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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-95
SponsorFirst Affiliated Hospital Xi'an Jiaotong University

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • 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.

Treatment groups

205 Participants
are divided into 1 treatment group
Group A: Participants received thoracic endovascular aortic repair with Castor single branch stent graft1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
immediately post operation
2

All-cause mortality and major

All-cause mortality includes aortic mortality, non-aortic mortality, and mortality from unknown causes.

Time frame
1-year post operation

Secondary outcomes

1

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.

Time frame
1-month, 6-months, 1-year, and annually to 10-years post operation
2

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

Time frame
1-month, 6-months, 1-year, and annually to 10-years post operation
3

Re-intervention during follow-up

Re-intervention result from device/procedure-related adverse events.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital Xi'an Jiaotong University

Lead sponsor

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