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

NCT05965453 | Recruiting

• 1 other identifier: No.XJTU1AF2023LSK-148
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 1

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)

Conditions

Acute Aortic Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Major device/procedure-related adverse events of post-operation as assessed by computer tomography angiography

  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)

  1-month, 6-months, 1-year, and annually to 10-years post operation

• Re-intervention during follow-up

  1-month, 6-months, 1-year, and annually to 10-years post operation

Study Arms (1)

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

Interventions

the Castor single branch stent graft DEVICE

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.

Participants received thoracic endovascular aortic repair with Castor single branch stent graft

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Acute Aortic Syndrome

Condition Hierarchy (Ancestors)

Aortic Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hongyan Tian, MD

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Central Study Contacts

Hongyan Tian, MD

CONTACT

0086-13891981101; tianhongyan2020@163.com

Mengyang Kang, MD

CONTACT

0086-18717366324; kmy9610@stu.xjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 28, 2023
• Study Start: June 1, 2018
• Primary Completion (Estimated): June 1, 2032
• Study Completion (Estimated): June 1, 2032
• Last Updated: July 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)