European (EU) Post Approval Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms

Study Overview
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Brief Summary
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INSIGHT is a postmarket clinical follow-up study in the European Union. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of INCRAFT in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 150 subjects will be enrolled and followed through 5-years post procedure. Up to 25 sites in Europe may participate.

Detailed Description
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INSIGHT is a postmarket clinical follow-up study in the European Union. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of INCRAFT in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 150 subjects will be enrolled and followed through 5-years postprocedure. Up to 25 sites in Europe may participate. Subjects will be enrolled and followed at 1 month and 6 month post-procedure and annually up to 5 years.

Official Title
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A Multicenter, Open Label, Prospective, Post Approval Study of the INCRAFT® Abdominal Aortic Aneurysm (AAA) Stent Graft System in Subjects With Abdominal Aortic Aneurysms

Conditions
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Abdominal Aortic Aneurysms

Intervention / Treatment
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* Device: Endovascular abdominal aortic aneurysm repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female age 18 years or older Femoral access vessels should be adequate to fit the selected delivery system Proximal neck length ≥ 10mm Aortic neck diameters ≥ 17mm and ≤ 31mm Aortic neck suitable for suprarenal fixation Infrarenal and suprarenal neck angulation ≤ 60° Iliac fixation length ≥ 15mm Iliac diameters ≥ 7mm and ≤ 22mm Minimum overall AAA treatment length (proximal landing location to distal landing location) ≥ 128mm Morphology suitable for aneurysm repair Provide written informed consent and as applicable written confidentiality authorization prior to initiation of study procedures Subject is willing to comply with the specified follow-up evaluation schedule Exclusion Criteria: Subject has one of the following: Aneurysm sac rupture or leaking abdominal aortic aneurysm Mycotic, dissecting, or inflammatory abdominal aortic aneurysm Known allergy or intolerance to nickel titanium (nitinol), Polyethylene terephthalate (PET), or polytetrafluoroethylene (PTFE) Known contraindication to undergoing angiography or anticoagulation Existing AAA surgical graft and/or a AAA stent-graft system Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Endovascular abdominal aortic aneurysm repair|Subjects with infrarenal abdominal aortic aneurysms who meet all inclusion criteria and none of the exclusion criteria will be treated with the INCRAFT Stent Graft System.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Major Adverse Events (MAE) Through 30 Days | MAE rate through 30 days includes Death, Stroke/CVA, Myocardial Infarction, New onset renal failure (requiring dialysis) | Within 30-days post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of Major Adverse Events |  | Through 5 years post-procedure | 
| Number of Participants With Technical Success at Conclusion of Index Procedure | successful insertion of the delivery system through the vasculature and successful deployment of the device at the intended location | At the conclusion of the index procedure | 
| Absence of Type I or III Endoleak | defined as absence of type I or III endoleaks and absence of aneurysm enlargement (growth >5mm compared to the 1-month size measurement) within 1-year post-procedure as assessed by the core lab | Within 1 year post-procedure | 
| InCraft® - AAA Stent Graft System | Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System | Assessed at 1 year | 
| Number of Participants With Absence of Stent Graft Fracture Within 30-days and 1-year Post-procedure |  | Assessed within 30-days and 1-year post-procedure | 
| Absence of Aneurysm Sac Rupture |  | Within 1-year post-procedure | 
| Duration of INCRAFT® Procedure (Minutes) | Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography | Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography | 
| Amount of Time Fluoroscopy is Used During the Procedure |  | Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography | 
| Amount of Contrast Volume Used During the Procedure |  | Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endovascular repair