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

Acute Aortic Syndrome Clinical Trial

— ECAAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05965453
• Other study ID #: No.XJTU1AF2023LSK-148
• Status: Recruiting
• Start date: June 1, 2018
• Est. completion date: June 1, 2032

Study information

• Verified date: June 2023
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Hongyan Tian, MD
• Phone: 0086-13891981101
• Email: tianhongyan2020[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 205
• Est. completion date: June 1, 2032
• Est. primary completion date: June 1, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Aortic Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (10)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Affiliated Hospital of Gansu Medical College, Baoji Central Hospital, General Hospital of Ningxia Medical University, Hanzhong Central Hospital, Hanzhong People's Hospital, People's Hospital of Ningxia Hui Autonomous Region, Qinghai Red Cross Hospital, The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang Hospital of Yan'an University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	All-cause mortality and major	All-cause mortality includes aortic mortality, non-aortic mortality, and mortality from unknown causes.	1-year post operation
Secondary	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
Secondary	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
Secondary	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