Evaluate the safety and effectiveness of endovascular repair with the LeMaitre TAArget thoracic stent graft as an alternative to open surgical repair.
* Subject is \> 18 years of age. * Females subjects must be either documented post-menopausal, surgically incapable of bearing children, or for women of childbearing potential, using barrier contraceptive methods and must have a negative serum pregnancy test at screening. * Subject is a candidate for endovascular thoracic aortic repair. * Subject has a TAA that meets one of the following criteria: * Is diagnosed with a Fusiform Focal TAA \>5cm, or * Is diagnosed with a Fusiform Focal TAA that has a diameter \< 5 cm and has exhibited rapid expansion, or * Is diagnosed with a Fusiform Focal TAA that has a diameter ≥ 4.5 cm and is at least twice the size of the normal DTA, or * Is diagnosed with a saccular TAA of any size.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Usage of the TAArget thoracic stent graft for treatment of TAA in the Descending Thoracic Aorta.
Christiana Hospital
Newark, Delaware, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Proportion of subjects who experience ≥ 1 major adverse events (MAE) related to the experimental device/procedure at early (30-day) and late (6-month) endovascular TAA repair as compared with the open surgical repair group.
Time frame: 30 day and 6 month
The primary effectiveness endpoint of early (30-day) and late (6-month) endovascular TAA repair will be assessed by the proportion of subjects free from major device related events
Time frame: 30 day and 6 months
• All cause mortality • Aneurysm related mortality compared to an open surgical control group • Major adverse events • Minor adverse events
Time frame: 30 day and 6 month
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