This study is a multi-center prospective, open label, non-randomized investigation of INCRAFT™ in subjects with abdominal aortic aneurysms. The study will enroll up to 60 subjects in up to 7 sites in Germany and Italy.
This study is a multi-center prospective, open label, non-randomized investigation of INCRAFT™ in subjects with abdominal aortic aneurysms. The study will enroll up to 60 subjects at 7 sites in Germany and Italy. All treated subjects will be evaluated at 1 month, 3 months (if applicable), 6 and 12 months, and annually for a total of 5 years post-procedure. An interim analysis will be conducted after the 25th enrolled subject reaches the 30-day follow up visit
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Universitat Leipzig Herzzentrum
Leipzig, Germany
Rate of Technical Success Through the One Month Follow up.
Technical success is defined as the successful deployment of the stent-graft to the desired location in the absence of Types I, III or IV endoleaks at the conclusion of the procedure and through the one month follow up.
Time frame: From procedure to one month follow up
Rate of Primary Safety Endpoint Within 1 Month Post-procedure.
Primary safety is defined by the absence of Types I, III or IV endoleaks and device and/or procedural related major adverse events within 1 month post-procedure. Major adverse events include death, MI, stroke and renal failure.
Time frame: One month follow-up
Percentage of Participants With Incidence of Aneurysm Enlargement Annually Through 5 Years Post - Procedure.
Incidence of aneurysm enlargement annually through 5 years post - procedure. Aneurysm enlargement is defined as being compared to the 30 day baseline assessment.
Time frame: Day 30 through year 5 post-procedure
Percentage of Participants With Incidence of Stent-graft Migration Annually Through 5 Years Post - Procedure.
Incidence of Stent-graft Migration annually through 5 years post - procedure. Stent-graft Migration is defined as being compared to the 30 day baseline assessment.
Time frame: Day 30 through year 5 post-procedure
The Cumulative Percentage of Participants With Major Adverse Events at Annually Through 5 Years Post - Procedure.
The cumulative percentage of participants with Major Adverse Events (MAE) at annually through 5 years post - procedure; i.e., the percentage of MAE at Year 1 includes all MAEs occurred during the first year, the percentage at Year 2 includes all MAEs during the first two years, and etc. The Major adverse events include death, stroke, Q wave myocardial infarction, and renal failure
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Time frame: From day 1 through year 5 post-procedure
The Percentage of Participants With Endoleaks at Annually Through 5 Years Post - Procedure.
The percentage of endoleaks at annually through 5 years post - procedure. Endoleak contains Types I and III endoleaks
Time frame: From day 1 through year 5 post-procedure
The Percentage of Participants With Stent-graft Fractures at 30 Days and Annually Through 5 Years Post - Procedure.
The percentage of stent-graft fracture at 30 days and annually through 5 years post - procedure. Stent-graft fracture is defined as stent skeleton fracture and barb separation
Time frame: From day 1 through year 5 post-procedure
The Percentage of Participants With Thrombosis at 30 Days and Annually Through 5 Years Post - Procedure.
The percentage of Thrombosis at hospital discharge at 30 days and annually through 5 years post - procedure.
Time frame: From day 1 through year 5 post-procedure
The Percentage of Participants With Stent Graft Explant at 30 Days and Annually Through 5 Years Post - Procedure.
The percentage of Stent Graft Explant at hospital discharge at 30 days and annually through 5 years post - procedure.
Time frame: From day 1 through year 5 post-procedure
The Percentage of Participants With Endoleg Patency at 30 Days and Annually Through 5 Years Post - Procedure.
The percentage of participants with Endoleg Patency by CT scan at 30 days and annually through 5 years post - procedure.
Time frame: From day 1 through year 5 post-procedure