Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms

Status:	Completed
Conditions:	Cardiology, Cardiology, Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - 85
Updated:	12/22/2017
Start Date:	June 2011
End Date:	June 2017

A Phase I Clinical Study of the Safety and Performance of the Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms

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.

Inclusion Criteria:

- Subjects with diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or
without iliac artery involvement

- Subjects with an infrarenal AAA that is >/= 4.5 cm in diameter for males, or >/= 4.0
cm in diameter for females, or has increased in diameter by 0.5 cm in the last 6
months

- Subjects who consent to participate

- Subjects who agree to comply with the follow-up schedule

Exclusion Criteria:

- Subjects with dissections, ruptured aneurysms, or symptomatic aneurysms

- Subjects with prior AAA repair

- Subjects with medical conditions that would complicate the endovascular procedure or
confound results (e.g., Marfan's syndrome, morbid obesity, severe coronary artery
disease)

- Subjects who are pregnant or lactating

- Subjects participating in other investigational studies

- Subjects with less than 2 years life expectancy

We found this trial at

sites

Carolinas Sanger Heart and Vascular

Charlotte, North Carolina 28203

from

Charlotte, NC