of the stent graft was highest in patients with aortic arch aneurysms (47.1%), suggesting that the device may be more applicable for this specific condition compared to others like acute dissections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anatomical feasibility of an endovascular aortic arch repair with the NEXUS endograft in patients treated with a frozen elephant trunk procedure for aortic arch pathology. Exelmans, W., Mufty, H., Maleux, G., et al.[2023]

A new modular stent graft has been developed for endovascular repair of aortic arch aneurysms, utilizing a bifurcated proximal component and a distal component for effective deployment.

This innovative system has been successfully used to treat a large wide-necked pseudoaneurysm, demonstrating its potential efficacy in complex aortic repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modular branched stent graft for endovascular repair of aortic arch aneurysm and dissection. Chuter, TA., Schneider, DB., Reilly, LM., et al.[2022]

The study introduces a new off-the-shelf modular double inner branch stent-graft system for endovascular repair of aortic arch aneurysms, showing promising preliminary results in a 'First-in-Man' case involving a 74-year-old patient.

Follow-up imaging at 6 months demonstrated that the device is safe and feasible for patients who are not suitable for traditional surgical options, indicating its potential as a viable alternative treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular Repair of Aortic Arch Aneurysm with a New Modular Double Inner Branch Stent Graft. Guo, W., Zhang, H., Liu, X., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Three-year follow-up of aortic arch endovascular stent grafting with the Nexus device: results from a prospective multicentre study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

NEXUS Arch: A Multicenter Study Evaluating the Initial Experience With a Novel Aortic Arch Stent Graft System. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Total Endovascular Aortic Arch Repair: From Dream to Reality. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Anatomical feasibility of an endovascular aortic arch repair with the NEXUS endograft in patients treated with a frozen elephant trunk procedure for aortic arch pathology. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Modular branched stent graft for endovascular repair of aortic arch aneurysm and dissection. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Endovascular Repair of Aortic Arch Aneurysm with a New Modular Double Inner Branch Stent Graft. [2022]