NEXUS Stent Graft for Aortic Disease (TRIOMPHE Trial)
Recruiting in Palo Alto (17 mi)
+32 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Endospan Ltd.
No Placebo Group
Approved in 1 jurisdiction
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.
12345Is 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.
12346How 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.
12345Eligibility 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
I have a blood clot within the walls of my blood vessels.
My heart surgery area is the right size for a new procedure.
I have an aneurysm with specific conditions.
I have a penetrating ulcer in my aorta.
My blood vessels are suitable for certain surgical procedures.
I have a long-term tear in my blood vessel wall.
Exclusion Criteria
I have severe heart problems, including unstable chest pain.
I currently have an infection with symptoms like pain, fever, or drainage.
I have severe hardening or blockage in my heart's arteries.
I cannot have an angiography due to health risks.
I needed emergency treatment for a sudden, severe condition.
I need surgery for a lower stomach artery bulge.
My kidney function is impaired with a creatinine level over 2.00 mg/dl.
My condition allows for a specific type of artery repair in my chest.
My aneurysm is caused by an infection.
I have had surgery involving a wrap around my ascending aorta.
I have an injury to my aorta from an accident.
I have an acute dissection.
I have severe aortic valve issues confirmed by an echo test.
My blood vessels are not suitable for certain medical procedures.
I do not have a ruptured aorta or an unstable aneurysm.
Participant Groups
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.
3Treatment groups
Experimental Treatment
Group I: Penetrating Aortic Ulcer and/or Intramural HematomaExperimental Treatment1 Intervention
Group II: Chronic DissectionExperimental Treatment1 Intervention
Group III: AneurysmExperimental Treatment1 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
UC Davis HealthSacramento, CA
University of Washington Medical CenterSeattle, WA
Baylor Scott and WhitePlano, TX
Duke University Medical CenterDurham, NC
More Trial Locations
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Who is running the clinical trial?
Endospan Ltd.Lead Sponsor
References
Three-year follow-up of aortic arch endovascular stent grafting with the Nexus device: results from a prospective multicentre study. [2023]Endovascular aortic arch stent grafting with branched devices has shown initial promising results. The aim of this prospective, multicentre study was to evaluate 3-year outcomes of aortic arch stent grafting with NEXUS® Aortic Arch Stent Graft System (Nexus), a single-branch, bi-modular, off-the-shelf aortic arch stent graft system in high-risk patients.
NEXUS Arch: A Multicenter Study Evaluating the Initial Experience With a Novel Aortic Arch Stent Graft System. [2023]To assess the initial clinical experience with a novel endograft system (NEXUS Aortic Arch Stent Graft System) designed to treat aortic arch pathologies and address the morphology and hemodynamic challenges of the aortic arch.
Total Endovascular Aortic Arch Repair: From Dream to Reality. [2022]The gold-standard therapy for the treatment of aortic arch pathologies is conventional open surgery. Recently, total endovascular aortic arch replacement with branched stent-grafts has been introduced into clinical practice with the aim of reducing invasiveness especially in selected high-risk patients. The aim of this review is to describe the two most commonly used branched devices for endovascular arch stent-grafting: Nexus (Endospan, Herzlia, Israle) and RelayBranch (Terumo Aortic, Glasgow, United Kingdom). Nexus is a CE-certified off-the-shelf, single branch, double stent graft system. It consists of two different components: a main module for the aortic arch and the descending aorta with a side-branch for the brachiocephalic artery (BCA), and a curved module for the ascending aorta that lands into the sino-tubular junction and connects to the main module through a side-facing self-protecting sleeve. Nexus may be used in urgent-emergency cases and also in patients with only one suitable supra-aortic target vessel but, on the other hand, it makes cerebral blood flow dependent on one source vessel only. The RelayBranch Thoracic Stent-Graft System is a custom made, double branched endograft with a wide window on its superior portion to accommodate two inner tunnels for BCA and left common carotid artery connection; bilateral cervical accesses are generally used to advance guidewires for catheterization of the inner tunnels in a retrograde fashion. RelayBranch can be customized on every patient's specific anatomy and provides a double blood source for the brain, but it cannot be used in urgent-emergency conditions. Therefore, in order to optimize outcomes, the choice of the most appropriate device should be made considering pros and cons of each system and patient's anatomy by an experienced aortic team. In conclusion, total endovascular aortic arch exclusion is a promising reality in selected high-risk patients.
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]The aim of this study was to evaluate the feasibility of an endovascular repair, using the NEXUS™ Aortic Arch Stent Graft System, in a real-world cohort of patients, treated with a Frozen Elephant Trunk (FET) procedure for pathology involving the aortic arch.
Modular branched stent graft for endovascular repair of aortic arch aneurysm and dissection. [2022]We describe a modular stent graft for use in endovascular repair of aneurysms of the aortic arch.
Endovascular Repair of Aortic Arch Aneurysm with a New Modular Double Inner Branch Stent Graft. [2022]Endovascular repair of an aortic arch aneurysm has made great progress in the last 10 years. Custom-made branched stent grafts have been used, and preliminary results have been promising. To reduce the effect of aortic arch anatomical variations on indications, we designed a new off-the-shelf modular double inner branch stent-graft system. This case is the "First-in-Man" study for the device. A 74-year-old man presented with an asymptomatic saccular aneurysm and an ulcer lesion of the aortic arch. Left common carotid artery (LCCA) and left subclavian artery bypass was performed before endovascular repair. The modular stents reconstructed the innominate artery and LCCA. A follow-up on the computed tomography angiography 6-month results showed that the new device is safe and feasible for patients who are unfit for conventional surgery.