INITIATION is a postmarket clinical follow-up study in China. 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 120 subjects will be enrolled and followed through 1-years postprocedure. Up to 20 sites in China may participate.
INITIATION is a postmarket clinical follow-up study in China. 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 120 subjects will be enrolled and followed through 1-years postprocedure. Up to 20 sites in China may participate. Subjects will be enrolled and followed at 1 month and 1 year post-procedure.
Study Type
OBSERVATIONAL
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.
Beijing Anzhen Hospital
Beijing, China
Absence of major adverse events
MAE is defined as the combination of death, myocardial infarction, stroke/cerebrovascular accident, and renal failure.
Time frame: Within 30-days post-procedure
Occurence of major adverse events
MAE is defined as the combination of death, myocardial infarction, stroke/cerebrovascular accident, and renal failure.
Time frame: Through 1 year post-procedure
Technical success
The technical success at the end of the first surgery, which was defined as the successful insertion of the delivery system and the successful placement of the device at the desired location.
Time frame: At the conclusion of the index procedure
Absence of stent graft migration(>10mm)
Stent graft migration is defined as evidence of proximal or distal movement of the stent graft \> 10mm relative to fixed anatomical landmarks compared with the 1 month size measurement.
Time frame: Assessed at 1 year
Absence of Type I or Type III endoleak and no aneurysm enlargement (growth >5mm)
Endoleak is defined as a persistent blood flow outside the lumen of the endoluminal graft but within an aneurysm sac or adjacent vascular segment being treated by the device. They are the result of incomplete sealing, or exclusion of the aneurysm sac, and thus cause reflux of blood flow into the sac. Aneurysm enlargement is defined as an increase in maximum aneurysm cross sectional diameter greater than 5mm compared to a baseline measurement, or any subsequent measurement following baseline.
Time frame: Assessed at 1 year compared to size measurement at 1 month
Absence of stent graft fracture
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Stent-graft fracture is defined as stent skeleton fracture and barb separation.
Time frame: Assessed within 30-days and 1-year post-procedure
Absence of stent occlusion (including unilateral or bilateral limb occlusion) and aneurysm sac rupture
Stent occlusion is defined as a complete absence of flow, within the AAA stent graft (aortic bifurcate or one or both iliac limbs).
Time frame: Within 1-year post-procedure
Absence of all-cause mortality and aneurysms-related death
Aneurysms-related death is defined as a death from AAA rupture, or death within 30 days of open aortic surgical or endovascular repair or death from any subsequent procedure required to treat the same aneurysm.
Time frame: Within 1-year post-procedure