The sudy purpose is to investigate efficacy and safety of percutaneous endovascular aortic aneurysm repair using INCRAFT stent graft for Korean patients with abdominal aortic aneurysm. This study is designed as an investigator-initiated, multi-center, single-arm, prospective registry study. A total of 100 patients who meet all inclusion criteria, but none of exclusion criteria will be enrolled after the implantation of INCRAFT stent graft. The primary efficacy outcome is technical success defined as successful deployment of the stent-graft with no type I/III endoleak, unintentional coverage of visceral aortic branches or internal iliac arteries at the end of the procedure, and with successful removal of the delivery system. The primary safety outcome is major vascular complications at 30 days including. The study subjects will be followed for 12 months.
Prospective single-arm multicenter registry
Study Type
OBSERVATIONAL
Enrollment
86
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, 50 Yonsei-ro, Seodaemun-gu
Seoul, South Korea
Technical success
Technical success defined as successful deployment of the stent-graft with no type I/III endoleak, unintentional coverage of visceral aortic branches or internal iliac arteries at the end of the procedure, and with successful removal of the delivery system. Primary conversion or additional implantation of bare metal stent, aortic cuff or EndoAnchors to treat type I endoleak is considered a technical failure.
Time frame: At the end of the procedure
Major adverse event
Major adverse event, a composite of death, myocardial infarction, stroke, or renal failure requiring dialysis) at 30 days
Time frame: 30 days
Major adverse event
Major adverse event, a composite of death, myocardial infarction, stroke, or renal failure requiring dialysis) at 1 year
Time frame: 1 year
Aneurysm-related death
All-cause death at 30 days
Time frame: 30 days
Aneurysm-related death
All-cause death at 1 year
Time frame: 1 year
Aneurysm-related death
Aneurysm-related death at 30 days
Time frame: 30 days
Aneurysm-related death
Aneurysm-related death at 1 year
Time frame: 1 year
Reintervention
Reintervention at 1 year
Time frame: 1 year
Type I/III endoleaks
Type I/III endoleaks at 30 days
Time frame: 30 days
Type I/III endoleaks
Type I/III endoleaks at 1 year
Time frame: 1 year
Aneurysm-related event
Aneurysm-related event (aneurysm-related death, reintervention, and aorta expansion\> 5 mm, device migration, conversion to open repair, stent graft fracture, stent graft occlusion) at 1 year
Time frame: 1 year
All vascular complications related to the INCRAFT device or aneurysm requiring surgical or endovascular interventions
All vascular complications at 30 days related to the INCRAFT device or aneurysm requiring surgical or endovascular interventions
Time frame: 30 days
Number of closure devices used for the closure of access sites.
Number of closure devices used for the closure of access sites.
Time frame: 30 days
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