Antibiotic Prophylaxis for TEVAR

NCT05405790 | Terminated

• 1 other identifier: IIT20220172A
• Study Type: observational
• Target: 457
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Antibiotic prophylaxis; TEVAR; Fever; MAGIC classification

Outcome Measures

Primary Outcomes (4)

• Infection rate after TEVAR

  Infection rate via MAGIC classification

  during hospitalization (up to post-operation day 14)

• Infection rate at one month after TEVAR

  Infection rate via MAGIC classification

  One month after TEVAR

• Infection rate at six months after TEVAR

  Infection rate via MAGIC classification

  Six months after TEVAR

• Infection rate at one year after TEVAR

  Infection rate via MAGIC classification

  One year after TEVAR

Secondary Outcomes (3)

• Fever

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

• WBC count

  one day, two days, three days after TEVAR

• C-reaction protein

  one day after TEVAR

Study Arms (1)

Patients receiving TEVAR

Procedure: thoracic endovascular aortic repair

Interventions

thoracic endovascular aortic repair PROCEDURE

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.

Patients receiving TEVAR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Diagnosed with thoracic aortic diseases
• Received TEVAR

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hanzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Aortic Dissection; Aortic Diseases; Aortic Aneurysm, Thoracic; Aortic Coarctation; Hematoma; Fever

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Aneurysm; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Vascular Surgery

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 6, 2022
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: September 1, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

CN (1)