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TerminatedNCT05405790Updated Sep 25, 2025

Antibiotic Prophylaxis for TEVAR

An observational study in Aortic Dissection, Aortic Diseases and Aortic Aneurysm, Thoracic, sponsored by First Affiliated Hospital of Zhejiang University. Terminated at 1 site in China. Per ClinicalTrials.gov, last updated 2025-09-25.

Sponsored by First Affiliated Hospital of Zhejiang University · Observational

Why this study was terminated
Unable to enroll a sufficient number of patients
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
457
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Aortic Dissection
  • Aortic Diseases
  • Aortic Aneurysm, Thoracic
  • Coarctation of Aorta
  • Hematoma; Aorta

Keywords

  • Antibiotic prophylaxis
  • TEVAR
  • Fever
  • MAGIC classification
03

In context

Aortic Dissection

205 studies on the registry are indexed under Aortic Dissection; 73 are open to participants now.

This study's enrollment of 457 is above the median of 230 across 115 observational studies indexed under Aortic Dissection.

Browse Aortic Dissection studies →

Lead sponsor

First Affiliated Hospital of Zhejiang University is the lead sponsor of 263 studies on the registry; 144 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Diagnosed with thoracic aortic diseases
  2. Received TEVAR

Exclusion criteria

Exclusion Criteria:

  1. Suspected infectious aortic disease, such as a mycotic aneurysm.
  2. TEVAR combined with open surgery
  3. Antibiotics have been used more than 24 hours before the operation
  4. Combined with immune deficiency disease or using hormone or ;
  5. The treatment is for the complications of TEVAR, such as endoleak
  6. Endovascular aortic repair for abdominal aortic disease
  7. History of open aortic surgery or heart surgery.
  8. Revascularization of visceral arteries during the TEVAR
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
457 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients receiving TEVAR

    Procedure: thoracic endovascular aortic repair

Interventions

  • Procedurethoracic endovascular aortic repair

    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.

06

What researchers measure

Primary outcomes

  1. Infection rate after TEVAR

    Infection rate via MAGIC classification

    Time frame: during hospitalization (up to post-operation day 14)

  2. Infection rate at one month after TEVAR

    Infection rate via MAGIC classification

    Time frame: One month after TEVAR

  3. Infection rate at six months after TEVAR

    Infection rate via MAGIC classification

    Time frame: Six months after TEVAR

  4. Infection rate at one year after TEVAR

    Infection rate via MAGIC classification

    Time frame: One year after TEVAR

Secondary outcomes

  1. Fever

    Defined as temperature ≥38.5℃

    Time frame: one day, two days, three days, one month, six months, one year after TEVAR

  2. WBC count

    Time frame: one day, two days, three days after TEVAR

  3. C-reaction protein

    Time frame: one day after TEVAR

07

Study locations

1 site
  • The First Affiliated Hospital, College of Medicine, Zhejiang University
    Hanzhou, Zhejiang, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2022 to primary completion in Jan 2023, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 30, 2022
First posted
Jun 6, 2022
StartActual
Jan 1, 2022
Primary completionActual
Jan 1, 2023
CompletionActual
Sep 1, 2025
Last update
Sep 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05405790
Responsible party
Hongkun Zhang, MD (Head of Vascular Surgery, First Affiliated Hospital of Zhejiang University) — Principal investigator
First posted
Jun 6, 2022
Start date
Jan 1, 2022
Primary completion
Jan 1, 2023
Completion
Sep 1, 2025
Last update
Sep 25, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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