NCT01328197
Completed
Phase 1
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
Bolton Medical6 sites in 1 country30 target enrollmentJune 2011
ConditionsAbdominal Aortic Aneurysms
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Abdominal Aortic Aneurysms
- Sponsor
- Bolton Medical
- Enrollment
- 30
- Locations
- 6
- Primary Endpoint
- major morbidity and mortality
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
major morbidity and mortality
Time Frame: 1, 6, 12 months
Secondary Outcomes
- Device performance(implant, 1, 6, and 12 months)
Study Sites (6)
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