Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms
Completed · Phase 1
Conditions studied: Abdominal Aortic Aneurysms
In brief
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.
Key facts
- Study ID
- NCT01328197
- Run by
- Bolton Medical
- People needed
- 30
- Starts
- 2011-06-01
- Expected to finish
- 2017-06-01
- Last updated by the study team
- 2017-12-20
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Sentara Heart Hospital — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
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