Evaluation of the Castor Single Branch Stent Graft in Treatment of Acute Aortic Syndrome

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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Real-world Experience With the Castor Single Branch Stent Graft in the Management of Acute Aortic Syndrome

Conditions
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Acute Aortic Syndrome

Intervention / Treatment
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* Device: the Castor single branch stent graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants received thoracic endovascular aortic repair with Castor single branch stent graft<br>Participants who have an inadequate proximal landing zone received thoracic endovascular aortic repair by meant of the Castor single branch stent graft | Device: the Castor single branch stent graft<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | immediately post operation | 
| All-cause mortality and major | All-cause mortality includes aortic mortality, non-aortic mortality, and mortality from unknown causes. | 1-year post operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | 1-month, 6-months, 1-year, and annually to 10-years post operation |