HVP_CP-0008 EVAS2

HVP Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study of Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System

The objective of this study is to assess the safety and effectiveness of the Endologix Nellix® System for the endovascular repair of infrarenal abdominal aortic aneurysms (AAA).

Key Inclusion Criteria:
1. At least 18 years old; Informed consent understood and signed;
2. Patient agrees to all follow-up visits;
3. Have AAA with sac diameter ≥5.0cm, or ≥4.5 cm which has increased by >1.0cm in the past year.
4. Anatomic eligibility for the Nellix System per the instructions for use:
5. Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥6 mm);
6. Aneurysm blood lumen diameter ≤60mm;
7. Most caudal renal artery to aortoiliac bifurcation length ≥100mm;
8. Proximal non-aneurysmal aortic neck: length ≥10mm; lumen diameter 18 to 32mm; angle ≤60° to the aneurysm sac;
9. Common iliac artery lumen diameter between 9 and 35mm with blood lumen diameter ≤35mm;
10. Ability to preserve at least one hypogastric artery.

**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
IDE
NCT03298477
Heart and Vascular
Surgery
Brant Ullery, M.D.
Endologix, Inc
Michelle Dixon
  • Providence Portland Medical Center
  • Providence St. Vincent Medical Center