Clinical trial NCT05965453: Evaluation of the Castor Single Branch Stent Graft in Treatment of Acute Aortic Syndrome
Official title: Real-world Experience With the Castor Single Branch Stent Graft in the Management of Acute Aortic Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Aortic Syndrome
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Hanzhong Central Hospital
name: Affiliated Hospital of Gansu Medical College
name: The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
name: Xianyang Hospital of Yan'an University
name: Baoji Central Hospital
name: General Hospital of Ningxia Medical University
name: People's Hospital of Ningxia Hui Autonomous Region
name: Qinghai Red Cross Hospital
name: Hanzhong People's Hospital
First posted: 2023-07-28
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

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

Primary outcomes:
measure: Immediate post-operative technique success
timeFrame: immediately post operation
measure: All-cause mortality and major
timeFrame: 1-year post operation
Secondary outcomes:
measure: Major device/procedure-related adverse events of post-operation as assessed by computer tomography angiography
timeFrame: 1-month, 6-months, 1-year, and annually to 10-years post operation
measure: 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)
timeFrame: 1-month, 6-months, 1-year, and annually to 10-years post operation
measure: Re-intervention during follow-up
timeFrame: 1-month, 6-months, 1-year, and annually to 10-years post operation
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Hongyan Tian, MD
role: STUDY_CHAIR
References: