Status:
ACTIVE_NOT_RECRUITING
EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study
Lead Sponsor:
Endologix
Conditions:
Abdominal Aortic Aneurysm Without Rupture
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.
Detailed Description
This study will evaluate the safety and effectiveness of the Nellix System among a wide range of physicians and in consecutively enrolled subjects to assess safety and effectiveness outcomes. Followin...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- A patient who meets all of the following criteria potentially may be included in the study:
- Male or female at least 18 years old;
- Informed consent form understood and signed
- Patient agrees to all follow-up visits;
- Abdominal aortic aneurysm with sac diameter ≥5.0cm, or ≥4.5cm which has increased by ≥0.5cm within the last 6 months, or or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA \<4 cm will be included.
- Anatomically eligible for the Nellix System (per Instructions For Use):
- Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥6 mm);
- Aneurysm blood lumen diameter ≤60mm;
- Proximal non-aneurysmal aortic neck: length ≥10mm; diameter 18 to 28mm; angle ≤60° to the aneurysm sac;
- Most caudal renal artery to each hypogastric artery length ≥100mm;
- Common iliac artery lumen diameter between 9 and 35mm;
- Distal iliac artery seal zone with length of ≥10mm and diameter range of 9 to 25mm;
- Ability to preserve at least one hypogastric artery.
- Ratio of maximum aortic aneurysm diameter to maximum aortic blood lumen diameter \<1.40
- EXCLUSION CRITERIA
- A patient who meets none of the following criteria potentially may be included in the study:
- Life expectancy \<2 years as judged by the Investigator;
- Psychiatric or other condition that may interfere with the study;
- Participating in another clinical study;
- Known allergy or contraindication to any device material;
- Coagulopathy or uncontrolled bleeding disorder;
- Ruptured, leaking or mycotic aneurysm;
- Serum creatinine (S-Cr) level \>2.0 mg/dL;
- CVA or MI within three months of enrollment/treatment;
- Aneurysmal disease of the descending thoracic aorta;
- Clinically significant mural thrombus within the proximal landing zone (minimum 10mm) of the infrarenal non-aneurysmal neck (\>5mm thickness over \>50% circumference);
- Connective tissue diseases (e.g., Marfan Syndrome);
- Unsuitable vascular anatomy that may interfere with device introduction or deployment;
- Pregnant (female of childbearing potential only).
Exclusion
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2025
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT03298477
Start Date
December 1 2017
End Date
August 16 2025
Last Update
March 19 2025
Active Locations (27)
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1
Valley Vascular Consultants
Huntsville, Alabama, United States, 35801
2
Regents of the University of California (UCLA)
Los Angeles, California, United States, 90095
3
Veterans Medical Research Foundation
San Diego, California, United States, 92161
4
UC Health-Memorial Hospital
Colorado Springs, Colorado, United States, 80909