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

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

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)

Study Overview

• Status: Recruiting
• Conditions: Acute Aortic Syndrome
• Intervention / Treatment: Device: the Castor single branch stent graft

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.

• Study Type: Observational
• Enrollment (Estimated): 205

Contacts and Locations

• Study Contact: Name: Hongyan Tian, MD; Phone Number: 0086-13891981101; Email: tianhongyan2020@163.com
• Study Contact Backup: Name: Mengyang Kang, MD; Phone Number: 0086-18717366324; Email: kmy9610@stu.xjtu.edu.cn

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • First Affiliated Hospital of Xi'an JiaoTong University
      • Contact: Hongyan Tian; Phone Number: 0086-13891981101; Email: tianhongyan2020@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants received thoracic endovascular aortic repair with Castor single branch stent graft; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: General Hospital of Ningxia Medical University; Baoji Central Hospital; Qinghai Red Cross Hospital; Hanzhong Central Hospital; People's Hospital of Ningxia Hui Autonomous Region; Xianyang Hospital of Yan'an University; Hanzhong People's Hospital; Affiliated Hospital of Gansu Medical College; The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
• Investigators: Study Chair: Hongyan Tian, MD, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Estimated): June 1, 2032
• Study Completion (Estimated): June 1, 2032

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease; Aortic Diseases; Syndrome; Acute Aortic Syndrome
• Other Study ID Numbers: No.XJTU1AF2023LSK-148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No