About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with acute Stanford type B aortic syndrome who received thoracic endovascular aortic repair by meant of Castor single branch stent graft from June 2018 to June 2022
Disqualifiers
Patients with acute type B aortic syndrome with an adequate proximal landing zone (≥15mm)
Previous endovascular repair of the aorta
Patients with missing data and loss of follow-up
Trial population
All patients with acute Stanford type B aortic syndrome who received thoracic endovascular aortic repair by meant of Castor single branch stent graft in the above 10 medical centers from June 2018 to June 2022 were enrolled.
Trial design
Cohort
Other
Treatments tested in this trial
the Castor single branch stent graft
DeviceParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Immediate 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.
All-cause mortality and major
All-cause mortality includes aortic mortality, non-aortic mortality, and mortality from unknown causes.
Secondary outcomes
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.
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
Re-intervention during follow-up
Re-intervention result from device/procedure-related adverse events.
Sponsors and contacts
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First Affiliated Hospital Xi'an Jiaotong University
Lead sponsor
Hanzhong Central Hospital
Collaborator
Affiliated Hospital of Gansu Medical College
Collaborator
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Collaborator
Xianyang Hospital of Yan'an University
Collaborator
Baoji Central Hospital
Collaborator
General Hospital of Ningxia Medical University
Collaborator
People's Hospital of Ningxia Hui Autonomous Region
Collaborator
Qinghai Red Cross Hospital
Collaborator
Hanzhong People's Hospital
Collaborator