TRIOMPHE
This study evaluates the safety and effectiveness of the NEXUS™ Aortic Arch Stent Graft System for treating thoracic aortic conditions involving the aortic arch. TRIOMPHE study.
About This Study
Summary
To evaluate the safety and effectiveness of the NEXUS™ Aortic Arch Stent Graft System for the endovascular treatment of thoracic aortic lesions involving the aortic arch, including chronic dissections, aneurysms, penetrating aortic ulcers and intramural hematoma.
To be included in TRIOMPHE, participants must be / have
- Male and female age ≥ 18
- Proximal/ascending native or previously implanted surgical graft landing zone length ≥ 30 mm
- Proximal/ascending native landing zone diameter: 30 ≤ ø ≤ 39 mm or surgical graft landing zone diameter: 26 ≤ ø ≤ 39 mm
- Distal/descending native landing zone length: ≥ 30 mm
- Distal/descending native landing zone diameter of:
- a. 26 ≤ ø ≤ 40 mm for aneurysms, PAU and IMH
- b. 28 ≤ ø ≤ 42 mm for chronic dissection
To be included in TRIOMPHE, participants must not be / have
- Acute dissection
- Lesions that can be safely treated with TEVAR landing in zone 2 (with or w/o LSA vascularization)
- Required emergent treatment, e.g., trauma, rupture
- Acute vascular injury of the aorta due to trauma
- Aortic rupture or unstable aneurysm
- Received a previous stent or stent graft in the treated area (including planned landing area)
CAUTION: Investigational Device – Limited by United States law to investigational use. Endospan devices bear the CE marking of conformity.
For More About This Study or To Ask About Participation
Additional Information
Lead scientist at Carilion Clinic
Dr. Esmaeel Reza Dadashzadeh is a dual board-certified vascular surgeon with a strong background in both clinical care and research. He’s currently the interim director of the Carilion Clinic Aortic Center and interim section chief of aortic and endovascular surgery. In addition to his clinical roles, he’s an assistant professor of aortic and endovascular surgery at Virginia Tech Carilion School of Medicine.
Dr. Dadashzadeh completed his vascular surgery fellowship at Washington University in St. Louis and his general surgery residency at the University of Pittsburgh Medical Center. He also holds a master’s in biomedical informatics from the University of Pittsburgh.
Official title of study
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