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

Completed

• Conditions: dilatation of the abdominal aorta; Enlarged artery of the abdominal aorta; 10002363

• Registration Number: NL-OMON38484
• Lead Sponsor: Endologix, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2022-12-07
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

*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.

Exclusion Criteria

* 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified