Antibiotic Prophylaxis for TEVAR

NCT ID: NCT05405790

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 457 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2025-09-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients receiving TEVAR

thoracic endovascular aortic repair

Intervention Type: 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.

Interventions

thoracic 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Diagnosed with thoracic aortic diseases

2. Received TEVAR

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 immunosuppressant；

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Hongkun Zhang, MD

Head of Vascular Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hanzhou, Zhejiang, China

Countries

China

Other Identifiers

IIT20220172A

Identifier Type: -

Identifier Source: org_study_id