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.
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
6
sites
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
Click here to add this to my saved trials
Click here to add this to my saved trials