This study was a prospective observational study examined the safety of the TriVascular AAA Stent-Graft System in the elective treatment of patients with abdominal aortic aneurysms. Specifically, the study will evaluate the safety of the TriVascualr AAA Stent-Graft System, evaluate the ability to deliver the Tri-Vascular AAA Stent-Graft System to the desired location within the aorta, and evaluate the ability of the TriVascular AAA Stent-Graft to exclude the abdominal aortic aneurysm.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
TriVascular Stent-Graft System
Harbor UCLA Medical Center
Torrance, California, United States
Georgetown University Pasquerilla Healthcare
Washington D.C., District of Columbia, United States
University of Florida - Shands Hospital
Gainesville, Florida, United States
Miami Cardiac & Vascular Institute Baptist Hospital
Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure.
Device related adverse events included, but were not limited to: Stent Graft Migration, Vessel dissection or perforation, stent graft occlusion, branch vessel occlusion, aneurysm rupture.
Time frame: 1 month
Number of Participants Without a Type I, III, and/or IV Endoleak at 1 Month Follow-up Identified by Computed Tomography (CT).
A Type I endoleak is a persistent perigraft channel of blood flow that develops due to inadequate or ineffective seal at the graft ends (attachment zones). A Type III endoleak occurs in the midgraft region due to leakage through a defect in the graft fabric or between the segments of a multisegmental graft. A Type IV endoleak is seen on completion of angiography or subsequent contrast studies as any blush of contrast that is presumed to emanate from blood diffusion across the porous graft fabric or through small holes in the graft cause by sutures or stent struts.
Time frame: 1 month
Number of Participants Who Achieve Technical Success of the Stent Graft System.
Technical success was defined as successful introduction of the delivery catheter into the arterial system at the time of the study procedure and successful delivery/deployment of the stent graft system to the intended location with the absence of device related surgical conversion and intra-operative mortality. Device related surgical conversion is defined as the inability to deliver or deploy the stent graft system, then subsequently surgically treating the patient.
Time frame: Post procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Miami, Florida, United States
Albany Medical College
Albany, New York, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Shadyside Hospital
Pittsburgh, Pennsylvania, United States