The primary goal of the study is to assess the safety and performance of the Treovance device in subjects with infrarenal aortic aneurysms, specifically to evaluate if the diseased pathology can be treated with an acceptable adverse event rate and that the device performs as expected. The results of this study will permit the establishment of endpoints and clinical design for a subsequent U.S. trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Stent-graft implant
University of Massachusetts
Worcester, Massachusetts, United States
Spectrum Health System
Grand Rapids, Michigan, United States
Carolinas Sanger Heart and Vascular
Charlotte, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
major morbidity and mortality
Time frame: 1, 6, 12 months
Device performance
Rateof delivery/deployment success will be recorded. Rates of endoleak, patency, migration will be documented a 1, 6, 12 months
Time frame: implant, 1, 6, and 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sentara Heart Hospital
Norfolk, Virginia, United States