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

Endologix, Inc0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•*Male or female at least 18 years old;
•*Informed consent understood and signed;
•*Patient agrees to all follow-up visits;
•*Have an infrarenal abdominal aortic aneurysm (AAA) with maximum sac diameter *5.5cm, or an infrarenal AAA * 4.5 cm which has increased by >1.0cm in the past year.
•*Anatomic eligibility for the Nellix System per the instructions for use:
•oAdequate iliac/femoral access compatible with the required delivery systems (diameter 6 mm);
•oAneurysm blood lumen diameter *60mm;
•oProximal non-aneurysmal aortic neck:
•* length 10mm;
•* lumen diameter 16 to 32mm;
•* angle 60° to the aneurysm sac;
•oMost caudal renal artery to each hypogastric artery length 100mm;
•oCommon iliac artery lumen diameter between 8 and 35mm;
•oAbility to preserve at least one hypogastric artery.

•* Life expectancy <2 years;
•* Psychiatric or other condition that may interfere with the study;
•* Participating in another clinical study
•* Known allergy to device any device component;
•* Coagulopathy or uncontrolled bleeding disorder;
•* Ruptured, leaking or mycotic aneurysm;
•* Serum creatinine level >2.0mg/dL;
•* CVA or MI within three months of enrollment/treatment;
•* Aneurysmal disease of the descending thoracic aorta;
•* Clinically significant infrarenal mural thrombus (>5mm thickness over >50% circumference);
•* Connective tissue diseases (e.g., Marfan Syndrome)
•* Unsuitable vascular anatomy;
•* Pregnant (females of childbearing potential only).

发起方