Brief Title
Clinical Study of the Treovance Stent-Graft for Patients With Abdominal Aortic Aneurysms
Official Title
A Phase II 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 purpose of this clinical trial is to assess and evaluate the safety and efficacy of the
Treovance Stent-Graft with Navitel Delivery System in subjects with Abdominal Aortic
Aneurysms (AAA).
Detailed Description
This is a phase II, multi-center, non-blinded, non-randomized study of treatment with the
Treovance Stent-Graft in subjects with abdominal aortic aneurysms. The study will include 150
subjects treated with the Treovance Stent-Graft at a maximum of 30 investigational sites.
There will be no prospective control group. Subjects diagnosed with infrarenal abdominal
aortic aneurysms enrolled in the trial will be treated with the Treovance Stent-Graft with
Navitel Delivery System. Pre-procedure baseline data will be gathered, as well as
post-procedure assessments prior to hospital discharge and 30 days, 6 months, and 12 months
post-implantation. In addition, annual follow-up visits out to 5 years will be conducted.
The primary goal of this study is to gather safety and effectiveness data on the Treovance
device. A maximum of 150 endovascular subjects will be required to fulfill the U.S. Phase II
requirements. The data from this study will be submitted to the FDA and used to support
approval in the U.S.
There are two primary objectives, efficacy and safety of the Treovance Stent-Graft in
subjects with infrarenal aortic aneurysms:
- Primary Efficacy will be evaluated by successful aneurysm treatment 12 months
post-implant
- Primary Safety will be assessed by composite major adverse event (MAE) rate at 30-days
Secondary objectives involve assessment of major device-related events and major morbidity.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Primary Efficacy
Secondary Outcome
Secondary Safety Endpoint
Condition
Abdominal Aortic Aneurysm (AAA)
Intervention
Subjects who receive the Treovance stent-graft
Study Arms / Comparison Groups
Treovance
Description: Subjects who receive the Treovance stent-graft
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
150
Start Date
November 23, 2013
Completion Date
June 2025
Primary Completion Date
March 20, 2017
Eligibility Criteria
Inclusion Criteria:
- Subject must be diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or
without iliac artery involvement
- Subject must have 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
Exclusion Criteria:
- Subject has a dissection in abdominal aorta, ruptured aneurysm, or symptomatic
aneurysm (as determined by treating physician)
- Subject has had a prior AAA repair (endovascular or surgical)
- Subject is participating in another research study, has received investigational study
drug within 30 days of planned procedure, or has received an investigational device
within one year of planned procedure
Gender
All
Ages
18 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
Matthew Eagleton, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02009644
Organization ID
IP-0008-12
Responsible Party
Sponsor
Study Sponsor
Bolton Medical
Study Sponsor
Matthew Eagleton, MD, Principal Investigator, Cleveland Clinic Foundaton
Verification Date
June 2020