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

Study Overview
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Brief Summary
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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
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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

Official Title
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A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With Abdominal Aortic Aneurysms

Conditions
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Abdominal Aortic Aneurysms

Intervention / Treatment
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* Device: Cordis AAA stent graft system INCRAFT TM


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: Subject is a male or infertile female > 18 years of age Subject understands study requirements and treatment procedures and agrees to sign an informed consent form prior to any study procedures. Subject is considered an appropriate candidate for open surgical repair of an abdominal aortic aneurysm. Subject has at least one of the following: Abdominal aortic aneurysm ≥4.5 cm in women or ≥ 5 cm in men in diameter Aneurysm, which is >4 cm and which has increased in size by 0.5 cm within 6 months The maximum aortic diameter is ≥1.5 times that of the reference aortic diameter Saccular aneurysm Subject has access vessel size compatible with vascular access techniques and potential accessories used with delivery profile of 14Fr Subject aortic aneurysm neck is ≥15 mm in length Subject iliac landing zone≥10mm in length Subject has distal iliac landing sites with diameter ranges of 9-18mm Subject proximal aortic attachment is between 20-27 mm in diameter. Subject has a minimum overall AAA treatment length (from lowest renal artery to distal landing zone) of 140 mm. Subject is willing to comply with all specified follow-up evaluations. EXCLUSION CRITERIA: Subject has one of the following: a dissecting or inflammatory aneurysm acutely ruptured aneurysm pararenal or leaking aneurysm The supra-renal aorta at 2cm above the lowest renal aorta is not more than the nominal diameter of the aortic bifurcate prosthesis Aortic length (lowest renal artery origin to the aortic bifurcation) of <8.7 cm Circumferential thrombosis and/or calcification ≥50% in the aortic and iliac landing zones Circumferential thrombosis and/or calcification ≥50% in the supra-renal aorta Subject has aneurysm neck angulations that are >60° in the supra-renal and/or infra-renal locations Aortic bifurcation ≤18mm in diameter Acute vascular injury due to trauma Subject has a known allergy to contrast medium Subject has known allergy to nitinol, PET or PTFE Subject has a need for emergent surgery Subject has a contraindication to undergoing angiography Subject has a thoracic aortic aneurysm that requires treatment Subject has Infra-renal aortic dissection Subject has an Iliac anatomy which would require occlusion of both internal iliac arteries Subject has congenital abnormalities in which the placement of the stent-graft will cause occlusion of major arterial flow. Such abnormalities should be evaluated (e.g. angiography or CT) prior to treatment Subject has unstable angina as defined by Braunwald angina classification Subject has morbid obesity (BMI of >40.0) or other clinical conditions that severely inhibit visualization of the aorta Subject has connective tissue disease (e.g., Marfan's or Ehler's-Danos syndrome) Subject has known bleeding or hypercoagulable disorder Subject has contraindication for anticoagulation Subject with Stroke or MI or intracranial bleeding within 3 months prior to the procedure Subject with renal insufficiency (creatinine > 2.0 mg/dl) Subject has known or suspected active infection at the time of the index procedure (for ex. Pneumonia, acute virus infection, contaminated wounds etc) Subject is currently taking systemic immunosuppressant therapy Subject had a major surgical procedure within 30 days prior to procedure or planned within 30 days post procedure Subject has a life expectancy less than 2 years Subject is currently participating in another research study involving an investigational device or new drug Other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment Subject with an existing AAA surgical graft and/or a AAA stent-graft system

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AAA stent graft system<br>Cordis AAA stent graft system INCRAFT TM | Device: Cordis AAA stent graft system INCRAFT TM<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | One month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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 | 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 | 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. | 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. | 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. | From day 1 through year 5 post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal aortic aneurysm, AAA, Safety, Performance, Stent graft system, First in Human, Endovascular repair