The objective of this study to evaluate the safety and effectiveness of the Castor single branch stent graft for endovascular repair of acute aortic syndrome patients without an inadequate proximal landing zone (\<15mm)
The goal of this observational, ambispective, and multicenter cohort study is to evaluate efficacy and safety of the Castor single branch stent graft. 205 patients who received thoracic endovascular aortic repair by meant of the Castor single branch stent graft from June 2018 to June 2022 were enrolled in our study. All enrolled patients have an inadequate proximal landing zone (\<15mm) , and they underwent routine follow-up after thoracic endovascular aortic repair at 1-month, 6-months, and 1-year for the following, but not limited to assessment: physical examination, laboratory test and the CT angiography. Meanwhile, the enrolled patients will come for continuous follow-up at 2-years, 3-years, and annually to 10-years post-procedure.
Study Type
OBSERVATIONAL
Enrollment
205
Participants who received thoracic endovascular aortic repair by meant of the Castor single branch stent graft from June 2018 to June 2022 were enrolled in our study.
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
RECRUITINGImmediate post-operative technique success
Immediate technical success is defined as successful delivery of the aortic and branching stent graft conveyors to their predetermined position, accurate positioning and successful deployment of the stent, safe removal of the delivery device outside the body, absence of Type I and III endoleaks on angiography at the end of the procedure, and patent branch stents.
Time frame: immediately post operation
All-cause mortality and major
All-cause mortality includes aortic mortality, non-aortic mortality, and mortality from unknown causes.
Time frame: 1-year post operation
Major device/procedure-related adverse events of post-operation as assessed by computer tomography angiography
Major device or procedure related major adverse events as assessed by computer tomography angiography included: death, dissection or aneurysm rupture, new myocardial infarction requiring intervention (percutaneous transluminal coronary angioplasty, bypass), retrograde type A aortic dissection, endoleaks, new disabling stroke, paraplegia, new hepatic infarction, new chronic renal insufficiency/renal failure requiring dialysis, lower limb ischemia (increase in Rutherford classification), access vessel thrombosis or rupture, conversion to open surgery, and stent migration, fracture or migration, stent graft infection, stent graft-induced new entry tear.
Time frame: 1-month, 6-months, 1-year, and annually to 10-years post operation
Aortic remodeling results as assessed by computer tomography angiography (the size of the true and false lumen of aorta, and the thrombosis degree of the false lumen of aorta)
Compare the results of computer tomography angiography before operation and on the first-, 6th- and 12th-month post operation, the expansion of the true lumen and the thrombosis of the false lumen at the coverage of the stent graft to determine whether the blood vessel is successfully remodeled
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Time frame: 1-month, 6-months, 1-year, and annually to 10-years post operation
Re-intervention during follow-up
Re-intervention result from device/procedure-related adverse events.
Time frame: 1-month, 6-months, 1-year, and annually to 10-years post operation