Aortic DissectionNCT05405790
Antibiotic Prophylaxis for TEVAR
An observational study of Aortic Dissection and Aortic Diseases, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
The infection rate of thoracic endovascular aortic repair (TEVAR) is unknown due to a lack of epidemiological data. The rate currently available comes from researches conducted decades ago, when open surgery was the standard of care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Dissection, Aortic Diseases, Aortic Aneurysm, Thoracic
- What is being tested?
- thoracic endovascular aortic repair
- Type of treatment
- Surgery or procedure
- How many people
- 457 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who were diagnosed with thoracic aortic dissection, thoracic aortic aneurysm, thoracic aortic intramural hematoma, or other thoracic aortic diseases and underwent TEVAR during hospitalization
Who may be able to join
- Diagnosed with thoracic aortic diseases
- Received TEVAR
Who cannot join
- Suspected infectious aortic disease, such as a mycotic aneurysm.
- TEVAR combined with open surgery
- Antibiotics have been used more than 24 hours before the operation
- Combined with immune deficiency disease or using hormone or immunosuppressant；
- The treatment is for the complications of TEVAR, such as endoleak
- Endovascular aortic repair for abdominal aortic disease
- History of open aortic surgery or heart surgery.
- Revascularization of visceral arteries during the TEVAR
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hanzhou, Zhejiang
About this study
Official title: Antibiotic Prophylaxis for Thoracic EndoVascular Aortic Repair
The infection rate of thoracic endovascular aortic repair (TEVAR) is unknown due to a lack of epidemiological data. The rate currently available comes from researches conducted decades ago, when open surgery was the standard of care. Because of the potentially fatal consequences of a stent graft infection in the thoracic aorta, the investigators tend to prescribe antibiotic prophylaxis for at least three days. In this study, the investigators are going to collect data on patients receiving TEVAR in the past five years and provide the following information: a. the infection rate (MAGIC classification), b. the rate of fever, c. the results of the lab tests, such as the WBC count and C-reaction protein. d. risk factors associated with infection and fever.
- Conditions
- Aortic Dissection, Aortic Diseases, Aortic Aneurysm, Thoracic, Coarctation of Aorta, Hematoma; Aorta
- Being tested
- thoracic endovascular aortic repair
- Keywords
- Antibiotic prophylaxis, TEVAR, Fever, MAGIC classification
- Medical subject headings
- Aortic Dissection, Aortic Diseases, Aortic Aneurysm, Thoracic, Aortic Coarctation, Hematoma, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic endovascular aortic repairProcedure or surgery
In The TEVAR procedure, we implant a stent graft into the diseased area of the thoracic artery, providing a route for the blood to flow within the stent graft and excluding the diseased aorta.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving TEVAR | Not described Receives: Procedure: thoracic endovascular aortic repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection rate after TEVAR
Infection rate via MAGIC classification
Measured: during hospitalization (up to post-operation day 14)
Infection rate at one month after TEVAR
Infection rate via MAGIC classification
Measured: One month after TEVAR
Infection rate at six months after TEVAR
Infection rate via MAGIC classification
Measured: Six months after TEVAR
Infection rate at one year after TEVAR
Infection rate via MAGIC classification
Measured: One year after TEVAR
Secondary outcomes (3)
Fever
Defined as temperature ≥38.5℃
Measured: one day, two days, three days, one month, six months, one year after TEVAR
WBC count
Measured: one day, two days, three days after TEVAR
C-reaction protein
Measured: one day after TEVAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start1 Jan 2022
- Primary completion1 Jan 2023
- Study completion1 Sep 2025
Why it stopped: Unable to enroll a sufficient number of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongkun Zhang, MD, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405790
- Sponsor's protocol ID
- IIT20220172A
- Status last verified
- Sep 2025
- First submitted
- 30 May 2022
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis for Thoracic EndoVascular Aortic Repair
- ClinicalTrials.gov ID
- NCT05405790
- Acronym / sponsor ID
- IIT20220172A
- Conditions
- Aortic Dissection, Aortic Diseases, Aortic Aneurysm, Thoracic, Coarctation of Aorta, Hematoma; Aorta
- Keywords
- Antibiotic prophylaxis, TEVAR, Fever, MAGIC classification
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to enroll a sufficient number of patients
- Enrolment
- 457 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 6 Jun 2022 (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 infection rate of thoracic endovascular aortic repair (TEVAR) is unknown due to a lack of epidemiological data. The rate currently available comes from researches conducted decades ago, when open surgery was the standard of care. Because of the potentially fatal consequences of a stent graft infection in the thoracic aorta, the investigators tend to prescribe antibiotic prophylaxis for at least three days. In this study, the investigators are going to collect data on patients receiving TEVAR in the past five years and provide the following information: a. the infection rate (MAGIC classification), b. the rate of fever, c. the results of the lab tests, such as the WBC count and C-reaction protein. d. risk factors associated with infection and fever.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving TEVAR | – | Procedure: thoracic endovascular aortic repair |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who were diagnosed with thoracic aortic dissection, thoracic aortic aneurysm, thoracic aortic intramural hematoma, or other thoracic aortic diseases and underwent TEVAR during hospitalization
Key inclusion criteria (2 listed)
- Diagnosed with thoracic aortic diseases
- Received TEVAR
Key exclusion criteria (8 listed)
- Suspected infectious aortic disease, such as a mycotic aneurysm.
- TEVAR combined with open surgery
- Antibiotics have been used more than 24 hours before the operation
- Combined with immune deficiency disease or using hormone or immunosuppressant；
- The treatment is for the complications of TEVAR, such as endoleak
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 |
|---|---|---|
| thoracic endovascular aortic repairIn The TEVAR procedure, we implant a stent graft into the diseased area of the thoracic artery, providing a route for the blood to flow within the stent graft and excluding the diseased aorta. | Procedure or surgery | Patients receiving TEVAR |
Primary outcome
Infection rate after TEVAR
Time frame: during hospitalization (up to post-operation day 14)
Infection rate via MAGIC classification
Infection rate at one month after TEVAR
Time frame: One month after TEVAR
Infection rate via MAGIC classification
Infection rate at six months after TEVAR
Time frame: Six months after TEVAR
Infection rate via MAGIC classification
Infection rate at one year after TEVAR
Time frame: One year after TEVAR
Infection rate via MAGIC classification
3 secondary outcomes
Fever
Time frame: one day, two days, three days, one month, six months, one year after TEVAR
WBC count
Time frame: one day, two days, three days after TEVAR
C-reaction protein
Time frame: one day after TEVAR
Results and safety
The study was stopped early (reason given: Unable to enroll a sufficient number of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Aortic Dissection and Aortic Diseases, run by First Affiliated Hospital of Zhejiang 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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 25 Sep 2025. 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?
The study was stopped early (reason given: Unable to enroll a sufficient number of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection rate after TEVAR (time frame: during hospitalization (up to post-operation day 14)). The study lists 4 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 25 Sep 2025.