Evaluation of the Castor Single Branch Stent Graft in Treatment of Acute Aortic Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: the Castor single branch stent graft.
- Who it may be relevant to
- Registry conditions: Acute Aortic Syndrome. Basic parameters: 18 years — 95 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Real-world Experience With the Castor Single Branch Stent Graft in the Management of Acute Aortic Syndrome
Overview
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
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.
Interventions
- Device the Castor single branch stent graft
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.
Primary outcome measures
- Immediate post-operative technique success [Time frame: immediately post operation]
- All-cause mortality and major [Time frame: 1-year post operation]
Secondary outcome measures (3)
- Major device/procedure-related adverse events of post-operation as assessed by computer tomography angiography [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) [Time frame: 1-month, 6-months, 1-year, and annually to 10-years post operation]
- Re-intervention during follow-up [Time frame: 1-month, 6-months, 1-year, and annually to 10-years post operation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- First Affiliated Hospital of Xi'an Jiaotong University — Xi'an
Identifiers
NCT: NCT05965453 · No.XJTU1AF2023LSK-148