Brief Title
Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms
Official Title
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
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
major morbidity and mortality
Secondary Outcome
Device performance
Condition
Abdominal Aortic Aneurysms
Intervention
Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System
Study Arms / Comparison Groups
Treovance
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
30
Start Date
June 2011
Completion Date
June 2017
Primary Completion Date
April 2013
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
Gender
All
Ages
18 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01328197
Organization ID
IP-0006-10
Responsible Party
Sponsor
Study Sponsor
Bolton Medical
Study Sponsor
, ,
Verification Date
December 2017