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.
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.
Study Type
OBSERVATIONAL
Enrollment
150
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.
Hospital Universitaire de Bordeaux
Bordeaux, France
Hopital Prive Paul d'Egine
Champigny-sur-Marne, France
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)
Time frame: Within 30-days post-procedure
Number of Participants With Major Adverse Events Through 5 Years Post-Procedure
MAE rate through 5 year includes Death, Stroke/CVA, Myocardial Infarction, New onset renal failure (requiring dialysis)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Assessed at 1 year
Number of Participants With Absence of Stent Graft Fracture Within 30-days and 1-year Post-procedure
Time frame: Assessed within 30-days and 1-year post-procedure
Absence of Aneurysm Sac Rupture
Time frame: Within 1-year post-procedure
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Augusta Krankenhaus
Düsseldorf, Germany
University Hospital Schleswig - Holstein
Kiel, Germany
University Medical Center Leipzig
Leipzig, Germany
Universitätsklinikum Münster
Münster, Germany
St.-Franziskus-Hospital
Münster, Germany
Universitätsklinikum Würzburg
Würzburg, Germany
Galway Clinic
Galway, Ireland
University Hospital Galway
Galway, Ireland
...and 13 more locations
Duration of INCRAFT® Procedure (Minutes)
Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
Time frame: Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
Amount of Time Fluoroscopy is Used During the Procedure
Time frame: Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
Amount of Contrast Volume Used During the Procedure
Time frame: Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography