Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, 50 Yonsei-ro, Seodaemun-gu
Seoul, South Korea
NCT Number: NCT03952780
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.
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Notify Me19 year–80 year
All sexes
Observational
Seoul, South Korea
Prospective single-arm multicenter registry
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At the end of the procedure
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: 30 days
Major adverse event, a composite of death, myocardial infarction, stroke, or renal failure requiring dialysis) at 30 days
Time frame: 1 year
Major adverse event, a composite of death, myocardial infarction, stroke, or renal failure requiring dialysis) at 1 year
Time frame: 30 days
All-cause death at 30 days
Time frame: 1 year
All-cause death at 1 year
Time frame: 30 days
Aneurysm-related death at 30 days
Time frame: 1 year
Aneurysm-related death at 1 year
Time frame: 1 year
Reintervention at 1 year
Time frame: 30 days
Type I/III endoleaks at 30 days
Time frame: 1 year
Type I/III endoleaks at 1 year
Time frame: 1 year
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: 30 days
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.
Yonsei University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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