A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With AAA (INNOVATION)

Not Applicable

Completed

Conditions: Abdominal Aortic Aneurysms

Interventions: Device: Cordis AAA stent graft system "INCRAFT TM"

Registration Number: NCT01106391

Lead Sponsor: Cordis Corporation

Brief Summary: 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.

Detailed Description: 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AAA stent graft system	Cordis AAA stent graft system "INCRAFT TM"	Cordis AAA stent graft system "INCRAFT TM"

Primary Outcome Measures

Name	Time	Method
Rate of Technical Success Through the One Month Follow up.	From procedure to 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.
Rate of Primary Safety Endpoint Within 1 Month Post-procedure.	One month follow-up	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.

Secondary Outcome Measures

Name	Time	Method
The Percentage of Participants With Stent Graft Explant at 30 Days and Annually Through 5 Years Post - Procedure.	From day 1 through year 5 post-procedure	The percentage of Stent Graft Explant at hospital discharge at 30 days and annually through 5 years post - procedure.
The Cumulative Percentage of Participants With Major Adverse Events at Annually Through 5 Years Post - Procedure.	From day 1 through year 5 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
The Percentage of Participants With Endoleg Patency at 30 Days and Annually Through 5 Years Post - Procedure.	From day 1 through year 5 post-procedure	The percentage of participants with Endoleg Patency by CT scan at 30 days and annually through 5 years post - procedure.
Percentage of Participants With Incidence of Stent-graft Migration Annually Through 5 Years Post - Procedure.	Day 30 through year 5 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.
The Percentage of Participants With Thrombosis at 30 Days and Annually Through 5 Years Post - Procedure.	From day 1 through year 5 post-procedure	The percentage of Thrombosis at hospital discharge at 30 days and annually through 5 years post - procedure.
Percentage of Participants With Incidence of Aneurysm Enlargement Annually Through 5 Years Post - Procedure.	Day 30 through year 5 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.
The Percentage of Participants With Endoleaks at Annually Through 5 Years Post - Procedure.	From day 1 through year 5 post-procedure	The percentage of endoleaks at annually through 5 years post - procedure. Endoleak contains Types I and III endoleaks
The Percentage of Participants With Stent-graft Fractures at 30 Days and Annually Through 5 Years Post - Procedure.	From day 1 through year 5 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