Thoracic Aortic Aneurysm
Conditions
Keywords
TAA, Thoracic, Descending Thoracic Aorta, TAArget
Brief summary
Evaluate the safety and effectiveness of endovascular repair with the LeMaitre TAArget thoracic stent graft as an alternative to open surgical repair.
Detailed description
* 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.
Interventions
DEVICEEndovascular repair of TAA in the descending Thoracic Aorta
Usage of the TAArget thoracic stent graft for treatment of TAA in the Descending Thoracic Aorta.
Sponsors
Duke Vascular, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is \> 18 years of age. Female subjects are either documented post-menopausal, surgically incapable of bearing children, or for women of childbearing potential, using barrier contraceptive methods and 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: 1. Is diagnosed with a Fusiform Focal TAA ≥5cm, or 2. Is diagnosed with a Fusiform Focal TAA that has a diameter ≤ 5 cm and has exhibited rapid expansion, or 3. 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 4. Is diagnosed with a saccular TAA of any size (where potential for rupture is increased\*). * Tortuosity and angulation do not exceed 90 degrees. * Subject has an arterial access site that allows for the introduction of the stent-graft delivery system.
Exclusion criteria
* Subject has a life expectancy \< 2 years. * Subject has a lesion that prevents safe delivery or expansion of the device. * Subject has concomitant ascending aortic aneurysm. * Subject has known allergies to any of the device materials. * Subject has coagulopathy or bleeding disorders that cannot be pre-treated. * Subject is contraindicated for contrast medium and anticoagulation drugs that cannot be pre-treated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 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 | 30 day and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| • All cause mortality • Aneurysm related mortality compared to an open surgical control group • Major adverse events • Minor adverse events | 30 day and 6 month |
Countries
United States
Outcome results
None listed