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).
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. Upon completion of enrollment of150 subjects, an additional 50 subjects may be treated with the Treovance Stent-Graft at the 30 investigative sites participating in the trial. These additional subjects will follow the same study schedule, and data from these patients may be used to supplement the pivotal trial data. 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. Subjects with fracture(s) confirmed by the Core Lab within the first 5 years will be followed for an additional 5 years, for a total of 10 years post-implantation. 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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
158
Eligible subjects will be implanted with the Treovance Stent-Graft
Primary Efficacy
Successful aneurysm treatment which is a composite of the following: Technical success at the conclusion of the procedure; absence of aneurysm enlargement; absence of device-related complications (e.g., fracture, conversion to open surgical repair, etc.)
Time frame: 12 months
Primary Safety
The primary safety endpoint is composite major adverse event (MAE) rate (including myocardial infarction, stroke, respiratory failure, etc.)
Time frame: 30 days
Secondary Efficancy Endpoint -- Aneurysm-Related Mortality
Aneurysm-related mortality at 12 month and annually to 5 years; annually to 10 years for subjects with Core Lab-confirmed fracture(s)
Time frame: Annually to 5-years; annually to 10-years (stent-fracture subjects only)
Secondary Efficacy Endpoint -- Technical Success
Technical success at 30 days confirmed by an imaging modality (e.g. CT)
Time frame: 30 days
Secondary Efficacy Endpoint -- Clinical Utility Measures
Clinical utility measures (procedure time, time in the intensive care unit, length of hospital stay)
Time frame: Perioperative/Periprocedural
Secondary Efficacy Endpoint -- Secondary interventions
The secondary efficacy endpoint includes the rate of additional procedures performed to correct the original implant
Time frame: 30 days, 6 months, annually to 5-years; annually to 10-years (stent-fracture subjects only)
Secondary Efficacy Endpoint -- Device-Related Events
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University of Alabama-Birmingham
Birmingham, Alabama, United States
Arizona Heart Institute
Phoenix, Arizona, United States
Danbury Hospital
Danbury, Connecticut, United States
Lynn Heart and Vascular Institute
Boca Raton, Florida, United States
Northside Hospital Heart & Vascular Institute
Atlanta, Georgia, United States
Presence Medical Center -- Christie Clinic
Champaign, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Affiliated Surgeons of Rockford Memorial Hospital
Rockford, Illinois, United States
University of Iowa Hospital and Clinic
Iowa City, Iowa, United States
Tufts University Medical Center
Boston, Massachusetts, United States
...and 19 more locations
This endpoint includes the rate of events associated with the device.
Time frame: 30 days, 6 months, and annually to 5-years; annually to 10-years (stent-fracture subjects only)
Secondary Safety Endpoint -- Individual Rate for Events included in the composite MAE
Secondary safety endpoints will include each individual rate for the adverse events included in the composite MAE at 30 days, 6 months, and annually to 5 years
Time frame: 30 days, 6 months, annually to 5 years
Secondary Safety Endpoint -- Procedure-Related Complications
Procedure-related complications at 30 days, 6 months, 12 months, and annually to 5 years.
Time frame: 30 days, 6 months, annually to 5 years