Prospective, multicenter, Single Arm Safety and Effectiveness Confirmatory Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellis System
This Study is
No Longer Enrolling
Patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair and who meet the study eligibility criteria may be screened for enrollment in the study
Adult
□ Have an infrarenal abdomincal aortic aneurysm (AAA) with maximum sac diameter ≥ 5.0cm, or ≥ 4.5 cm which has increased by ≥0.5cm within the last 6 months, or which exceeds 1.5 times the tranverse dimension of an adjacent non-aneurysmal aortic segment. No AAA <4 cm will be included. □ Anatomic eligibility for the Nellix System per the instructions for use □ No CVA or MI within three months of enrollment/treatment
Not Applicable - Describes studies without FDA-defined phases, including studies of devices or behavioral interventions.
Treatment
Memorial Hospital Central
Protocol Number: 19-6501
More information available at ClinicalTrials.gov: NCT03298477
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