TRIOMPHE 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: TRIOMPHE Study

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Aortic aneurysm, Aortic stenosis
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All genders
person-wave 18+
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Overview
Principal Investigator: Payam Salehi, MD and Yong Zhan, MD

The TRIOMPHE study is designed to further evaluate the safety and efficacy 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. NEXUS represents a novel, state-of-the-art technology that provides the unique benefit of endovascular treatment of thoracic aortic lesions involving the aortic arch including chronic dissections, aneurysms, PAU and IMH who surgical intervention are not expected to provide suitable benefit, given the associated risks of those procedures.

Study details
Inclusion Criteria
  • Chronic dissection with at least one of the following conditions: an aortic aneurysm with a maximum diameter ≥ 55 mm, rapidly expanding false lumen (growth of > 0.5 cm/6 months), compressed true lumen associated with end organ malperfusion, or symptomatic
  • Aneurysm with at least one of the following conditions: dilatation of the aortic arch larger than 5 cm in diameter for subject with fusiform aneurysm, dilatation of the aortic arch is 1.5 times the normal diameter for subjects ascending or descending, dilation of the aortic arch larger than 2.5 cm for subject with saccular aneurysm, symptomatic aneurysm of the aortic arch, aortic diameter growth rate > 5mm per 6 months, or postoperative pseudoaneurysm expanding from anastomotic suture lines
  • Penetrating aortic ulcer with at least one of the following: symptomatic or ulcer demonstrates expansion
Exclusion Criteria
  • 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
Study Requirements

We expect that you will be in this research study for a maximum of 60 months. You will need to visit the doctor's office for study follow-up visits approximately seven times over the course of the study. A total of 120 mL (approx. 8 tablespoons) of blood will be collected during the study period.