Acute Aortic SyndromeECAASNCT05965453
Evaluation of the Castor Single Branch Stent Graft in Treatment of Acute Aortic Syndrome
An observational study of Acute Aortic Syndrome, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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) Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Acute Aortic Syndrome
- What is being tested?
- the Castor single branch stent graft
- Type of treatment
- Medical device
- How many people
- 205 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 1 Jun 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Hongyan Tian, 0086-13891981101, tianhongyan2020@163.com
About this study
Official title: 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)
Read the 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.
- Conditions
- Acute Aortic Syndrome
- Being tested
- the Castor single branch stent graft
- Medical subject headings
- Acute Aortic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Castor single branch stent graftDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: the Castor single branch stent graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately post operation
All-cause mortality and major
All-cause mortality includes aortic mortality, non-aortic mortality, and mortality from unknown causes.
Measured: 1-year post operation
Secondary outcomes (3)
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.
Measured: 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
Measured: 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.
Measured: 1-month, 6-months, 1-year, and annually to 10-years post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Jun 2018
- Primary completion1 Jun 2032 (estimated)
- Study completion1 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Aortic SyndromeStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hanzhong Central Hospital, Affiliated Hospital of Gansu Medical College, The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang Hospital of Yan'an University, Baoji Central Hospital, General Hospital of Ningxia Medical University, People's Hospital of Ningxia Hui Autonomous Region, Qinghai Red Cross Hospital, Hanzhong People's Hospital
- Responsible party
- Sponsor
- Investigators
- Hongyan Tian, MD, Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965453
- Sponsor's protocol ID
- No.XJTU1AF2023LSK-148
- Acronym
- ECAAS
- Status last verified
- Jun 2023
- First submitted
- 27 Jun 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Experience With the Castor Single Branch Stent Graft in the Management of Acute Aortic Syndrome
- ClinicalTrials.gov ID
- NCT05965453
- Acronym / sponsor ID
- ECAAS / No.XJTU1AF2023LSK-148
- Conditions
- Acute Aortic Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Hanzhong Central Hospital, Affiliated Hospital of Gansu Medical College, The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang Hospital of Yan'an University, Baoji Central Hospital, General Hospital of Ningxia Medical University, People's Hospital of Ningxia Hui Autonomous Region, Qinghai Red Cross Hospital, Hanzhong People's Hospital
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2032 (estimated)
- Study completion
- 1 Jun 2032 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants received thoracic endovascular aortic repair with Castor single branch stent graft | – | Device: the Castor single branch stent graftParticipants who have an inadequate proximal landing zone received thoracic endovascular aortic repair by meant of the Castor single branch stent graft |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the Castor single branch stent graftParticipants 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. | Device | Participants received thoracic endovascular aortic repair with Castor single branch stent graft |
Primary outcome
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.
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.
3 secondary outcomes
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
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
Re-intervention during follow-up
Time frame: 1-month, 6-months, 1-year, and annually to 10-years post operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongyan Tian, MD study chair
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Aortic Syndrome, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongyan Tian, MD (0086-13891981101, tianhongyan2020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate post-operative technique success (time frame: immediately post operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.