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NCT Number: NCT05965453

Evaluation of the Castor Single Branch Stent Graft in Treatment 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)

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Key information

Conditions

Acute Aortic Syndrome Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location status: Recruiting

Location contact

Hongyan Tian

CONTACT

[email protected]

0086-13891981101

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Immediate post-operative technique success

    Time frame: immediately post operation

    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.

  2. All-cause mortality and major

    Time frame: 1-year post operation

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

Secondary outcomes

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

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

    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.

  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)

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

    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

  3. Re-intervention during follow-up

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Hongyan Tian, MD

CONTACT

[email protected]

0086-13891981101

Mengyang Kang, MD

CONTACT

[email protected]

0086-18717366324

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: ECAAS

Important dates

Study start
2018
Primary completion
2032
Study completion
2032
First posted
Jul 28, 2023
Registry last updated
Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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