NEXUS Stent Graft for Aortic Disease

(TRIOMPHE Trial)

Recruiting at 30 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medical device called the NEXUS Aortic Stent Graft System. It is designed to assist individuals with specific conditions affecting the thoracic aorta, a major blood vessel in the chest. The trial targets those with chronic dissection, aortic aneurysms, or penetrating ulcers, which can lead to serious complications. Individuals who have experienced symptoms like persistent pain or changes in their aortic condition might be suitable candidates. The trial aims to determine if this device can safely and effectively treat these conditions. As an unphased trial, it provides a unique opportunity for patients to contribute to groundbreaking research that could enhance treatment options for aortic conditions.

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 prior data suggests that the NEXUS Aortic Stent Graft System is safe for treating thoracic aortic lesions?

Research has shown that the NEXUS Aortic Stent Graft System is generally well-tolerated by patients. Studies suggest it could be a safer option than traditional open-heart surgery for repairing parts of the aorta, a major artery. For instance, one study found that patients experienced positive results within the first 30 days of using the NEXUS system, with no major complications.

Another study from Italy also supported its safety. Patients who received the NEXUS system for conditions like aortic dissection (a tear in the aorta) or aneurysm (a bulge in the aorta) experienced good outcomes with few complications. This suggests that the device is a safe choice for these serious conditions.

These findings build confidence in the safety of the NEXUS system for treating aortic problems. However, like any medical procedure, risks exist, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The NEXUS Aortic Stent Graft System stands out because it offers a minimally invasive solution for aortic disease, such as aneurysms and dissections, which are typically addressed through open surgery or traditional stent grafts. This system is specifically designed to handle complex aortic anatomies, potentially reducing the risk of complications and improving patient recovery time. Researchers are excited about its innovative design, which could offer greater precision and flexibility in treating these serious conditions, potentially leading to better outcomes for patients.

What evidence suggests that the NEXUS Aortic Stent Graft System is effective for treating thoracic aortic lesions?

Research has shown that the NEXUS Aortic Arch Stent Graft System could effectively treat issues in the aortic arch, a section of the main artery. Participants in this trial will be assigned to different treatment arms based on their specific aortic condition, such as Penetrating Aortic Ulcer and/or Intramural Hematoma. One study suggested early on that this system is safe and effective for addressing issues like tears or bulges in the artery wall. Another report showed positive results 30 days after the procedure, indicating it could be a promising choice for patients. The system is designed to be less invasive, potentially offering a safer alternative to traditional surgeries. Overall, initial findings suggest the NEXUS system effectively repairs problems in the upper part of the aorta. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Group II: Chronic Dissection (arm closed to enrollment) Experimental Treatment 1 Intervention

Group III: Aneurysm (arm closed to enrollment) 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+

Published Research Related to This Trial

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04471909

Study Details | NCT04471909 | NEXUS Aortic Arch ... Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch Stent Graft System (NEXUSTM) for the treatment of thoracic aortic ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33714965/

NEXUS Arch: A Multicenter Study Evaluating the Initial ... The NEXUS Aortic Arch Stent Graft System, a novel single branch, 2 stent graft system used for endovascular aortic arch repair that requires ...

3. evtoday.com evtoday.com/news/endospans-nexus-aortic-arch-stent-graft-system-evaluated-in-30-day-triomphe-data

Endospan's Nexus Aortic Arch Stent Graft System ... According to the Israel-based company, the 30-day results are promising for aortic arch treatment in Zone 0 with Nexus and suggest that the ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0741521425012820

Results from the Italian Nexus aRCH endovascular repair ... The use of the Nexus and Nexus Duo endograft systems appears to be a safe option for the treatment of aortic arch dissection and aneurysm, with complication ...

5. endospan.com endospan.com/patient-information

NEXUS® Aortic Arch Stent Graft | Minimally-Invasive ... The NEXUS Aortic Arch Stent Graft System was specifically engineered for minimally-invasive total arch repair to overcome the challenges of the aortic arch ...